check_circleStudy Completed
Diabetic Nephropathies
Bayer Identifier:
16243
ClinicalTrials.gov Identifier:
EudraCT Number:
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
BothAge
18 - N/ATrial summary
Enrollment Goal
823Trial Dates
June 2013 - August 2014Phase
Phase 2Could I Receive a placebo
YesProducts
Kerendia (Finerenone, BAY94-8862)Accepts Healthy Volunteer
NoWhere 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Withdrawn | Wien, 1090, Austria | |
Withdrawn | Wien, 1030, Austria | |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Withdrawn | Parktown, South Africa | |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 baselineAlbumin-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 potassiumdate_rangeTime Frame:Baseline and Day 90±2
- Change from baseline to Day 90 in eGFRAn 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
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
8