Study Completed

Diabetic Nephropathies

Bayer Identifier:

16243

ClinicalTrials.gov Identifier:

NCT01874431

EudraCT Number:

2012-004179-38

EU CT Number:

Not Available

Safety and efficacy of different oral doses of BAY94-8862 in subjects with type 2 diabetes mellitus and the clinical diagnosis of diabetic nephropathy

Trial purpose

To assess a new drug, BAY94-8862 given orally at different doses, to evaluate whether it was safe and can help the well being of patients with type 2 diabetes and diabetic nephropathy. These treatment doses were compared to placebo.

Key Participants Requirements

Sex

Both

Age

18 - N/A

Inclusion Criteria
- Men and women aged 18 years and older.The lower age limit may be higher if legally required in the participating country
- 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
Exclusion Criteria
- Non-diabetic renal disease
- 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

Trial summary

Enrollment Goal

823

Trial Dates

June 2013 - August 2014

Phase

Phase 2

Could I Receive a placebo

Yes

Products

Kerendia (Finerenone, BAY94-8862)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed		Durban, 4067, South Africa
Completed		AMIENS, 80000, France
Completed		Klipsruit West, 1812, South Africa
Completed		Somerset West, 7130, South Africa
Completed		Somerset West, 7130, South Africa
Completed		Krugersdorp, 1739, South Africa
Completed		Lenasia South, 1829, South Africa
Completed		Newtown, 2113, South Africa
Completed		Goodwood, 7460, South Africa
Completed		Durban, 4091, South Africa
Completed		Durban, 4037, South Africa
Withdrawn		Wien, 1090, Austria
Withdrawn		Wien, 1030, Austria
Completed		Wien, 1130, Austria
Completed		St. Pölten, 3100, Austria
Completed		Graz, 3086, Austria
Completed		Salzburg, 5020, Austria
Completed		Salzburg, 5026, Austria
Completed		Innsbruck, 6020, Austria
Completed		Jerez de la Frontera, 11407, Spain
Completed		Ferrol, 15405, Spain
Completed		Merebank, 4052, South Africa
Completed		Tongaat, 4400, South Africa
Completed		Cape Town, 7570, South Africa
Completed		Worcester, 6850, South Africa
Withdrawn		Parktown, South Africa
Completed		Sagunto, 46520, Spain
Completed		Madrid, 28034, Spain
Completed		Barcelona, 08025, Spain
Completed		Miami, 33015, United States
Completed		Girona, 17007, Spain
Completed		Madrid, 28041, Spain
Completed		Ålesund, 6026, Norway
Completed		Bergamo, 24020, Italy
Completed		Bergamo, 24127, Italy
Completed		Milano, 20157, Italy
Completed		Milano, 20134, Italy
Completed		Napoli, 80131, Italy
Completed		Padova, 35128, Italy
Completed		Foggia, 71013, Italy
Completed		Jerusalem, 9112001, Israel
Completed		Ashkelon, 7830604, Israel
Completed		Holon, 5822012, Israel
Completed		Tel Aviv, 6203854, Israel
Completed		Kfar Saba, 4428164, Israel
Completed		Petach Tikva, 4941492, Israel
Withdrawn		Hadera, 3810101, Israel
Withdrawn		Ramat Gan, 5262000, Israel
Completed		Stockholm, 141 86, Sweden
Completed		Stockholm, 111 57, Sweden
Completed		Stockholm, 113 24, Sweden
Completed		Vällingby, 162 68, Sweden
Completed		Flint, 48504, United States
Completed		Chula Vista, 91910, United States
Completed		Los Gatos, 95032, United States
Completed		New Haven, 06510, United States
Completed		Los Angeles, 90022, United States
Completed		Chicago, 60612, United States
Completed		Chicago, 60611, United States
Completed		Orangeburg, 29118, United States
Withdrawn		Houston, 77054, United States
Completed		Dallas, 75235-3858, United States
Completed		Burlington, 05401, United States
Completed		Flushing, 11355, United States
Completed		Birmingham, 35294, United States
Completed		Pembroke Pines, 33028, United States
Completed		Uppsala, 753 19, Sweden
Completed		Örebro, 701 85, Sweden
Completed		Karlstad, 651 85, Sweden
Completed		Skövde, 541 85, Sweden
Completed		Kristianstad, 29185, Sweden
Completed		Tel Aviv, 6937947, Israel
Completed		Hamar, 2326, Norway
Completed		Aarhus C, 8000, Denmark
Completed		Holstebro, DK-7500, Denmark
Completed		Kolding, 6000, Denmark
Completed		Gentofte, 2820, Denmark
Completed		Herlev, 2730, Denmark
Withdrawn		Køge, DK-4600, Denmark
Completed		Holbaek, 4300, Denmark
Completed		Hillerød, DK-3400, Denmark
Completed		Clayton, 3168, Australia
Completed		Box Hill, 3128, Australia
Completed		Reservoir, 3073, Australia
Completed		Oulu, 90100, Finland
Completed		Tampere, 33520, Finland
Completed		Turku, 20520, Finland
Completed		Helsinki, 00180, Finland
Completed		Jyväskylä, 40620, Finland
Completed		Cagliari, 09134, Italy
Completed		Pisa, 56124, Italy
Completed		Monza-Brianza, 20832, Italy
Completed		Prahran, 3181, Australia
Completed		Melbourne, 3052, Australia
Completed		Woolloongabba, 4102, Australia
Completed		Düsseldorf, 40210, Germany
Withdrawn		Heidelberg, 69120, Germany
Completed		Neuwied, 56564, Germany
Withdrawn		Magdeburg, 39120, Germany
Completed		Ludwigshafen, 67059, Germany
Completed		Hannover, 30625, Germany
Completed		Bad Oeynhausen, 32545, Germany
Completed		Chattanooga, 37408, United States
Completed		LYON CEDEX, 69437, France
Completed		PARIS CEDEX 15, 75908, France
Completed		LA TRONCHE, 38700, France
Completed		Seoul, 03722, Korea, Republic Of
Completed		Busan, 49241, Korea, Republic Of
Completed		Seoul, 06591, Korea, Republic Of
Completed		Taipei, 10002, Taiwan
Completed		Taipei, 11217, Taiwan
Completed		Taipei, 110, Taiwan
Completed		Kaohsiung, 833, Taiwan
Completed		Debrecen, 4032, Hungary
Completed		Eger, 3300, Hungary
Withdrawn		Budapest, 1212, Hungary
Completed		Nagykanizsa, 8800, Hungary
Completed		Papa, 8500, Hungary
Completed		Budapest, 1085, Hungary
Completed		St Leonards, 2065, Australia
Withdrawn		REIMS, 51092, France
Completed		GRONINGEN, 9713 GZ, Netherlands
Completed		HOOGEVEEN, 7909 AA, Netherlands
Completed		EINDHOVEN, 5600 PD, Netherlands
Completed		Hong Kong, Hong Kong
Completed		Shatin, Hong Kong
Completed		Lisboa, 1069-166, Portugal
Withdrawn		Coimbra, 3000-075, Portugal
Completed		Almada, 2801-951, Portugal
Completed		Lisboa, 1449-005, Portugal
Withdrawn		Faro, 8000-386, Portugal
Withdrawn		Praha 4, 140 21, Czechia
Withdrawn		Praha 4, 149 00, Czechia
Completed		Chrudim, 537 01, Czechia
Completed		Sofia, 1431, Bulgaria
Completed		Lodz, 90-153, Poland
Completed		Wroclaw, 51-162, Poland
Completed		Olawa, 55-200, Poland
Completed		Bydgoszcz, 85-822, Poland
Completed		Bialystok, 15-276, Poland
Completed		Lublin, 20-081, Poland
Completed		Warszawa, Poland
Withdrawn		Olsztyn, 10-561, Poland
Completed		Plovdiv, 4002, Bulgaria
Completed		Lukovit, 5770, Bulgaria
Completed		Haskovo, 6300, Bulgaria
Completed		Stara Zagora, 6000, Bulgaria
Completed		Varna, 9010, Bulgaria
Completed		Varna, 9000, Bulgaria
Completed		Ruse, 7003, Bulgaria
Completed		Toronto, M4C 5T2, Canada
Completed		Scarborough, M1H 3G4, Canada
Completed		Montreal, H1T 2M4, Canada
Completed		Vancouver, V5Z 1L8, Canada
Completed		Courtice, L1E 3C3, Canada
Withdrawn		Quebec, G1R 2J6, Canada
Completed		Toronto, M4N 3M5, Canada
Completed		MAASTRICHT, 6229 HX, Netherlands
Completed		AlMERE, 1311 RL, Netherlands
Completed		Kitchener, N2H 5Z8, Canada
Completed		Praha 2, 12808, Czechia
Completed		Vancouver, V6E 1M7, Canada
Withdrawn		Bilovec, 74301, Czechia
Withdrawn		Lodz, 90-647, Poland
Completed		STRASBOURG, 67091, France
Completed		Koprivnice, 742 21, Czechia
Completed		Krnov, 794 01, Czechia
Withdrawn		Lisboa, 1500-650, Portugal

Primary Outcome

Ratio of UACR at Day 90 to UACR at baseline
Albumin-to-creatinine ratio (UACR) is defined as gram of albumin per kilogram of creatinine. UACR was calculating the average of 3 first morning void samples taken on 3 consecutive days.
Time Frame:
Baseline and Day 90±2

Secondary Outcome

Change from baseline to Day 90 in serum potassium
Time Frame:
Baseline and Day 90±2
Change from baseline to Day 90 in eGFR
An estimated glomerular filtration rate (eGFR) indicates the renal function. An eGFR was calculated based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.
Time Frame:
Baseline and Day 90±2
Change from baseline to Day 90 in KDQOL-36 domain score (Effects of Kidney Disease)
The Kidney Disease QOL [KDQOL]-36 questionnaire is a specific measure of Health-Related Quality of Life (HRQoL) for chronic kidney disease (CKD) that includes effects and burden of kidney disease as well as physical and mental health scores. Index score ranges from 0 (severe problems in all items) to 100 (no problem in all items). "Effects of Kidney disease" subscore was analyzed.
Time Frame:
Baseline and Day 90±2
Change from baseline to Day 90 in EQ-5D scores (EQ5D - Visual Analog Scale)
EuroQol Group 5-Dimension, 3-Level (EQ-5D-3L) questionnaires consist of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. EQ VAS was analyzed for this endpoint and it ranges from 0 (worst possible health state) to 100 (best possible health state).
Time Frame:
Baseline and Day 90±2

Trial design

A randomized, double-blind, placebo-controlled, multi-center study to assess the safety and efficacy of different oral doses of BAY94-8862 in subjects with type 2 diabetes mellitus and the clinical diagnosis of diabetic nephropathy

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

Randomized

Blinding

Double Blind

Assignment

Parallel Assignment

Trial Arms

Additional Information

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