Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-26 @ 2:33 AM
Study NCT ID:
NCT05254002
Status:
COMPLETED
Last Update Posted:
2025-03-18
First Post:
2022-02-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Learn How Well the Treatment Combination of Finerenone and Empagliflozin Works and How Safe it is Compared to Each Treatment Alone in Adult Participants With Long-term Kidney Disease (Chronic Kidney Disease) and Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'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': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C576501', 'term': 'finerenone'}, {'id': 'C570240', 'term': 'empagliflozin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1664}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-03-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-17', 'studyFirstSubmitDate': '2022-02-04', 'studyFirstSubmitQcDate': '2022-02-23', 'lastUpdatePostDateStruct': {'date': '2025-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relative change from baseline in UACR at 180 days in combination therapy group versus empagliflozin alone', 'timeFrame': 'Up to 180 days', 'description': 'Urinary albumin to-creatinine ratio (UACR)'}, {'measure': 'Relative change from baseline in UACR at 180 days in combination therapy group versus finerenone alone', 'timeFrame': 'Up to 180 days'}, {'measure': 'Mean ratio of change from baseline to Day 180 in UACR for the combination therapy group, to empagliflozin alone', 'timeFrame': 'Upto 180 days'}, {'measure': 'Mean ratio of change from baseline to Day 180 in UACR for the combination therapy group, to finerenone alone', 'timeFrame': 'Up to 180 days'}], 'secondaryOutcomes': [{'measure': 'Relative change in UACR between end of treatment visit (Day 180) and 30 days after end of treatment visit (Day 210)', 'timeFrame': 'Up to 210 days'}, {'measure': 'Relative change in UACR between 30 days after end of treatment visit (Day 210) and baseline (Day 1)', 'timeFrame': 'Up to 210 days'}, {'measure': 'Relative change in UACR category (>30%, >40%, >50%) at 180 days', 'timeFrame': 'Up to 180 days'}, {'measure': 'Ratio of change from baseline in eGFR at 30 days', 'timeFrame': 'Up to 30 days', 'description': 'estimated glomerular filtration rate (eGRF)'}, {'measure': 'eGFR decline greater than 30% at 30 days from baseline', 'timeFrame': 'Up to 30 days'}, {'measure': 'Ratio of change in eGFR at 180 days and 210 days from Day 30', 'timeFrame': 'Up to 210 days'}, {'measure': 'Proportion of participants with of acute kidney injury (AKI) events', 'timeFrame': 'Up to 180 days', 'description': 'AKI is defined as any of the following:\n\n* An increase in serum creatinine by greater than or equal to 0.3 mg/dL within 48 hours; or\n* An increase in serum creatinine by greater than or equal to 1.5 times baseline, which is known or presumed to have occurred within the prior 7 days; or\n* A urine volume less than 0.5 ml/kg/h for 6 hours'}, {'measure': 'Total number of AKI events', 'timeFrame': 'Up to 180 days'}, {'measure': 'Proportion of participants with hyperkalemia events (moderate hyperkalemia [5.5 <K+ ≤6.0 mmol/L], severe hyperkalemia [K+ >6.0 mmol/L])', 'timeFrame': 'Up to 180 days', 'description': 'serum/plasma potassium (k+)'}, {'measure': 'Total number of hyperkalemia events (moderate hyperkalemia [5.5 <K+ ≤6.0 mmol/L], severe hyperkalemia [K+ >6.0 mmol/L])', 'timeFrame': 'Up to 180 days'}, {'measure': 'Change from baseline in K+', 'timeFrame': 'Up to 180 days'}, {'measure': 'Proportion of participants with severe hypoglycemia events', 'timeFrame': 'Up to 180 days', 'description': 'Severe hypoglycemia is defined as glucose level of \\<3.0 mmol/L (\\<54 mg/dL).'}, {'measure': 'Total number of events of severe hypoglycemia events', 'timeFrame': 'Up to 180 days'}, {'measure': 'Proportion of participants with symptomatic hypotension events', 'timeFrame': 'Up to 180 days'}, {'measure': 'Total number of symptomatic hypotension events', 'timeFrame': 'Up to 180 days'}, {'measure': 'Proportion of participants with genital mycotic events', 'timeFrame': 'Up to 180 days'}, {'measure': 'Total number of genital mycotic events', 'timeFrame': 'Up to 180 days'}, {'measure': 'Proportion of participants with ketoacidosis events', 'timeFrame': 'Up to 180 days'}, {'measure': 'Total number of ketoacidosis events', 'timeFrame': 'Up to 180 days'}, {'measure': 'Proportion of participants with necrotizing fasciitis of the perineum events', 'timeFrame': 'Up to 180 days'}, {'measure': 'Total number of necrotizing fasciitis of the perineum events', 'timeFrame': 'Up to 180 days'}, {'measure': 'Proportion of participants with urosepsis and pyelonephritis events', 'timeFrame': 'Up to 180 days'}, {'measure': 'Total number of urosepsis and pyelonephritis events', 'timeFrame': 'Up to 180 days'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus', 'Chronic Kidney Disease']}, 'referencesModule': {'references': [{'pmid': '40965042', 'type': 'DERIVED', 'citation': 'Agarwal R, Green JB, Heerspink HJL, Mann JFE, McGill JB, Mottl A, Osonoi T, Pal A, Rossing P, Rosenstock J, Vaduganathan M, Li L, Li N, Scott C, Manjrekar P, Yamashita S, Nangaku M. Impact of Simultaneous Initiation of Finerenone and Empagliflozin on Urinary Albumin-to-Creatinine Ratio in Asia: Pre-Specified Analysis of CONFIDENCE. Clin J Am Soc Nephrol. 2025 Sep 18. doi: 10.2215/CJN.0000000865. Online ahead of print. No abstract available.'}, {'pmid': '40886054', 'type': 'DERIVED', 'citation': 'Vaduganathan M, Green JB, Heerspink HJL, Kim SG, Mann JFE, McGill JB, Mottl A, Nangaku M, Rosenstock J, Rossing P, Li L, Li N, Rohwedder K, Scott C, Agarwal R. Simultaneous initiation of finerenone and empagliflozin across the spectrum of kidney risk in the CONFIDENCE trial. Nephrol Dial Transplant. 2025 Aug 31:gfaf160. doi: 10.1093/ndt/gfaf160. Online ahead of print.'}, {'pmid': '40470996', 'type': 'DERIVED', 'citation': 'Agarwal R, Green JB, Heerspink HJL, Mann JFE, McGill JB, Mottl AK, Rosenstock J, Rossing P, Vaduganathan M, Brinker M, Edfors R, Li N, Scheerer MF, Scott C, Nangaku M; CONFIDENCE Investigators. Finerenone with Empagliflozin in Chronic Kidney Disease and Type 2 Diabetes. N Engl J Med. 2025 Aug 7;393(6):533-543. doi: 10.1056/NEJMoa2410659. Epub 2025 Jun 5.'}, {'pmid': '39916475', 'type': 'DERIVED', 'citation': 'Agarwal R, Green JB, Heerspink HJL, Mann JFE, McGill JB, Mottl AK, Rosenstock J, Rossing P, Vaduganathan M, Brinker M, Edfors R, Li N, Scheerer MF, Scott C, Nangaku M; CONFIDENCE investigators. COmbinatioN effect of FInerenone anD EmpaglifloziN in participants with chronic kidney disease and type 2 diabetes using a UACR Endpoint (CONFIDENCE) trial: baseline clinical characteristics. Nephrol Dial Transplant. 2025 Aug 1;40(8):1559-1569. doi: 10.1093/ndt/gfaf022.'}, {'pmid': '39078403', 'type': 'DERIVED', 'citation': 'Rossing P. Experimental Designs for Multicomponent Interventions in Kidney and Cardiometabolic Diseases. J Am Soc Nephrol. 2024 Oct 1;35(10):1438-1441. doi: 10.1681/ASN.0000000000000449. Epub 2024 Jul 5. No abstract available.'}, {'pmid': '39037799', 'type': 'DERIVED', 'citation': 'Zachariah T, Radhakrishnan J. Potential Role of Mineralocorticoid Receptor Antagonists in Nondiabetic Chronic Kidney Disease and Glomerular Disease. Clin J Am Soc Nephrol. 2024 Nov 1;19(11):1499-1512. doi: 10.2215/CJN.0000000000000540. Epub 2024 Jul 22.'}], 'seeAlsoLinks': [{'url': 'https://clinicaltrials.bayer.com/study/21839', 'label': 'Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.'}]}, 'descriptionModule': {'briefSummary': "Finerenone works by blocking a group of proteins, called mineralocorticoid receptor. An increased stimulation of mineralocorticoid receptor is known to trigger injury and inflammation in the kidney and is therefore thought to play a role in CKD.\n\nEmpagliflozin lowers blood sugar levels by increasing the excretion of glucose from the blood into the urine.\n\nIn this study, the researchers want to learn how well the combination of finerenone and empagliflozin helps to slow down the worsening of the participants' kidney function compared to either treatment alone. For this, the level of protein in the urine will be measured. The investigators also want to know how safe the combination is compared to either treatment alone.\n\nDepending on the treatment group, the participants will either take the combination of finerenone and empagliflozin, or finerenone together with a placebo, or empagliflozin together with a placebo, once a day as tablets by mouth. A placebo looks like a treatment but does not have any medicine in it. Importantly, the participants will also continue to take their other current medicine for CKD and T2D.\n\nThe participants will be in the study for up to 7.5 months and will take the study treatments for 6 months. During the study, participants will visit the study site 7 times.\n\nThe study team will:\n\n* collect blood and urine samples\n* check the participants' vital signs\n* do a physical examination including height and weight\n* check the participants' heart health by using an electrocardiogram (ECG)\n* monitor the participants' blood pressure\n* ask the participants questions about how they are feeling and what adverse events they may be having An adverse event is any problem that happens during the trial. Doctors keep track of all events that happen in trials, even if they do not think the events might be related to the study treatments."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participant with a clinical diagnosis of chronic kidney disease (CKD) and the following:\n\n * In Part A: eGFR 40-90 ml/min/1.73m\\^2 (with no more than 20% having an eGFR \\>75 ml/min/1.73m\\^2) using Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) formula at screening visit and at least one historical value of eGFR \\<60 mL/min/1.73 m\\^2 within 3 months or have a registered diagnosis of CKD.\n * In Part B: eGFR 30-90 ml/min/1.73m\\^2 (with no more than 20% having an eGFR \\>75 ml/min/1.73m\\^2) using CKD-EPI formula at screening visit and at least one historical value of eGFR \\<60 mL/min/1.73 m\\^2 within 3 months or have a registered diagnostic of CKD.\n * 100 ≤UACR \\<5000 mg/g at screening visit (mean value from 3 morning void samples) and documentation of albuminuria/proteinuria (quantitative or semi-quantitative measurement) in the participant's medical records at least 3 months prior to screening\n* Participant with type 2 diabetes (T2D) as defined by the American Diabetes Association (ADA 2021), with glycated hemoglobin (HbA1c) at screening \\<11%.\n* Participant treated with the clinically maximum tolerated dose, as per investigator judgment, of angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB), but not both, for more than 1 month at screening visit.\n\nExclusion Criteria:\n\n* Participants with type 1 diabetes (T1D).\n* Participant with hepatic insufficiency classified as Child-Pugh C.\n* Participant with blood pressure at Day 1 visit (Visit 2) higher than 160 systolic blood pressure (SBP) or 100 diastolic blood pressure (DBP) or SBP lower than 90 mmHg.\n* Participant currently treated with a sodium/glucose cotransporter-2 inhibitor (SGLT2i) or SGLT-1/2i or who received a SGLT2i or SGLT-1/2i which cannot be discontinued at least 8 weeks prior to the screening visit and during study intervention treatment.\n* Participant treated with another mineralocorticoid receptor antagonist (MRA) (e.g., eplerenone, esaxerenone, spironolactone, canrenone), a renin inhibitor, potassium supplements, a potassium sparing diuretic (e.g., amiloride, triamterene), a potassium binder agent, or angiotensin receptor-neprilysin inhibitor (ARNI) which cannot be discontinued at least 8 weeks prior to the screening visit and during study intervention treatment.\n* Participants currently treated or who were treated with Finerenone (Kerendia©) within 8 weeks prior to the screening visit.\n* Participant with serum/plasma potassium (K+) above 4.8 mmol/L at screening visit (central laboratory value)."}, 'identificationModule': {'nctId': 'NCT05254002', 'acronym': 'CONFIDENCE', 'briefTitle': 'A Study to Learn How Well the Treatment Combination of Finerenone and Empagliflozin Works and How Safe it is Compared to Each Treatment Alone in Adult Participants With Long-term Kidney Disease (Chronic Kidney Disease) and Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'A Parallel-group Treatment, Phase 2, Double-blind, Three-arm Study to Assess Efficacy and Safety of Finerenone Plus Empagliflozin Compared With Either Finerenone or Empagliflozin Alone in Participants With Chronic Kidney Disease and Type 2 Diabetes.', 'orgStudyIdInfo': {'id': '21839'}, 'secondaryIdInfos': [{'id': '2023-506981-30-00', 'type': 'REGISTRY', 'domain': 'CTIS'}, {'id': '2021-003037-11', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Finerenone and Empagliflozin', 'description': 'Participants will take Finerenone (10 or 20 mg once daily \\[OD\\]) and Empagliflozin (10 mg OD) for up to 180 days.', 'interventionNames': ['Drug: Finerenone (BAY94-8862 ) 10 mg', 'Drug: Empagliflozin', 'Drug: Finerenone (BAY94-8862 ) 20 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Finerenone and Empagliflozin placebo', 'description': 'Participants will take Finerenone (10 or 20 mg OD) and matching placebo to Empagliflozin (OD) for up to 180 days.', 'interventionNames': ['Drug: Finerenone (BAY94-8862 ) 10 mg', 'Drug: Empagliflozin Placebo', 'Drug: Finerenone (BAY94-8862 ) 20 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Empagliflozin and Finerenone placebo', 'description': 'Participants will take Empagliflozin (10 mg OD) and matching placebo to Finerenone (OD). for up to 180 days.', 'interventionNames': ['Drug: Empagliflozin', 'Drug: Finerenone Placebo']}], 'interventions': [{'name': 'Finerenone (BAY94-8862 ) 10 mg', 'type': 'DRUG', 'description': 'oral administration, once daily if screening eGFR (Estimated glomerular filtration rate) results are: \\<60 mL/min/1.73 m2', 'armGroupLabels': ['Finerenone and Empagliflozin', 'Finerenone and Empagliflozin placebo']}, {'name': 'Empagliflozin', 'type': 'DRUG', 'description': 'oral administration, once daily', 'armGroupLabels': ['Empagliflozin and Finerenone placebo', 'Finerenone and Empagliflozin']}, {'name': 'Empagliflozin Placebo', 'type': 'DRUG', 'description': 'Matching placebo to empagliflozin oral administration, once daily', 'armGroupLabels': ['Finerenone and Empagliflozin placebo']}, {'name': 'Finerenone (BAY94-8862 ) 20 mg', 'type': 'DRUG', 'description': 'oral administration, once daily if screening eGFR (Estimated glomerular filtration rate) results are: ≥60 mL/min/1.73 m2', 'armGroupLabels': ['Finerenone and Empagliflozin', 'Finerenone and Empagliflozin placebo']}, {'name': 'Finerenone Placebo', 'type': 'DRUG', 'description': 'Matching Placebo to Finerenone oral administration once daily', 'armGroupLabels': ['Empagliflozin and Finerenone placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85374', 'city': 'Surprise', 'state': 'Arizona', 'country': 'United States', 'facility': 'Southwest Kidney Institute, PLC', 'geoPoint': {'lat': 33.63059, 'lon': -112.33322}}, {'zip': '90022', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Academic Medical Research Institute', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '91325', 'city': 'Northridge', 'state': 'California', 'country': 'United States', 'facility': 'Northridge Hospital', 'geoPoint': {'lat': 34.22834, 'lon': -118.53675}}, {'zip': '91342-1437', 'city': 'Sylmar', 'state': 'California', 'country': 'United States', 'facility': 'Olive View - UCLA Medical Center', 'geoPoint': {'lat': 34.30778, 'lon': -118.44925}}, {'zip': '94592', 'city': 'Vallejo', 'state': 'California', 'country': 'United States', 'facility': 'Touro University California', 'geoPoint': {'lat': 38.10409, 'lon': -122.25664}}, {'zip': '06708', 'city': 'Waterbury', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Chase Medical Research, LLC', 'geoPoint': {'lat': 41.55815, 'lon': -73.0515}}, {'zip': '33445', 'city': 'Delray Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Kidney Physicians - Delray Beach Nephrology', 'geoPoint': {'lat': 26.46146, 'lon': -80.07282}}, {'zip': '34761-4547', 'city': 'Ocoee', 'state': 'Florida', 'country': 'United States', 'facility': 'West Orange Endocrinology & Clinical Research', 'geoPoint': {'lat': 28.56917, 'lon': -81.54396}}, {'zip': '33952', 'city': 'Port Charlotte', 'state': 'Florida', 'country': 'United States', 'facility': 'Innovative Research Institute', 'geoPoint': {'lat': 26.97617, 'lon': -82.09064}}, {'zip': '33401-3430', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Metabolic Research Institute, Inc.', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '30303', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Grady Memorial Hospital - Endocrinology', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30344', 'city': 'East Point', 'state': 'Georgia', 'country': 'United States', 'facility': 'Southeast Kidney Associates', 'geoPoint': {'lat': 33.67955, 'lon': -84.43937}}, {'zip': '31406', 'city': 'Savannah', 'state': 'Georgia', 'country': 'United States', 'facility': 'Velocity Clinical Research - Savannah', 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'zip': '40383', 'city': 'Versailles', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Versailles Family Medicine', 'geoPoint': {'lat': 38.05258, 'lon': -84.72995}}, {'zip': '70006', 'city': 'Metairie', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Nola Care Clinical Research', 'geoPoint': {'lat': 29.98409, 'lon': -90.15285}}, {'zip': '70006', 'city': 'Metairie', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Omega Clinical Research Center', 'geoPoint': {'lat': 29.98409, 'lon': -90.15285}}, {'zip': '02360', 'city': 'Plymouth', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'South Shore Nephrology', 'geoPoint': {'lat': 41.95844, 'lon': -70.66726}}, {'zip': '49085', 'city': 'Saint Joseph', 'state': 'Michigan', 'country': 'United States', 'facility': 'Lake Michigan Nephrology', 'geoPoint': {'lat': 42.10976, 'lon': -86.48002}}, {'zip': '64111', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Clinical Research Consultants', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '64128', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Kansas City VA Medical Center - Endocrinology', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '63110-1010', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine in St. Louis', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '63136', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'St. Louis Heart & Vascular, PC', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '68510', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Somnos Clinical Research', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '68701', 'city': 'Norfolk', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Meridian Clinical Research- Norfolk', 'geoPoint': {'lat': 42.02834, 'lon': -97.417}}, {'zip': '89102', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Healor Primary Care / CCT Research', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '89119', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Santa Rosa Medical Centers of Nevada / CCT Research', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '10941', 'city': 'Middletown', 'state': 'New York', 'country': 'United States', 'facility': 'Circuit Clinical/Crystal Run', 'geoPoint': {'lat': 41.44593, 'lon': -74.42293}}, {'zip': '27203', 'city': 'Asheboro', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Randolph Medical Associates', 'geoPoint': {'lat': 35.70791, 'lon': -79.81364}}, {'zip': '27599-7155', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina Kidney Center', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '27834', 'city': 'Greenville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Eastern Nephrology Associates - Greenville West', 'geoPoint': {'lat': 35.61266, 'lon': -77.36635}}, {'zip': '28792', 'city': 'Hendersonville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Blue Sky, MD/ Lamond Family Medicine', 'geoPoint': {'lat': 35.31873, 'lon': -82.46095}}, {'zip': '28504', 'city': 'Kinston', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Eastern Nephrology Associates - Kinston', 'geoPoint': {'lat': 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This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.\n\nInterested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}