Safety and Efficacy of Different Oral Doses of BAY94-8862 in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Nephropathy
NCT ID: NCT01874431
Last Updated: 2021-07-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
823 participants
INTERVENTIONAL
2013-06-12
2014-08-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Finerenone (BAY94-8862) (1.25 mg)
1.25 mg dose oral once daily for 90 days
Finerenone (BAY94-8862)
Finerenone (BAY94-8862)(2.5 mg)
2.5 mg dose oral once daily for 90 days
Finerenone (BAY94-8862)
Finerenone (BAY94-8862)(5 mg)
5 mg dose oral once daily for 90 days
Finerenone (BAY94-8862)
Finerenone (BAY94-8862)(7.5 mg)
7.5 mg dose oral once daily for 90 days
Finerenone (BAY94-8862)
Finerenone (BAY94-8862) (10 mg)
10 mg dose oral once daily for 90 days
Finerenone (BAY94-8862)
Finerenone (BAY94-8862) (15 mg)
15 mg dose oral once daily for 90 days
Finerenone (BAY94-8862)
Finerenone (BAY94-8862)(20 mg)
20 mg dose oral once daily for 90 days
Finerenone (BAY94-8862)
Placebo
Placebo oral dose once daily for 90 days
Placebo
Interventions
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Finerenone (BAY94-8862)
Placebo
Eligibility Criteria
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Inclusion Criteria
* Women of childbearing potential can only be included in the study if a pregnancy test is negative and if they agree to use adequate contraception when sexually active.
* Subjects with type 2 diabetes mellitus fulfilling at least 1 of the following criteria
* are on oral antidiabetics and / or insulin,
* have a documented fasting glucose \>/= 7.0 mmol/L in the medical history,
* have a 2 hour plasma glucose \>/=11.1 mmol/L during an oral glucose tolerance test in the medical history, or
* have a glycated hemoglobin (HbA1c) \>/=6.5% \[National Glycohemoglobin Standardization Program (NGSP) / Diabetes Control and Complications Trial (DCCT)\] in the medical history or at the run-in visit
* Subjects with a clinical diagnosis of diabetic nephropathy (DN) based on at least 1 of the following criteria:
* Persistent very high albuminuria defined as urinary albumin-to-creatine ratio (UACR) of \>/=300 mg/g ( \>/= 34 mg/mmol) in 2 out of 3 first morning void samples and estimated glomerular filtration rate (eGFR) \>/=30 mL/min/1.73 m² but \< 90 mL/min/1.73m² (Chronic Kidney Disease Epidemiology Collaboration, CKD EPI) (mL = milliliter; min = minute; m2 = square meter; g = gram; mmol = millimole) or
* Persistent high albuminuria defined as UACR of \>/=30 mg/g but \<300 mg/g in (\>/=3.4mg/mmol but \<34 mg/mmol) in 2 out of 3 first morning void samples and eGFR \>/=30 mL/min/1.73 m² but \< 90 mL/min/1.73m²
* Subjects treated with an angiotensin-converting enzyme inhibitor (ACEI) and/or angiotensin receptor blocker (ARB) for at least 3 months without any adjustments to this therapy for at least 4 weeks prior to the screening visit
* Serum potassium \</= 4.8 mmol/L at both the run-in visit and the screening visit
Exclusion Criteria
* Glycated hemoglobin (HbA1c) \>12% at the run-in visit or the screening visit
* UACR \>3000 mg/g (339mg/mmol) in any of the urinary first morning void samples at the run-in visit or screening visit
* Hypertension with mean sitting systolic blood pressure (SBP) \>/=180 mmHg or mean sitting diastolic blood pressure (DBP) \>/=110 mmHg at the run-in visit or mean supine SBP \>/=160 mmHg or mean sitting DBP \>/=100 mmHg at the screening visit
* Subjects with a clinical diagnosis of heart failure with reduced ejection fraction (HFrEF) and persistent symptoms (New York Heart Association class II-IV) at the run-in visit
* Concomitant therapy with eplerenone, spironolactone, any renin inhibitor, or potassium-sparing diuretic
* Dialysis for acute renal failure within the previous 6 months prior to the run-in visit
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Birmingham, Alabama, United States
Chula Vista, California, United States
Los Angeles, California, United States
Los Gatos, California, United States
New Haven, Connecticut, United States
Miami, Florida, United States
Pembroke Pines, Florida, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Flint, Michigan, United States
Flushing, New York, United States
Orangeburg, South Carolina, United States
Chattanooga, Tennessee, United States
Dallas, Texas, United States
Burlington, Vermont, United States
St Leonards, New South Wales, Australia
Clayton, Victoria, Australia
Melbourne, Victoria, Australia
Prahran, Victoria, Australia
Reservoir, Victoria, Australia
Box Hill, , Australia
Woolloongabba, , Australia
Graz, , Austria
Innsbruck, , Austria
Salzburg, , Austria
Salzburg, , Austria
Sankt Pölten, , Austria
Vienna, , Austria
Haskovo, , Bulgaria
Lukovit, , Bulgaria
Plovdiv, , Bulgaria
Rousse, , Bulgaria
Sofia, , Bulgaria
Stara Zagora, , Bulgaria
Varna, , Bulgaria
Varna, , Bulgaria
Vancouver, British Columbia, Canada
Vancouver, British Columbia, Canada
Courtice, Ontario, Canada
Kitchener, Ontario, Canada
Scarborough Village, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Chrudim, , Czechia
Kopřivnice, , Czechia
Krnov, , Czechia
Prague, , Czechia
Aarhus C, , Denmark
Gentofte Municipality, , Denmark
Herlev, , Denmark
Hillerød, , Denmark
Holbæk, , Denmark
Holstebro, , Denmark
Kolding, , Denmark
Helsinki, , Finland
Jyväskylä, , Finland
Oulu, , Finland
Tampere, , Finland
Turku, , Finland
Amiens, , France
La Tronche, , France
Lyon, , France
Paris, , France
Strasbourg, , France
Hanover, Lower Saxony, Germany
Bad Oeynhausen, North Rhine-Westphalia, Germany
Düsseldorf, North Rhine-Westphalia, Germany
Ludwigshafen am Rhein, Rhineland-Palatinate, Germany
Neuwied, Rhineland-Palatinate, Germany
Hong Kong, , Hong Kong
Shatin, , Hong Kong
Budapest, , Hungary
Debrecen, , Hungary
Eger, , Hungary
Nagykanizsa, , Hungary
Pápa, , Hungary
Ashkelon, , Israel
Holon, , Israel
Jerusalem, , Israel
Kfar Saba, , Israel
Petah Tikva, , Israel
Tel Aviv, , Israel
Tel Aviv, , Israel
Foggia, Apulia, Italy
Napoli, Campania, Italy
Bergamo, Lombardy, Italy
Bergamo, Lombardy, Italy
Milan, Lombardy, Italy
Milan, Lombardy, Italy
Monza-Brianza, Lombardy, Italy
Cagliari, Sardinia, Italy
Pisa, Tuscany, Italy
Padua, Veneto, Italy
Almere Stad, , Netherlands
Eindhoven, , Netherlands
Groningen, , Netherlands
Hoogeveen, , Netherlands
Maastricht, , Netherlands
Ålesund, , Norway
Hamar, , Norway
Bialystok, , Poland
Bydgoszcz, , Poland
Lodz, , Poland
Lublin, , Poland
Oława, , Poland
Warsaw, , Poland
Wroclaw, , Poland
Almada, , Portugal
Lisbon, , Portugal
Lisbon, , Portugal
Klipsruit West, Gauteng, South Africa
Krugersdorp, Gauteng, South Africa
Lenasia South, Gauteng, South Africa
Newtown, Gauteng, South Africa
Durban, KwaZulu-Natal, South Africa
Durban, KwaZulu-Natal, South Africa
Durban, KwaZulu-Natal, South Africa
Merebank, KwaZulu-Natal, South Africa
Tongaat, KwaZulu-Natal, South Africa
Cape Town, Western Cape, South Africa
Goodwood, Western Cape, South Africa
Somerset West, Western Cape, South Africa
Worcester, Western Cape, South Africa
Busan, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Ferrol, A Coruña, Spain
Jerez de la Frontera, Cádiz, Spain
Sagunto, Valencia, Spain
Barcelona, , Spain
Girona, , Spain
Madrid, , Spain
Madrid, , Spain
Karlstad, , Sweden
Kristianstad, , Sweden
Örebro, , Sweden
Skövde, , Sweden
Stockholm, , Sweden
Stockholm, , Sweden
Stockholm, , Sweden
Uppsala, , Sweden
Vällingby, , Sweden
Kaohsiung City, , Taiwan
Taipei, , Taiwan
Taipei, , Taiwan
Taipei, , Taiwan
Countries
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References
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Bakris GL, Agarwal R, Chan JC, Cooper ME, Gansevoort RT, Haller H, Remuzzi G, Rossing P, Schmieder RE, Nowack C, Kolkhof P, Joseph A, Pieper A, Kimmeskamp-Kirschbaum N, Ruilope LM; Mineralocorticoid Receptor Antagonist Tolerability Study-Diabetic Nephropathy (ARTS-DN) Study Group. Effect of Finerenone on Albuminuria in Patients With Diabetic Nephropathy: A Randomized Clinical Trial. JAMA. 2015 Sep 1;314(9):884-94. doi: 10.1001/jama.2015.10081.
Snelder N, Heinig R, Drenth HJ, Joseph A, Kolkhof P, Lippert J, Garmann D, Ploeger B, Eissing T. Population Pharmacokinetic and Exposure-Response Analysis of Finerenone: Insights Based on Phase IIb Data and Simulations to Support Dose Selection for Pivotal Trials in Type 2 Diabetes with Chronic Kidney Disease. Clin Pharmacokinet. 2020 Mar;59(3):359-370. doi: 10.1007/s40262-019-00820-x.
Chung EY, Ruospo M, Natale P, Bolignano D, Navaneethan SD, Palmer SC, Strippoli GF. Aldosterone antagonists in addition to renin angiotensin system antagonists for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2020 Oct 27;10(10):CD007004. doi: 10.1002/14651858.CD007004.pub4.
Ostrominski JW, Filippatos G, Claggett BL, Miao ZM, Desai AS, Jhund PS, Henderson A, Rohwedder K, Brinker MD, Scalise A, Schloemer P, Lam CSP, Senni M, Shah SJ, Voors AA, Zannad F, Rossing P, Ruilope LM, Anker SD, Pitt B, Agarwal R, McMurray JJV, Solomon SD, Vaduganathan M. Effect of Finerenone on Morbidity and Mortality in CKD. J Am Soc Nephrol. 2025 Sep 12. doi: 10.1681/ASN.0000000823. Online ahead of print. No abstract available.
Agarwal R, Ruilope LM, Ruiz-Hurtado G, Haller H, Schmieder RE, Anker SD, Filippatos G, Pitt B, Rossing P, Lambelet M, Nowack C, Kolkhof P, Joseph A, Bakris GL. Effect of finerenone on ambulatory blood pressure in chronic kidney disease in type 2 diabetes. J Hypertens. 2023 Feb 1;41(2):295-302. doi: 10.1097/HJH.0000000000003330. Epub 2022 Dec 8.
Erraez S, Lopez-Mesa M, Gomez-Fernandez P. Mineralcorticoid receptor blockers in chronic kidney disease. Nefrologia (Engl Ed). 2021 May-Jun;41(3):258-275. doi: 10.1016/j.nefro.2020.10.001. Epub 2020 Dec 24. English, Spanish.
Related Links
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Click here to find results for studies related to Bayer Healthcare products.
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Other Identifiers
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2012-004179-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
16243
Identifier Type: -
Identifier Source: org_study_id
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