Ignite Creation Date:
2025-12-24 @ 12:32 PM
Ignite Modification Date:
2025-12-28 @ 9:00 AM
Study NCT ID:
NCT01712061
Status:
COMPLETED
Last Update Posted:
2015-10-21
First Post:
2012-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Phase 2 Multi-Center Study To Evaluate The Efficacy And Safety Of A Chemokine CCR2/5 Receptor Antagonist In Adults With Type 2 Diabetes And Overt Nephropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003928', 'term': 'Diabetic Nephropathies'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D000419', 'term': 'Albuminuria'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D011507', 'term': 'Proteinuria'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000629947', 'term': 'PF-04634817'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline up to 28 days after last study drug administration', 'description': 'The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'PF-04634817 150 mg', 'description': 'Participants with estimated glomerular filtration rate (eGFR) values of 20 to less than (\\<)30 milliliters/minute (mL/min)/1.73 square meter (m\\^2) were dosed orally at 150 mg once daily (QD) for 12 weeks.', 'otherNumAtRisk': 30, 'otherNumAffected': 11, 'seriousNumAtRisk': 30, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'PF-04634817 200 mg', 'description': 'Participants with eGFR values of 30 to 75 mL/min/1.73 m\\^2 were dosed orally at 200 mg QD for 12 weeks.', 'otherNumAtRisk': 140, 'otherNumAffected': 40, 'seriousNumAtRisk': 140, 'seriousNumAffected': 11}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Participants were dosed orally with matching placebo tablets QD for 12 weeks.', 'otherNumAtRisk': 56, 'otherNumAffected': 15, 'seriousNumAtRisk': 56, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'seriousEvents': [{'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Generalised oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Localised infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Gouty arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Erythrodermic psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Homicide', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 140, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 56, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Reduction From Baseline in Urinary Albumin to Creatinine Ratio (UACR) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04634817 200 mg/150 mg', 'description': 'Participants were dosed orally at 150 mg (eGFR 20-\\<30 mL/min/1.73 m\\^2) or 200 mg (30-75 mL/min/1.73 m\\^2) QD for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were dosed orally with matching placebo tablets QD for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.27', 'spread': '5.43', 'groupId': 'OG000', 'lowerLimit': '3.14', 'upperLimit': '24.62'}, {'value': '5.02', 'spread': '6.87', 'groupId': 'OG001', 'lowerLimit': '-7.90', 'upperLimit': '18.70'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of geometric mean changes', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.92', 'ciLowerLimit': '0.75', 'ciUpperLimit': '1.09', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Bayesian ANCOVA with covariates for baseline UACR and systolic blood pressure (SBP).', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'The presence of albumin in the urine (macroalbuminuria) is a marker of kidney disease. Albumin and creatinine concentrations were obtained from spot urine samples.', 'unitOfMeasure': 'percent (%)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) was defined as all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 post-dose efficacy measurement; n=number of participants analyzed in respective arms for category.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in UACR at Weeks 4, 8 and 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04634817 200 mg/150 mg', 'description': 'Participants were dosed orally at 150 mg (eGFR 20-\\<30 mL/min/1.73 m\\^2) or 200 mg (30-75 mL/min/1.73 m\\^2) QD for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were dosed orally with matching placebo tablets QD for 12 weeks.'}], 'classes': [{'title': 'Baseline (n=157,50)', 'categories': [{'measurements': [{'value': '127.41', 'spread': '96', 'groupId': 'OG000'}, {'value': '121.80', 'spread': '88', 'groupId': 'OG001'}]}]}, {'title': 'Change From Baseline at Week 4 (n=148,46)', 'categories': [{'measurements': [{'value': '0.89', 'spread': '66', 'groupId': 'OG000'}, {'value': '0.91', 'spread': '88', 'groupId': 'OG001'}]}]}, {'title': 'Change From Baseline at Week 8 (n=134,43)', 'categories': [{'measurements': [{'value': '0.90', 'spread': '62', 'groupId': 'OG000'}, {'value': '0.94', 'spread': '57', 'groupId': 'OG001'}]}]}, {'title': 'Change From Baseline at Week 16 (n=126,37)', 'categories': [{'measurements': [{'value': '0.93', 'spread': '72', 'groupId': 'OG000'}, {'value': '0.92', 'spread': '56', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline, Weeks 4, 8 and 16', 'description': 'The presence of albumin in the urine (macroalbuminuria) is a marker of kidney disease. Albumin and creatinine concentrations were obtained from spot urine samples.', 'unitOfMeasure': 'mg/millimolar creatinine (mmolCr)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS was defined as all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 post-dose efficacy measurement; n=number of participants analyzed in respective arms for category.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Urinary Protein to Creatinine Ratio (UPCR) at Weeks 4, 8, 12 and 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04634817 200 mg/150 mg', 'description': 'Participants were dosed orally at 150 mg (eGFR 20-\\<30 mL/min/1.73 m\\^2) or 200 mg (30-75 mL/min/1.73 m\\^2) QD for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were dosed orally with matching placebo tablets QD for 12 weeks.'}], 'classes': [{'title': 'Baseline (n=155,49)', 'categories': [{'measurements': [{'value': '185.42', 'spread': '97', 'groupId': 'OG000'}, {'value': '176.31', 'spread': '82', 'groupId': 'OG001'}]}]}, {'title': 'Change From Baseline at Week 4 (n=143,45)', 'categories': [{'measurements': [{'value': '0.93', 'spread': '47', 'groupId': 'OG000'}, {'value': '0.92', 'spread': '76', 'groupId': 'OG001'}]}]}, {'title': 'Change From Baseline at Week 8 (n=130,42)', 'categories': [{'measurements': [{'value': '0.92', 'spread': '50', 'groupId': 'OG000'}, {'value': '0.94', 'spread': '46', 'groupId': 'OG001'}]}]}, {'title': 'Change From Baseline at Week 12 (n=125,42)', 'categories': [{'measurements': [{'value': '0.92', 'spread': '58', 'groupId': 'OG000'}, {'value': '0.92', 'spread': '79', 'groupId': 'OG001'}]}]}, {'title': 'Change From Baseline at Week 16 (n=125,36)', 'categories': [{'measurements': [{'value': '0.95', 'spread': '58', 'groupId': 'OG000'}, {'value': '0.92', 'spread': '55', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline, Weeks 4, 8, 12 and 16', 'description': 'The presence of protein in the urine (proteinuria) often implies kidney disease. Protein and creatinine concentrations were obtained from spot urine samples.', 'unitOfMeasure': 'mg/mmolCr', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS was defined as all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 post-dose efficacy measurement; n=number of participants analyzed in respective arms for category.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) Using the Abbreviated Modified Diet in Renal Disease (MDRD) Formula at Weeks 1, 4, 8, 12 and 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04634817 200 mg/150 mg', 'description': 'Participants were dosed orally at 150 mg (eGFR 20-\\<30 mL/min/1.73 m\\^2) or 200 mg (30-75 mL/min/1.73 m\\^2) QD for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were dosed orally with matching placebo tablets QD for 12 weeks.'}], 'classes': [{'title': 'Baseline (n=159,51)', 'categories': [{'measurements': [{'value': '41.80', 'spread': '12.18', 'groupId': 'OG000'}, {'value': '41.65', 'spread': '13.46', 'groupId': 'OG001'}]}]}, {'title': 'Change From Baseline at Week 1 (n=157,50)', 'categories': [{'measurements': [{'value': '-0.77', 'spread': '5.80', 'groupId': 'OG000'}, {'value': '-0.35', 'spread': '5.28', 'groupId': 'OG001'}]}]}, {'title': 'Change From Baseline at Week 4 (n=157,51)', 'categories': [{'measurements': [{'value': '-1.07', 'spread': '5.37', 'groupId': 'OG000'}, {'value': '-1.32', 'spread': '5.12', 'groupId': 'OG001'}]}]}, {'title': 'Change From Baseline at Week 8 (n=147,47)', 'categories': [{'measurements': [{'value': '-1.60', 'spread': '5.34', 'groupId': 'OG000'}, {'value': '-2.15', 'spread': '6.83', 'groupId': 'OG001'}]}]}, {'title': 'Change From Baseline at Week 12 (n=136,45)', 'categories': [{'measurements': [{'value': '-1.14', 'spread': '5.70', 'groupId': 'OG000'}, {'value': '-1.03', 'spread': '5.75', 'groupId': 'OG001'}]}]}, {'title': 'Change From Baseline at Week 16 (n=134,44)', 'categories': [{'measurements': [{'value': '-2.14', 'spread': '6.42', 'groupId': 'OG000'}, {'value': '-1.18', 'spread': '5.58', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 1, 4, 8, 12 and 16', 'description': 'eGFR was calculated using the MDRD equation and normalized to 1.73 m\\^2 body surface area. Age and corresponding creatinine at each visit (Weeks 1, 4, 8, 12 and 16) were used to calculate GFR', 'unitOfMeasure': 'mL/min/1.73m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS was defined as all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 post-dose efficacy measurement; n=number of participants analyzed in respective arms for category.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in eGFR Using Cystatin Formula at Weeks 12 and 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04634817 200 mg/150 mg', 'description': 'Participants were dosed orally at 150 mg (eGFR 20-\\<30 mL/min/1.73 m\\^2) or 200 mg (30-75 mL/min/1.73 m\\^2) QD for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were dosed orally with matching placebo tablets QD for 12 weeks.'}], 'classes': [{'title': 'Baseline (n=159,50)', 'categories': [{'measurements': [{'value': '45.28', 'spread': '14.22', 'groupId': 'OG000'}, {'value': '45.36', 'spread': '14.94', 'groupId': 'OG001'}]}]}, {'title': 'Change From Baseline at Week 12 (n=135,44)', 'categories': [{'measurements': [{'value': '-1.10', 'spread': '6.30', 'groupId': 'OG000'}, {'value': '-0.70', 'spread': '5.49', 'groupId': 'OG001'}]}]}, {'title': 'Change From Baseline at Week 16 (n=134,43)', 'categories': [{'measurements': [{'value': '-2.27', 'spread': '6.77', 'groupId': 'OG000'}, {'value': '-0.91', 'spread': '6.30', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12, and Week 16', 'description': 'Serum cystatin C may be a more reliable endogenous marker of GFR than serum creatinine. eGFR was calculated using the Cystatin Formula and normalized to 1.73 m\\^2 body surface area.', 'unitOfMeasure': 'mL/min/1.73m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS was defined as all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 post-dose efficacy measurement; n=number of participants analyzed in respective arms for category.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Serum Creatinine at Weeks 1, 4, 8, 12 and 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04634817 200 mg/150 mg', 'description': 'Participants were dosed orally at 150 mg (eGFR 20-\\<30 mL/min/1.73 m\\^2) or 200 mg (30-75 mL/min/1.73 m\\^2) QD for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were dosed orally with matching placebo tablets QD for 12 weeks.'}], 'classes': [{'title': 'Baseline (n=159,51)', 'categories': [{'measurements': [{'value': '1.72', 'spread': '0.51', 'groupId': 'OG000'}, {'value': '1.77', 'spread': '0.51', 'groupId': 'OG001'}]}]}, {'title': 'Change From Baseline at Week 1 (n=158,50)', 'categories': [{'measurements': [{'value': '0.05', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '0.17', 'groupId': 'OG001'}]}]}, {'title': 'Change From Baseline at Week 4 (n=157,51)', 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '0.11', 'spread': '0.30', 'groupId': 'OG001'}]}]}, {'title': 'Change From Baseline at Week 8 (n=147,47)', 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '0.09', 'spread': '0.24', 'groupId': 'OG001'}]}]}, {'title': 'Change From Baseline at Week 12 (n=137,45)', 'categories': [{'measurements': [{'value': '0.05', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '0.08', 'spread': '0.20', 'groupId': 'OG001'}]}]}, {'title': 'Change From Baseline at Week 16 (n=134,44)', 'categories': [{'measurements': [{'value': '0.09', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '0.09', 'spread': '0.29', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 1, 4, 8, 12 and 16', 'description': 'Serum creatinine is an indicator of kidney function. Creatinine is a substance formed from the metabolism of creatine, commonly found in blood, urine, and muscle tissue. It is removed from the blood by the kidneys and excreted in urine. Normal adult blood levels of creatinine=45 to 90 micromoles per liter (mcmol/L) for females, 60 to 110 mcmol/L for males, however normal values are age-dependent. Change from baseline=creatinine level at Week 1, 4, 8, 12 or 16 minus baseline level where higher scores represented decreased kidney function.', 'unitOfMeasure': 'milligrams per deciliter (mg/dL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS was defined as all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 post-dose efficacy measurement; n=number of participants analyzed in respective arms for category.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Serum Cystatin C at Weeks 12 and 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04634817 200 mg/150 mg', 'description': 'Participants were dosed orally at 150 mg (eGFR 20-\\<30 mL/min/1.73 m\\^2) or 200 mg (30-75 mL/min/1.73 m\\^2) QD for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were dosed orally with matching placebo tablets QD for 12 weeks.'}], 'classes': [{'title': 'Baseline (n=159,51)', 'categories': [{'measurements': [{'value': '1.54', 'spread': '0.43', 'groupId': 'OG000'}, {'value': '1.52', 'spread': '0.41', 'groupId': 'OG001'}]}]}, {'title': 'Change From Baseline at Week 12 (n=136,45)', 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '0.21', 'groupId': 'OG001'}]}]}, {'title': 'Change From Baseline at Week 16 (n=134,44)', 'categories': [{'measurements': [{'value': '0.05', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '0.06', 'spread': '0.25', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12, and Week 16', 'description': 'Cystatin C is a protein which is mainly used as a biomarker of kidney function. If kidney function and GFR decline, the blood levels of cystatin C rise.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS was defined as all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 post-dose efficacy measurement; n=number of participants analyzed in respective arms for category.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Plasma Glycosylated Hemoglobin (HbA1c) at Weeks 4, 8, 12 and 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04634817 200 mg/150 mg', 'description': 'Participants were dosed orally at 150 mg (eGFR 20-\\<30 mL/min/1.73 m\\^2) or 200 mg (30-75 mL/min/1.73 m\\^2) QD for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were dosed orally with matching placebo tablets QD for 12 weeks.'}], 'classes': [{'title': 'Baseline (n=159,51)', 'categories': [{'measurements': [{'value': '7.51', 'spread': '1.22', 'groupId': 'OG000'}, {'value': '7.91', 'spread': '1.42', 'groupId': 'OG001'}]}]}, {'title': 'Change From Baseline at Week 4 (n=157,51)', 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.46', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '0.46', 'groupId': 'OG001'}]}]}, {'title': 'Change From Baseline at Week 8 (n=147,46)', 'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.64', 'groupId': 'OG000'}, {'value': '-0.08', 'spread': '0.71', 'groupId': 'OG001'}]}]}, {'title': 'Change From Baseline at Week 12 (n=137,44)', 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '-0.06', 'spread': '0.81', 'groupId': 'OG001'}]}]}, {'title': 'Change From Baseline at Week 16 (n=133,44)', 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.89', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '1.13', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 4, 8, 12 and 16', 'description': 'HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. As the average amount of plasma glucose increases, the fraction of HbA1c increases in a predictable way.', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS was defined as all participants randomized and who had received at least 1 dose of randomized treatment and had at least 1 post-dose efficacy measurement; n=number of participants analyzed in respective arms for category.'}, {'type': 'SECONDARY', 'title': 'Summary of Plasma PF-04634817 Pharmacokinetic (PK) Concentrations at Day 1 and Weeks 1, 4, 8 and 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04634817 150 mg', 'description': 'Participants with estimated glomerular filtration rate (eGFR) values of 20 to less than (\\<)30 milliliters/minute (mL/min)/1.73 square meter (m\\^2) were dosed orally at 150 mg once daily (QD) for 12 weeks.'}, {'id': 'OG001', 'title': 'PF-04634817 200 mg', 'description': 'Participants with eGFR values of 30 to 75 mL/min/1.73 m\\^2 were dosed orally at 200 mg QD for 12 weeks.'}], 'classes': [{'title': 'Day 1: 1 Hour Post-Dose (n=29,124)', 'categories': [{'measurements': [{'value': '434.5', 'spread': '65', 'groupId': 'OG000'}, {'value': '524.4', 'spread': '83', 'groupId': 'OG001'}]}]}, {'title': 'Day 1: 2 Hours Post-Dose (n=30,139)', 'categories': [{'measurements': [{'value': '579.3', 'spread': '37', 'groupId': 'OG000'}, {'value': '602.9', 'spread': '52', 'groupId': 'OG001'}]}]}, {'title': 'Day 1: 4 Hours Post-Dose (n=29,137)', 'categories': [{'measurements': [{'value': '497.4', 'spread': '38', 'groupId': 'OG000'}, {'value': '547.7', 'spread': '46', 'groupId': 'OG001'}]}]}, {'title': 'Week 1: Pre-Dose (n=28,131)', 'categories': [{'measurements': [{'value': '294.4', 'spread': '60', 'groupId': 'OG000'}, {'value': '231.2', 'spread': '73', 'groupId': 'OG001'}]}]}, {'title': 'Week 1: 2 Hours Post-Dose (n=28,132)', 'categories': [{'measurements': [{'value': '884.8', 'spread': '42', 'groupId': 'OG000'}, {'value': '865.0', 'spread': '55', 'groupId': 'OG001'}]}]}, {'title': 'Week 4: Pre-Dose (n=25,126)', 'categories': [{'measurements': [{'value': '231.3', 'spread': '51', 'groupId': 'OG000'}, {'value': '239.5', 'spread': '87', 'groupId': 'OG001'}]}]}, {'title': 'Week 4: 2 Hours Post-Dose (n=24,122)', 'categories': [{'measurements': [{'value': '785.8', 'spread': '45', 'groupId': 'OG000'}, {'value': '918', 'spread': '55', 'groupId': 'OG001'}]}]}, {'title': 'Week 8: Pre-Dose (n=23,113)', 'categories': [{'measurements': [{'value': '310.2', 'spread': '79', 'groupId': 'OG000'}, {'value': '245.2', 'spread': '77', 'groupId': 'OG001'}]}]}, {'title': 'Week 8: 2 Hours Post-Dose (n=23,114)', 'categories': [{'measurements': [{'value': '730.0', 'spread': '70', 'groupId': 'OG000'}, {'value': '895', 'spread': '57', 'groupId': 'OG001'}]}]}, {'title': 'Week 12 (n=20,113)', 'categories': [{'measurements': [{'value': '320.1', 'spread': '75', 'groupId': 'OG000'}, {'value': '252.3', 'spread': '84', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1, 2, 4 hours post-dose on Day 1; 2 hours post-dose on Weeks 1, 4, 8 and 12', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK Concentration Analysis Set is defined as all participants in the FAS for whom a PK sample was obtained and analyzed; n=number of participants analyzed in respective arms for category.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 1, 4, 8, 12 and 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04634817 200 mg/150 mg', 'description': 'Participants were dosed orally at 150 mg (eGFR 20-\\<30 mL/min/1.73 m\\^2) or 200 mg (30-75 mL/min/1.73 m\\^2) QD for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were dosed orally with matching placebo tablets QD for 12 weeks.'}], 'classes': [{'title': 'Supine SBP: Baseline (n=168,53)', 'categories': [{'measurements': [{'value': '140.4', 'spread': '13.96', 'groupId': 'OG000'}, {'value': '139.9', 'spread': '13.60', 'groupId': 'OG001'}]}]}, {'title': 'Supine SBP:Change From Baseline Week 1 (n=164,53)', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '12.75', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '12.87', 'groupId': 'OG001'}]}]}, {'title': 'Supine SBP:Change From Baseline Week 4 (n=154,49)', 'categories': [{'measurements': [{'value': '-0.5', 'spread': '15.43', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '14.19', 'groupId': 'OG001'}]}]}, {'title': 'Supine SBP:Change From Baseline Week 8 (n=142,47)', 'categories': [{'measurements': [{'value': '-3.4', 'spread': '12.94', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '13.71', 'groupId': 'OG001'}]}]}, {'title': 'Supine SBP:Change From Baseline Week 12 (n=134,45)', 'categories': [{'measurements': [{'value': '-2.0', 'spread': '13.28', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '13.23', 'groupId': 'OG001'}]}]}, {'title': 'Supine SBP:Change From Baseline Week 16 (n=138,45)', 'categories': [{'measurements': [{'value': '-2.4', 'spread': '15.14', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '14.41', 'groupId': 'OG001'}]}]}, {'title': 'Supine DBP: Baseline (n=168,53)', 'categories': [{'measurements': [{'value': '75.9', 'spread': '8.97', 'groupId': 'OG000'}, {'value': '77.1', 'spread': '6.88', 'groupId': 'OG001'}]}]}, {'title': 'Supine DBP:Change From Baseline Week 1 (n=164,53)', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '6.94', 'groupId': 'OG000'}, {'value': '-2.7', 'spread': '7.58', 'groupId': 'OG001'}]}]}, {'title': 'Supine DBP:Change From Baseline Week 4 (n=154,49)', 'categories': [{'measurements': [{'value': '0.1', 'spread': '8.23', 'groupId': 'OG000'}, {'value': '-1.8', 'spread': '7.47', 'groupId': 'OG001'}]}]}, {'title': 'Supine DBP:Change From Baseline Week 8 (n=142,47)', 'categories': [{'measurements': [{'value': '-1.9', 'spread': '7.46', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '7.05', 'groupId': 'OG001'}]}]}, {'title': 'Supine DBP:Change From Baseline Week 12 (n=134,45)', 'categories': [{'measurements': [{'value': '-0.9', 'spread': '6.88', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '6.69', 'groupId': 'OG001'}]}]}, {'title': 'Supine DBP:Change From Baseline Week 16 (n=138,45)', 'categories': [{'measurements': [{'value': '-1.7', 'spread': '7.98', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '8.40', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 1, 4, 8, 12 and 16', 'unitOfMeasure': 'millimeters of mercury (mm Hg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Analysis Set is defined as all participants who receive at least 1 dose of study medication; n=number of participants analyzed in respective arms for category.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Pulse Rate at Weeks 1, 4, 8, 12 and 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04634817 200 mg/150 mg', 'description': 'Participants were dosed orally at 150 mg (eGFR 20-\\<30 mL/min/1.73 m\\^2) or 200 mg (30-75 mL/min/1.73 m\\^2) QD for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were dosed orally with matching placebo tablets QD for 12 weeks.'}], 'classes': [{'title': 'Baseline (n=168,53)', 'categories': [{'measurements': [{'value': '68.7', 'spread': '9.74', 'groupId': 'OG000'}, {'value': '69.3', 'spread': '9.30', 'groupId': 'OG001'}]}]}, {'title': 'Change From Baseline at Week 1 (n=164,53)', 'categories': [{'measurements': [{'value': '0.1', 'spread': '5.86', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '5.63', 'groupId': 'OG001'}]}]}, {'title': 'Change From Baseline at Week 4 (n=154,49)', 'categories': [{'measurements': [{'value': '0.3', 'spread': '6.01', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '6.63', 'groupId': 'OG001'}]}]}, {'title': 'Change From Baseline at Week 8 (n=142,47)', 'categories': [{'measurements': [{'value': '0.2', 'spread': '6.54', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '6.77', 'groupId': 'OG001'}]}]}, {'title': 'Change From Baseline at Week 12 (n=134,45)', 'categories': [{'measurements': [{'value': '0.2', 'spread': '7.03', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '7.33', 'groupId': 'OG001'}]}]}, {'title': 'Change From Baseline at Week 16 (n=138,45)', 'categories': [{'measurements': [{'value': '1.4', 'spread': '8.22', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '6.92', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 1, 4, 8, 12 and 16', 'unitOfMeasure': 'beats per minute (bpm)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Analysis Set is defined as all participants who receive at least 1 dose of study medication; n=number of participants analyzed in respective arms for category.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change From Baseline in Body Weight at Weeks 1, 4, 8, 12 and 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04634817 200 mg/150 mg', 'description': 'Participants were dosed orally at 150 mg (eGFR 20-\\<30 mL/min/1.73 m\\^2) or 200 mg (30-75 mL/min/1.73 m\\^2) QD for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were dosed orally with matching placebo tablets QD for 12 weeks.'}], 'classes': [{'title': 'Baseline (n=167,53)', 'categories': [{'measurements': [{'value': '93.8', 'spread': '23.97', 'groupId': 'OG000'}, {'value': '95.1', 'spread': '25.95', 'groupId': 'OG001'}]}]}, {'title': 'Change From Baseline at Week 1 (n=163,53)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '1.03', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '1.42', 'groupId': 'OG001'}]}]}, {'title': 'Change From Baseline at Week 4 (n=153,49)', 'categories': [{'measurements': [{'value': '-0.0', 'spread': '1.74', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '3.29', 'groupId': 'OG001'}]}]}, {'title': 'Change From Baseline at Week 8 (n=141,47)', 'categories': [{'measurements': [{'value': '0.1', 'spread': '2.45', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '2.74', 'groupId': 'OG001'}]}]}, {'title': 'Change From Baseline at Week 12 (n=134,45)', 'categories': [{'measurements': [{'value': '0.3', 'spread': '2.66', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '3.02', 'groupId': 'OG001'}]}]}, {'title': 'Change From Baseline at Week 16 (n=137,45)', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '2.79', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '3.37', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 1, 4, 8, 12 and 16', 'unitOfMeasure': 'kilograms (kg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Analysis Set is defined as all participants who receive at least 1 dose of study medication; n=number of participants analyzed in respective arms for category.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04634817 200 mg/150 mg', 'description': 'Participants were dosed orally at 150 mg (eGFR 20-\\<30 mL/min/1.73 m\\^2) or 200 mg (30-75 mL/min/1.73 m\\^2) QD for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were dosed orally with matching placebo tablets QD for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '154', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Week 16 (follow-up visit)', 'description': 'The following laboratory parameters were analyzed for abnormalities at any time point mentioned in the timeframe: clinical chemistry (sodium, potassium, chloride, bicarbonate, phosphate, glucose, blood urea nitrogen \\[BUN\\], creatinine, albumin, calcium, bilirubin \\[total, direct, and indirect\\], gamma-glutamyl transferase \\[GGT\\], alanine aminotransferase \\[ALT\\], aspartate aminotransferase \\[AST\\], lactic dehydrogenase \\[LDH\\], alkaline phosphatase, creatine phosphokinase \\[CPK\\], uric acid, amylase and lipase); hematology (hemoglobin, hematocrit, red blood cell \\[RBC\\] count, white blood cell \\[WBC\\] count with differential, and platelet count); FSH (for postmenopausal women who had been amenorrheic for less than 2 years prior to screening).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Analysis Set is defined as all participants who receive at least 1 dose of study medication; number of participants analyzed (N) is number of evaluable participants for this outcome measure.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04634817 200 mg/150 mg', 'description': 'Participants were dosed orally at 150 mg (eGFR 20-\\<30 mL/min/1.73 m\\^2) or 200 mg (30-75 mL/min/1.73 m\\^2) QD for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were dosed orally with matching placebo tablets QD for 12 weeks.'}], 'classes': [{'title': 'Maximum PR Interval >=300 msec (n=164,55)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Maximum QRS Complex >=140 msec (n=169,56)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Maximum QT Interval >=500 msec (n=169,56)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Maximum QTc Interval 450-<480 msec (n=169,56)', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Maximum QTc Interval 480-<500 msec (n=169,56)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Maximum QTc Interval >=500 msec (n=169,56)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Maximum QTcF Interval 450-<480 msec (n=169,56)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Maximum QTcF Interval 480-<500 msec (n=169,56)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Maximum QTcF Interval >=500 msec (n=169,56)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'PR Interval >=25/50% IFB (n=163,53)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'QRS Complex >=50% IFB (n=169,55)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'QTc Interval 30-<60 msec IFB (n=169,55)', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'QTc Interval >=60 msec IFB (n=169,55)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'QTcF Interval 30-<60 msec IFB (n=169,55)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'QTcF Interval >=60 msec IFB (n=169,55)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Weeks 1, 4 and 12', 'description': "Criteria for potentially clinically important ECG values were defined as: PR interval \\>=300 milliseconds (msec) or \\>=25%/50% increase when baseline is \\>200 msec and ≥50% increase when baseline is less than or equal to (\\<=)200 msec; QRS interval \\>=140 msec or \\>=50% increase from baseline (IFB); QTc \\>=450 msec or \\>=30 msec increase; corrected QT interval using Fridericia's formula (QTcF) \\>=450 msec or \\>=30 msec increase.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Analysis Set is defined as all participants who receive at least 1 dose of study medication; n=number of participants analyzed in respective arms for category.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04634817 200 mg/150 mg', 'description': 'Participants were dosed orally at 150 mg (eGFR 20-\\<30 mL/min/1.73 m\\^2) or 200 mg (30-75 mL/min/1.73 m\\^2) QD for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were dosed orally with matching placebo tablets QD for 12 weeks.'}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '106', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 28 days after last study drug administration', 'description': 'An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of treatment and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-serious AEs.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Analysis Set is defined as all participants who receive at least 1 dose of study medication.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Increased Fasting Blood Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04634817 200 mg/150 mg', 'description': 'Participants were dosed orally at 150 mg (eGFR 20-\\<30 mL/min/1.73 m\\^2) or 200 mg (30-75 mL/min/1.73 m\\^2) QD for 12 weeks.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants were dosed orally with matching placebo tablets QD for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Week 16 (follow-up visit)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Analysis Set is defined as all participants who receive at least 1 dose of study medication; number of participants analyzed (N) is number of evaluable participants for this outcome measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PF-04634817 150 mg', 'description': 'Participants with estimated glomerular filtration rate (eGFR) values of 20 to less than (\\<)30 milliliters/minute (mL/min)/1.73 square meter (m\\^2) were dosed orally at 150 mg once daily (QD) for 12 weeks.'}, {'id': 'FG001', 'title': 'PF-04634817 200 mg', 'description': 'Participants with eGFR values of 30 to 75 mL/min/1.73 m\\^2 were dosed orally at 200 mg QD for 12 weeks.'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Participants were dosed orally with matching placebo tablets QD for 12 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '140'}, {'groupId': 'FG002', 'numSubjects': '56'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '114'}, {'groupId': 'FG002', 'numSubjects': '45'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Did Not Meet Entrance Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Medication Error Without Associated AE', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'The primary entry criterion for participants was based on presence of macroalbuminuria (urine albumin to creatinine ratio \\[UACR\\] greater than or equal to (\\>=)300 milligrams per gram (mg/g).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '226', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'PF-04634817 200 mg/150 mg', 'description': 'Participants were dosed orally at 150 mg (eGFR 20-\\<30 mL/min/1.73 m\\^2) or 200 mg (30-75 mL/min/1.73 m\\^2) QD for 12 weeks.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants were dosed orally with matching placebo tablets QD for 12 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Less than (<) 18 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': '18-44 years', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': '45-64 years', 'categories': [{'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}]}, {'title': '>=65 years', 'categories': [{'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '114', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '134', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '183', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 226}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-22', 'studyFirstSubmitDate': '2012-10-19', 'resultsFirstSubmitDate': '2015-09-22', 'studyFirstSubmitQcDate': '2012-10-19', 'lastUpdatePostDateStruct': {'date': '2015-10-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-09-22', 'studyFirstPostDateStruct': {'date': '2012-10-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 1, 4, 8, 12 and 16', 'timeFrame': 'Baseline, Weeks 1, 4, 8, 12 and 16'}, {'measure': 'Change From Baseline in Pulse Rate at Weeks 1, 4, 8, 12 and 16', 'timeFrame': 'Baseline, Weeks 1, 4, 8, 12 and 16'}, {'measure': 'Change From Baseline in Body Weight at Weeks 1, 4, 8, 12 and 16', 'timeFrame': 'Baseline, Weeks 1, 4, 8, 12 and 16'}, {'measure': 'Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern', 'timeFrame': 'Baseline up to Week 16 (follow-up visit)', 'description': 'The following laboratory parameters were analyzed for abnormalities at any time point mentioned in the timeframe: clinical chemistry (sodium, potassium, chloride, bicarbonate, phosphate, glucose, blood urea nitrogen \\[BUN\\], creatinine, albumin, calcium, bilirubin \\[total, direct, and indirect\\], gamma-glutamyl transferase \\[GGT\\], alanine aminotransferase \\[ALT\\], aspartate aminotransferase \\[AST\\], lactic dehydrogenase \\[LDH\\], alkaline phosphatase, creatine phosphokinase \\[CPK\\], uric acid, amylase and lipase); hematology (hemoglobin, hematocrit, red blood cell \\[RBC\\] count, white blood cell \\[WBC\\] count with differential, and platelet count); FSH (for postmenopausal women who had been amenorrheic for less than 2 years prior to screening).'}, {'measure': 'Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings', 'timeFrame': 'Baseline, Weeks 1, 4 and 12', 'description': "Criteria for potentially clinically important ECG values were defined as: PR interval \\>=300 milliseconds (msec) or \\>=25%/50% increase when baseline is \\>200 msec and ≥50% increase when baseline is less than or equal to (\\<=)200 msec; QRS interval \\>=140 msec or \\>=50% increase from baseline (IFB); QTc \\>=450 msec or \\>=30 msec increase; corrected QT interval using Fridericia's formula (QTcF) \\>=450 msec or \\>=30 msec increase."}, {'measure': 'Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)', 'timeFrame': 'Baseline up to 28 days after last study drug administration', 'description': 'An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of treatment and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-serious AEs.'}, {'measure': 'Number of Participants With Increased Fasting Blood Glucose', 'timeFrame': 'Baseline up to Week 16 (follow-up visit)'}], 'primaryOutcomes': [{'measure': 'Percent Reduction From Baseline in Urinary Albumin to Creatinine Ratio (UACR) at Week 12', 'timeFrame': 'Baseline and Week 12', 'description': 'The presence of albumin in the urine (macroalbuminuria) is a marker of kidney disease. Albumin and creatinine concentrations were obtained from spot urine samples.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in UACR at Weeks 4, 8 and 16', 'timeFrame': 'Baseline, Weeks 4, 8 and 16', 'description': 'The presence of albumin in the urine (macroalbuminuria) is a marker of kidney disease. Albumin and creatinine concentrations were obtained from spot urine samples.'}, {'measure': 'Change From Baseline in Urinary Protein to Creatinine Ratio (UPCR) at Weeks 4, 8, 12 and 16', 'timeFrame': 'Baseline, Weeks 4, 8, 12 and 16', 'description': 'The presence of protein in the urine (proteinuria) often implies kidney disease. Protein and creatinine concentrations were obtained from spot urine samples.'}, {'measure': 'Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) Using the Abbreviated Modified Diet in Renal Disease (MDRD) Formula at Weeks 1, 4, 8, 12 and 16', 'timeFrame': 'Baseline, Week 1, 4, 8, 12 and 16', 'description': 'eGFR was calculated using the MDRD equation and normalized to 1.73 m\\^2 body surface area. Age and corresponding creatinine at each visit (Weeks 1, 4, 8, 12 and 16) were used to calculate GFR'}, {'measure': 'Change From Baseline in eGFR Using Cystatin Formula at Weeks 12 and 16', 'timeFrame': 'Baseline, Week 12, and Week 16', 'description': 'Serum cystatin C may be a more reliable endogenous marker of GFR than serum creatinine. eGFR was calculated using the Cystatin Formula and normalized to 1.73 m\\^2 body surface area.'}, {'measure': 'Change From Baseline in Serum Creatinine at Weeks 1, 4, 8, 12 and 16', 'timeFrame': 'Baseline, Week 1, 4, 8, 12 and 16', 'description': 'Serum creatinine is an indicator of kidney function. Creatinine is a substance formed from the metabolism of creatine, commonly found in blood, urine, and muscle tissue. It is removed from the blood by the kidneys and excreted in urine. Normal adult blood levels of creatinine=45 to 90 micromoles per liter (mcmol/L) for females, 60 to 110 mcmol/L for males, however normal values are age-dependent. Change from baseline=creatinine level at Week 1, 4, 8, 12 or 16 minus baseline level where higher scores represented decreased kidney function.'}, {'measure': 'Change From Baseline in Serum Cystatin C at Weeks 12 and 16', 'timeFrame': 'Baseline, Week 12, and Week 16', 'description': 'Cystatin C is a protein which is mainly used as a biomarker of kidney function. If kidney function and GFR decline, the blood levels of cystatin C rise.'}, {'measure': 'Change From Baseline in Plasma Glycosylated Hemoglobin (HbA1c) at Weeks 4, 8, 12 and 16', 'timeFrame': 'Baseline, Weeks 4, 8, 12 and 16', 'description': 'HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. As the average amount of plasma glucose increases, the fraction of HbA1c increases in a predictable way.'}, {'measure': 'Summary of Plasma PF-04634817 Pharmacokinetic (PK) Concentrations at Day 1 and Weeks 1, 4, 8 and 12', 'timeFrame': '1, 2, 4 hours post-dose on Day 1; 2 hours post-dose on Weeks 1, 4, 8 and 12'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diabetic nephropathy', 'type 2 diabetes', 'albuminuria', 'chemokine antagonist'], 'conditions': ['Diabetic Nephropathy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1261007&StudyName=A%20Phase%202%20Multi-Center%20Study%20To%20Evaluate%20The%20Efficacy%20And%20Safety%20Of%20A%20Chemokine%20CCR2/5%20Receptor%20Antagonist%20In%20Adults%20With%20Type%202%20D', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The study hypothesis under test is that administration of a CCR2/5 antagonist to subjects with type 2 diabetes and overt nephropathy will result in a reduction in urinary albumin, a surrogate for improved glomerular filtration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of type 2 diabetes together with stages 2, 3a, 3b or 4 CKD, based on an eGFR of 20-75 mL/min/1.73m2.\n* Evidence of persistent, overt albuminuria; defined as a UACR \\>=300 mg/g (\\>=33.9 mg/mmol) or UPCR \\>=390 mg/g (44.1 mg/mmol), or equivalent, for 3 months or longer.\n* Stable background therapy of RAAS inhibition (ie, an ACE inhibitor and/or an ARB, which may also include an aldosterone antagonist in double RAAS but not triple RAAS inhibitor therapy) for at least 3 months before screening and to be maintained for the duration of the study.\n\nExclusion Criteria:\n\n* Subjects with CKD resulting from type 1 diabetes or non-diabetic CKD.\n* Subjects who are diagnosed with autosomal dominant polycystic kidney disease (ADPCKD), severe peripheral vascular disease (PVD) or obstructive uropathy.'}, 'identificationModule': {'nctId': 'NCT01712061', 'briefTitle': 'A Phase 2 Multi-Center Study To Evaluate The Efficacy And Safety Of A Chemokine CCR2/5 Receptor Antagonist In Adults With Type 2 Diabetes And Overt Nephropathy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multi-center Study To Evaluate The Efficacy And Safety Of Once-daily Administration Of A Chemokine Ccr2/5 Receptor Antagonist (Pf-04634817) In Adults With Type 2 Diabetes And Overt Nephropathy', 'orgStudyIdInfo': {'id': 'B1261007'}, 'secondaryIdInfos': [{'id': '2012-003332-23', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 1 PF-04634817', 'interventionNames': ['Drug: PF-04634817']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm 2 Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'PF-04634817', 'type': 'DRUG', 'description': 'Three or four tablets (50mg) daily for 12 weeks, depending on baseline renal function', 'armGroupLabels': ['Arm 1 PF-04634817']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Three or four tablets (50mg) daily for 12 weeks, depending on baseline renal function', 'armGroupLabels': ['Arm 2 Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Medical Investigations, Inc.', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '91702', 'city': 'Azusa', 'state': 'California', 'country': 'United States', 'facility': 'North America Research Institute', 'geoPoint': {'lat': 34.13362, 'lon': -117.90756}}, {'zip': '91910', 'city': 'Chula Vista', 'state': 'California', 'country': 'United States', 'facility': 'California Institute of Renal Research', 'geoPoint': {'lat': 32.64005, 'lon': -117.0842}}, {'zip': '91723', 'city': 'Covina', 'state': 'California', 'country': 'United States', 'facility': 'California Kidney Specialists', 'geoPoint': {'lat': 34.09001, 'lon': -117.89034}}, {'zip': '92648', 'city': 'Huntington Beach', 'state': 'California', 'country': 'United States', 'facility': 'Diabetes/Lipid Management and Research Center', 'geoPoint': {'lat': 33.6603, 'lon': -117.99923}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Tower Nephrology Medical Group', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '95032', 'city': 'Los Gatos', 'state': 'California', 'country': 'United States', 'facility': 'Richard S. 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