check_circleStudy 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
  • - 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
  • - 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
No

Where to participate

StatusInstitutionLocation
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.
    date_rangeTime Frame:
    Baseline and Day 90±2

Secondary Outcome

  • Change from baseline to Day 90 in serum potassium
    date_rangeTime 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.
    date_rangeTime 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.
    date_rangeTime 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).
    date_rangeTime 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
8

Additional Information

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