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Clinical Trial Details

Trial ID: L6140
Source ID: NCT03412006
Associated Drug: Fulacimstat (Bay1142524)
Title: A Double-blind Study to Investigate Efficacy, Safety and Tolerability of BAY1142524 in Patients With Type II Diabetes and a Clinical Diagnosis of Diabetic Kidney Disease
Acronym: CADA DIA
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetic Kidney Disease
Interventions: DRUG: Fulacimstat (BAY1142524)|DRUG: Placebo
Outcome Measures: Primary: Change in urinary albumin to creatinine ratio (UACR), The ratio of albumin to creatinin will be determined in first morning void urine at baseline (before treatment start) and after 6 months of treatment, Baseline and at 6 months | Secondary: Number of patients with treatment-emergent adverse event, From first intake of study drug up to 3 days after last administration of study drug|Number of patients with serious adverse events, From first intake of study drug up to 3 days after last administration of study drug
Sponsor/Collaborators: Sponsor: Bayer
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 152
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2018-02-02
Completion Date: 2019-10-10
Results First Posted:
Last Update Posted: 2022-03-03
Locations: Med Centre Diamedical 2013, Dimitrovgrad, 6400, Bulgaria|MCOMH Preventsia-2000, Stara Zagora, 6000, Bulgaria|Med. Center Equita, Varna, 9000, Bulgaria|Steno Diabetes Center Copenhagen, Gentofte, 2730, Denmark|Nordsjællands Hospital, Hillerød, 3400, Denmark|Rigshospitalet, København, 2100, Denmark|Pihlajalinna ITE Kuopio, Kuopio, 70100, Finland|Terveystalo Oulu, Oulu, FI-90100, Finland|TAYS TKI Keskus Tutkimusvastaanotto, Tampere, 33520, Finland|Turun yliopistollinen keskussairaala, kantasairaala, Turku, FIN-20520, Finland|Barzilai Medical Center, Ashkelon, 7830604, Israel|Edith Wolfson Medical Center, Holon, 5822012, Israel|Hadassah Hebrew University Hospital Ein Kerem, Jerusalem, 9112001, Israel|The Nazareth Trust Hospital EMMS, Nazareth, 16100, Israel|DMC - Diabetes Medical Center, Tel Aviv, 6937947, Israel|Shamir Medical Center (Assaf Harofeh), Zerifin, 7030000, Israel|A.O.U. Policlinico Federico II Napoli, Napoli, Campania, 80131, Italy|Univ. Alma Mater - Dip. Medicina Spec, Diagnostica e Sperim, Bologna, Emilia-Romagna, 40138, Italy|IRCCS Casa Sollievo della Sofferenza, Foggia, Puglia, 71013, Italy|A.O.U. di Padova, Padova, Veneto, 35128, Italy|Complexo Hospitalario Universitario de Ferrol, Ferrol, A Coruña, 15405, Spain|Hospital de Galdakao, Galdakao, Vizcaya, 48960, Spain|Hospital Fundació Puigvert, Barcelona, 08025, Spain|Centralsjukhuset Kristianstad, Kristianstad, 29185, Sweden|Akardo MedSite AB, Stockholm, 114 46, Sweden|S3 Clinical Research Centers, Vällingby, 162 68, Sweden|Universitetssjukhuset Örebro, Örebro, 701 85, Sweden
URL: https://clinicaltrials.gov/show/NCT03412006

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress