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Clinical Trial Details

Trial ID: L5873
Source ID: NCT01874431
Associated Drug: Finerenone (Bay94-8862)
Title: Safety and Efficacy of Different Oral Doses of BAY94-8862 in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Nephropathy
Acronym: ARTS-DN
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01874431/results
Conditions: Diabetic Nephropathies
Interventions: DRUG: Finerenone (BAY94-8862)|DRUG: Placebo
Outcome Measures: Primary: 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., Baseline and Day 90±2 | Secondary: Change From Baseline to Day 90 in Serum Potassium, 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., 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., 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)., Baseline and Day 90±2
Sponsor/Collaborators: Sponsor: Bayer
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 823
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2013-06-12
Completion Date: 2014-08-07
Results First Posted: 2021-05-04
Last Update Posted: 2021-07-01
Locations: Birmingham, Alabama, 35294, United States|Chula Vista, California, 91910, United States|Los Angeles, California, 90022, United States|Los Gatos, California, 95032, United States|New Haven, Connecticut, 06510, United States|Miami, Florida, 33015, United States|Pembroke Pines, Florida, 33028, United States|Chicago, Illinois, 60611, United States|Chicago, Illinois, 60612, United States|Flint, Michigan, 48504, United States|Flushing, New York, 11355, United States|Orangeburg, South Carolina, 29118, United States|Chattanooga, Tennessee, 37408, United States|Dallas, Texas, 75235-3858, United States|Burlington, Vermont, 05401, United States|St Leonards, New South Wales, 2065, Australia|Clayton, Victoria, 3168, Australia|Melbourne, Victoria, 3052, Australia|Prahran, Victoria, 3181, Australia|Reservoir, Victoria, 3073, Australia|Box Hill, 3128, Australia|Woolloongabba, 4102, Australia|Graz, 3086, Austria|Innsbruck, 6020, Austria|Salzburg, 5020, Austria|Salzburg, 5026, Austria|St. Pölten, 3100, Austria|Wien, 1130, Austria|Haskovo, 6300, Bulgaria|Lukovit, 5770, Bulgaria|Plovdiv, 4002, Bulgaria|Ruse, 7003, Bulgaria|Sofia, 1431, Bulgaria|Stara Zagora, 6000, Bulgaria|Varna, 9000, Bulgaria|Varna, 9010, Bulgaria|Vancouver, British Columbia, V5Z 1L8, Canada|Vancouver, British Columbia, V6E 1M7, Canada|Courtice, Ontario, L1E 3C3, Canada|Kitchener, Ontario, N2H 5Z8, Canada|Scarborough, Ontario, M1H 3G4, Canada|Toronto, Ontario, M4C 5T2, Canada|Toronto, Ontario, M4N 3M5, Canada|Montreal, Quebec, H1T 2M4, Canada|Chrudim, 537 01, Czechia|Koprivnice, 742 21, Czechia|Krnov, 794 01, Czechia|Praha 2, 12808, Czechia|Aarhus C, 8000, Denmark|Gentofte, 2820, Denmark|Herlev, 2730, Denmark|Hillerød, DK-3400, Denmark|Holbaek, 4300, Denmark|Holstebro, DK-7500, Denmark|Kolding, 6000, Denmark|Helsinki, 00180, Finland|Jyväskylä, 40620, Finland|Oulu, 90100, Finland|Tampere, 33520, Finland|Turku, 20520, Finland|Amiens, 80000, France|La Tronche, 38700, France|Lyon Cedex, 69437, France|Paris Cedex 15, 75908, France|Strasbourg, 67091, France|Hannover, Niedersachsen, 30625, Germany|Bad Oeynhausen, Nordrhein-Westfalen, 32545, Germany|Düsseldorf, Nordrhein-Westfalen, 40210, Germany|Ludwigshafen, Rheinland-Pfalz, 67059, Germany|Neuwied, Rheinland-Pfalz, 56564, Germany|Hong Kong, Hong Kong|Shatin, Hong Kong|Budapest, 1085, Hungary|Debrecen, 4032, Hungary|Eger, 3300, Hungary|Nagykanizsa, 8800, Hungary|Papa, 8500, Hungary|Ashkelon, 7830604, Israel|Holon, 5822012, Israel|Jerusalem, 9112001, Israel|Kfar Saba, 4428164, Israel|Petach Tikva, 4941492, Israel|Tel Aviv, 6203854, Israel|Tel Aviv, 6937947, Israel|Napoli, Campania, 80131, Italy|Bergamo, Lombardia, 24020, Italy|Bergamo, Lombardia, 24127, Italy|Milano, Lombardia, 20134, Italy|Milano, Lombardia, 20157, Italy|Monza-Brianza, Lombardia, 20832, Italy|Foggia, Puglia, 71013, Italy|Cagliari, Sardegna, 09134, Italy|Pisa, Toscana, 56124, Italy|Padova, Veneto, 35128, Italy|Busan, 49241, Korea, Republic of|Seoul, 03722, Korea, Republic of|Seoul, 06591, Korea, Republic of|AlMERE, 1311 RL, Netherlands|Eindhoven, 5600 PD, Netherlands|Groningen, 9713 GZ, Netherlands|Hoogeveen, 7909 AA, Netherlands|Maastricht, 6229 HX, Netherlands|Hamar, 2326, Norway|Ålesund, 6026, Norway|Bialystok, 15-276, Poland|Bydgoszcz, 85-822, Poland|Lodz, 90-153, Poland|Lublin, 20-081, Poland|Olawa, 55-200, Poland|Warszawa, Poland|Wroclaw, 51-162, Poland|Almada, 2801-951, Portugal|Lisboa, 1069-166, Portugal|Lisboa, 1449-005, Portugal|Klipsruit West, Gauteng, 1812, South Africa|Krugersdorp, Gauteng, 1739, South Africa|Lenasia South, Gauteng, 1829, South Africa|Newtown, Gauteng, 2113, South Africa|Durban, KwaZulu Natal, 4037, South Africa|Durban, KwaZulu Natal, 4091, South Africa|Durban, Kwazulu-Natal, 4067, South Africa|Merebank, Kwazulu-Natal, 4052, South Africa|Tongaat, Kwazulu-Natal, 4400, South Africa|Cape Town, Western Cape, 7570, South Africa|Goodwood, Western Cape, 7460, South Africa|Somerset West, Western Cape, 7130, South Africa|Worcester, Western Cape, 6850, South Africa|Ferrol, A Coruña, 15405, Spain|Jerez de la Frontera, Cádiz, 11407, Spain|Sagunto, Valencia, 46520, Spain|Barcelona, 08025, Spain|Girona, 17007, Spain|Madrid, 28034, Spain|Madrid, 28041, Spain|Karlstad, 651 85, Sweden|Kristianstad, 29185, Sweden|Skövde, 541 85, Sweden|Stockholm, 111 57, Sweden|Stockholm, 113 24, Sweden|Stockholm, 141 86, Sweden|Uppsala, 753 19, Sweden|Vällingby, 162 68, Sweden|Örebro, 701 85, Sweden|Kaohsiung, 833, Taiwan|Taipei, 10002, Taiwan|Taipei, 110, Taiwan|Taipei, 11217, Taiwan
URL: https://clinicaltrials.gov/show/NCT01874431

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress