Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2025-12-25 @ 8:14 PM
Study NCT ID:
NCT01432535
Status:
COMPLETED
Last Update Posted:
2017-04-07
First Post:
2011-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Pharmacokinetics of Peginterferon Alfa-2b in Participants With Moderate and Severe Renal Impairment (P05655)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D051437', 'term': 'Renal Insufficiency'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C417083', 'term': 'peginterferon alfa-2b'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'The Investigator agrees not to publish or publicly present any interim results of the trial without the prior written consent of the Sponsor. The Investigator further agrees to provide review copies of abstracts or manuscripts for publication that report any results of the trial to the Sponsor 45 days prior to submission for publication or presentation. The Sponsor shall have the right to review and comment.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'One participant enrolled on the moderate renal impairment arm was later determined to be ineligible for this study arm; this participant is included in the safety analysis.', 'eventGroups': [{'id': 'EG000', 'title': 'Healthy Participants', 'description': 'Participants with normal renal function, defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m\\^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.', 'otherNumAtRisk': 12, 'otherNumAffected': 12, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Participants With Moderate Renal Impairment', 'description': 'Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m\\^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.', 'otherNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Participants With Severe Renal Impairment', 'description': 'Participants with severe renal impairment defined as having a creatinine clearance test value of \\<30 mL/min/1.73 m\\^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.', 'otherNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Feeling hot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Lymph node palpable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hypogeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Night sweats', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Thirst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'seriousEvents': [{'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Participants', 'description': 'Participants with normal renal function, defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m\\^2. 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Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.'}], 'classes': [{'categories': [{'measurements': [{'value': '305315.22', 'groupId': 'OG000', 'lowerLimit': '175840.19', 'upperLimit': '530125.58'}, {'value': '435500.38', 'groupId': 'OG001', 'lowerLimit': '248562.28', 'upperLimit': '763030.40'}, {'value': '658413.69', 'groupId': 'OG002', 'lowerLimit': '395164.74', 'upperLimit': '10907032.58'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From hour 0 (pre-dose) to 288 hours post-dose', 'description': 'AUC0-∞ is a measure of the mean concentration levels of drug in the plasma after the dose.', 'unitOfMeasure': 'pg*hr/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants with the exception of 1 moderate renal impairment participant found to be ineligible for this arm.'}, {'type': 'PRIMARY', 'title': 'AUC From Time 0 to the Last Measurable Sample (AUC0-last)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Participants', 'description': 'Participants with normal renal function, defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m\\^2. 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Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.'}], 'classes': [{'categories': [{'measurements': [{'value': '286946.43', 'groupId': 'OG000', 'lowerLimit': '164687.09', 'upperLimit': '499967.87'}, {'value': '408889.84', 'groupId': 'OG001', 'lowerLimit': '232550.52', 'upperLimit': '718944.43'}, {'value': '598863.88', 'groupId': 'OG002', 'lowerLimit': '358269.15', 'upperLimit': '1001029.37'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'From hour 0 (pre-dose) up to 288 hours post-dose', 'description': 'AUC0-last is a measure of the total amount of drug in the plasma from the dose to the last measurable sample.', 'unitOfMeasure': 'pg*hr/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants with the exception of 1 moderate renal impairment participant found to be ineligible for this arm.'}, {'type': 'PRIMARY', 'title': 'Maximum Observed Serum Concentration (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Participants', 'description': 'Participants with normal renal function, defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m\\^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.'}, {'id': 'OG001', 'title': 'Participants With Moderate Renal Impairment', 'description': 'Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m\\^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.'}, {'id': 'OG002', 'title': 'Participants With Severe Renal Impairment', 'description': 'Participants with severe renal impairment defined as having a creatinine clearance test value of \\<30 mL/min/1.73 m\\^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.'}], 'classes': [{'categories': [{'measurements': [{'value': '2547.85', 'groupId': 'OG000', 'lowerLimit': '1115.61', 'upperLimit': '5818.84'}, {'value': '3210.16', 'groupId': 'OG001', 'lowerLimit': '1386.73', 'upperLimit': '7431.24'}, {'value': '3551.03', 'groupId': 'OG002', 'lowerLimit': '1653.85', 'upperLimit': '7624.49'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'From hour 0 (pre-dose) to 288 hours post-dose', 'description': 'Cmax is a measure of the maximum amount of drug in the plasma after the dose is given.', 'unitOfMeasure': 'pg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants with the exception of 1 moderate renal impairment participant found to be ineligible for this arm.'}, {'type': 'PRIMARY', 'title': 'Time to Maximum Observed Serum Concentration (Tmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Participants', 'description': 'Participants with normal renal function, defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m\\^2. 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Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.0', 'groupId': 'OG000', 'lowerLimit': '9.0', 'upperLimit': '72.0'}, {'value': '12.0', 'groupId': 'OG001', 'lowerLimit': '12.0', 'upperLimit': '72.0'}, {'value': '60.0', 'groupId': 'OG002', 'lowerLimit': '24.0', 'upperLimit': '96.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From hour 0 (pre-dose) up to 288 hours post-dose', 'description': 'Tmax is a measure of the time to reach the maximum concentration in the plasma after the drug dose.', 'unitOfMeasure': 'hours', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants with the exception of 1 moderate renal impairment participant found to be ineligible for this arm.'}, {'type': 'PRIMARY', 'title': 'Apparent Terminal Half-life (T1/2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Participants', 'description': 'Participants with normal renal function, defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m\\^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.'}, {'id': 'OG001', 'title': 'Participants With Moderate Renal Impairment', 'description': 'Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m\\^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.'}, {'id': 'OG002', 'title': 'Participants With Severe Renal Impairment', 'description': 'Participants with severe renal impairment defined as having a creatinine clearance test value of \\<30 mL/min/1.73 m\\^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.'}], 'classes': [{'categories': [{'measurements': [{'value': '41.9', 'spread': '31.9', 'groupId': 'OG000', 'lowerLimit': '9.00', 'upperLimit': '72.00'}, {'value': '50.7', 'spread': '12.7', 'groupId': 'OG001', 'lowerLimit': '12.00', 'upperLimit': '72.00'}, {'value': '58.1', 'spread': '17.2', 'groupId': 'OG002', 'lowerLimit': '24.00', 'upperLimit': '96.30'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'From hour 0 (pre-dose) up to 288 hours post-dose', 'description': 'T1/2 is the time required for a given drug concentration in the plasma to decrease by 50%.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants with the exception of 1 moderate renal impairment participant found to be ineligible for this arm.'}, {'type': 'PRIMARY', 'title': 'Apparent Total Body Clearance (CL/F)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Participants', 'description': 'Participants with normal renal function, defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m\\^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.'}, {'id': 'OG001', 'title': 'Participants With Moderate Renal Impairment', 'description': 'Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m\\^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.'}, {'id': 'OG002', 'title': 'Participants With Severe Renal Impairment', 'description': 'Participants with severe renal impairment defined as having a creatinine clearance test value of \\<30 mL/min/1.73 m\\^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.5', 'groupId': 'OG000', 'lowerLimit': '10.42', 'upperLimit': '32.85'}, {'value': '12.72', 'groupId': 'OG001', 'lowerLimit': '7.10', 'upperLimit': '22.81'}, {'value': '8.02', 'groupId': 'OG002', 'lowerLimit': '4.71', 'upperLimit': '13.64'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From hour 0 (pre-dose) up to 288 hours post-dose', 'description': 'CL/F is a calculation of the rate at which a drug is removed from the body via renal, hepatic and other clearance pathways, expressed as volume (milliliters) per unit of time (minutes).', 'unitOfMeasure': 'mL/min', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants with the exception of 1 moderate renal impairment participant found to be ineligible for this arm.'}, {'type': 'PRIMARY', 'title': 'Apparent Volume of Distribution (Vd/F)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Participants', 'description': 'Participants with normal renal function, defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m\\^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.'}, {'id': 'OG001', 'title': 'Participants With Moderate Renal Impairment', 'description': 'Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m\\^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.'}, {'id': 'OG002', 'title': 'Participants With Severe Renal Impairment', 'description': 'Participants with severe renal impairment defined as having a creatinine clearance test value of \\<30 mL/min/1.73 m\\^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.'}], 'classes': [{'categories': [{'measurements': [{'value': '90.63', 'groupId': 'OG000', 'lowerLimit': '41.76', 'upperLimit': '196.69'}, {'value': '72.26', 'groupId': 'OG001', 'lowerLimit': '32.88', 'upperLimit': '158.82'}, {'value': '55.90', 'groupId': 'OG002', 'lowerLimit': '27.30', 'upperLimit': '114.49'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'From hour 0 (pre-dose) up to 288 hours post-dose', 'description': 'Vd/F is defined as the distribution of a medication between the plasma and the rest of the body after the dose. It is the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of the drug.', 'unitOfMeasure': 'Liters', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants with the exception of 1 moderate renal impairment participant found to be ineligible for this arm.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Healthy Participants', 'description': 'Participants with normal renal function, defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m\\^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.'}, {'id': 'FG001', 'title': 'Participants With Moderate Renal Impairment', 'description': 'Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m\\^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.'}, {'id': 'FG002', 'title': 'Participants With Severe Renal Impairment', 'description': 'Participants with severe renal impairment defined as having a creatinine clearance test value of \\<30 mL/min/1.73 m\\^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'comment': 'One participant later determined ineligible is not included in baseline/efficacy analyses.', 'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Healthy Participants', 'description': 'Participants with normal renal function, defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m\\^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.'}, {'id': 'BG001', 'title': 'Participants With Moderate Renal Impairment', 'description': 'Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m\\^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.'}, {'id': 'BG002', 'title': 'Participants With Severe Renal Impairment', 'description': 'Participants with severe renal impairment defined as having a creatinine clearance test value of \\<30 mL/min/1.73 m\\^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.33', 'spread': '9.63', 'groupId': 'BG000'}, {'value': '64.00', 'spread': '6.23', 'groupId': 'BG001'}, {'value': '52.67', 'spread': '12.74', 'groupId': 'BG002'}, {'value': '57.83', 'spread': '10.25', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-09', 'studyFirstSubmitDate': '2011-09-09', 'resultsFirstSubmitDate': '2013-07-23', 'studyFirstSubmitQcDate': '2011-09-09', 'lastUpdatePostDateStruct': {'date': '2017-04-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-07-23', 'studyFirstPostDateStruct': {'date': '2011-09-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞)', 'timeFrame': 'From hour 0 (pre-dose) to 288 hours post-dose', 'description': 'AUC0-∞ is a measure of the mean concentration levels of drug in the plasma after the dose.'}, {'measure': 'AUC From Time 0 to the Last Measurable Sample (AUC0-last)', 'timeFrame': 'From hour 0 (pre-dose) up to 288 hours post-dose', 'description': 'AUC0-last is a measure of the total amount of drug in the plasma from the dose to the last measurable sample.'}, {'measure': 'Maximum Observed Serum Concentration (Cmax)', 'timeFrame': 'From hour 0 (pre-dose) to 288 hours post-dose', 'description': 'Cmax is a measure of the maximum amount of drug in the plasma after the dose is given.'}, {'measure': 'Time to Maximum Observed Serum Concentration (Tmax)', 'timeFrame': 'From hour 0 (pre-dose) up to 288 hours post-dose', 'description': 'Tmax is a measure of the time to reach the maximum concentration in the plasma after the drug dose.'}, {'measure': 'Apparent Terminal Half-life (T1/2)', 'timeFrame': 'From hour 0 (pre-dose) up to 288 hours post-dose', 'description': 'T1/2 is the time required for a given drug concentration in the plasma to decrease by 50%.'}, {'measure': 'Apparent Total Body Clearance (CL/F)', 'timeFrame': 'From hour 0 (pre-dose) up to 288 hours post-dose', 'description': 'CL/F is a calculation of the rate at which a drug is removed from the body via renal, hepatic and other clearance pathways, expressed as volume (milliliters) per unit of time (minutes).'}, {'measure': 'Apparent Volume of Distribution (Vd/F)', 'timeFrame': 'From hour 0 (pre-dose) up to 288 hours post-dose', 'description': 'Vd/F is defined as the distribution of a medication between the plasma and the rest of the body after the dose. It is the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of the drug.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Renal Insufficiency']}, 'descriptionModule': {'briefSummary': 'This study will compare the pharmacokinetics of a single dose of peginterferon alfa-2b (Sylatron®) in healthy participants to that in participants with moderate to severe impairment of kidney function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Body Mass Index (BMI) between 19 to 40 kg/m\\^2, inclusive\n* Moderate renal impairment and severe renal impairment and/or end-stage renal disease (ESRD) who may require hemodialysis and normal renal function\n* Free of any clinically significant disease (except those related to renal disease and comorbid conditions) that requires a physician's care and would interfere with the study\n* Females of reproductive potential must have used a medically accepted method of contraception for three months prior to screening and must agree to use an accepted contraceptive method during and for two months following the study\n* Males must agree to use a medically accepted method of contraception during the trial and for 3 months after the study\n\nExclusion Criteria:\n\n* Pregnant, intend to become pregnant, or breastfeeding\n* Surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug\n* History of any infectious disease within 4 weeks prior to study drug administration that affects ability to participate in the study\n* Positive for hepatitis B surface antigen, and/or for human immunodeficiency virus (HIV) antibodies. Healthy participants positive for hepatitis C antibodies\n* Previously received PegIntron®, Sylatron®, and/or Pegasys\n* More than 10 cigarettes or equivalent tobacco use per day\n* History of malignancy\n* Hypothyroidism or hyperthyroidism\n* History of depression requiring treatment with psychotherapy or medication\n* History of suicidality or at risk of self-harm or harm to others\n* History of autoimmune disorder requiring medical therapy\n* Immune mediated renal insufficiency\n* Removal of a kidney (healthy participants) or functioning renal transplant (participants with renal impairment)"}, 'identificationModule': {'nctId': 'NCT01432535', 'briefTitle': 'Pharmacokinetics of Peginterferon Alfa-2b in Participants With Moderate and Severe Renal Impairment (P05655)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Single Dose Study to Assess Pharmacokinetics of SCH 54031 in Patients With Renal Impairment (P05655)', 'orgStudyIdInfo': {'id': 'P05655'}, 'secondaryIdInfos': [{'id': 'MK-4031-350', 'type': 'OTHER', 'domain': 'Merck protocol number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy Participants', 'description': 'Participants with normal renal function defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m\\^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.', 'interventionNames': ['Drug: PegIFN-2b (Sylatron®)']}, {'type': 'EXPERIMENTAL', 'label': 'Participants with Moderate Renal Impairment', 'description': 'Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m\\^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.', 'interventionNames': ['Drug: PegIFN-2b (Sylatron®)']}, {'type': 'EXPERIMENTAL', 'label': 'Participants with Severe Renal Impairment', 'description': 'Participants with severe renal impairment defined as having a creatinine clearance test value of \\<30 mL/min/1.73 m\\^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.', 'interventionNames': ['Drug: PegIFN-2b (Sylatron®)']}], 'interventions': [{'name': 'PegIFN-2b (Sylatron®)', 'type': 'DRUG', 'otherNames': ['PegIntron®', 'Peginterferon alfa-2b', 'SCH 054031', 'MK-4031'], 'description': 'Single 4.5 μg/kg dose', 'armGroupLabels': ['Healthy Participants', 'Participants with Moderate Renal Impairment', 'Participants with Severe Renal Impairment']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\\_Updated%20July\\_9\\_2014.pdf\n\nhttp://engagezone.msd.com/ds\\_documentation.php'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}