check_circleStudy Completed
Diabetic kidney disease
Bayer Identifier:
18933
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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
Trial purpose
The purpose of the trial is the analysis of safety and efficacy of the chymase inhibitor BAY1142524 at a dose of 25 mg BID in comparison to placebo using a 6 months treatment period in type II diabetic patients with a clinical diagnosis of diabetic kidney disease. BAY1142524 or placebo will be given on top of evidence-based standard of care for diabetic kidney disease. Primary objective is the analysis of first signs of efficacy as determined by favourable changes in urinary albumin creatinine ratio. Secondary objective is the analysis of safety and tolerability as evidenced by the incidence and severity of adverse events. 64 valid patients have to complete treatment with verum and 32 valid patients have to complete treatment with placebo.
Key Participants Requirements
Sex
AllAge
18 - 79 YearsTrial summary
Enrollment Goal
152Trial Dates
February 2018 - October 2019Phase
Phase 2Could I Receive a placebo
YesProducts
Fulacimstat (BAY1142524)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | S3 Clinical Research Centers | Vällingby, 162 68, Sweden |
Completed | Steno Diabetes Center Copenhagen | Gentofte, 2730, Denmark |
Completed | Rigshospitalet | København, 2100, Denmark |
Completed | Nordsjællands Hospital | Hillerød, 3400, Denmark |
Completed | Med Centre Diamedical 2013 | Dimitrovgrad, 6400, Bulgaria |
Completed | Med. Center Equita | Varna, 9000, Bulgaria |
Completed | MCOMH Preventsia-2000 | Stara Zagora, 6000, Bulgaria |
Completed | Terveystalo Oulu | Oulu, FI-90100, Finland |
Completed | Turun yliopistollinen keskussairaala, kantasairaala | Turku, FIN-20520, Finland |
Completed | TAYS TKI Keskus Tutkimusvastaanotto | Tampere, 33520, Finland |
Completed | Barzilai Medical Center | Ashkelon, 7830604, Israel |
Completed | Edith Wolfson Medical Center | Holon, 5822012, Israel |
Completed | A.O.U. di Padova | Padova, 35128, Italy |
Completed | IRCCS Casa Sollievo della Sofferenza | Foggia, 71013, Italy |
Completed | A.O.U. Policlinico Federico II Napoli | Napoli, 80131, Italy |
Completed | Complexo Hospitalario Universitario de Ferrol | Ferrol, 15405, Spain |
Completed | Hospital de Galdakao | Galdakao, 48960, Spain |
Completed | Hospital Fundació Puigvert | Barcelona, 08025, Spain |
Completed | Centralsjukhuset Kristianstad | Kristianstad, 29185, Sweden |
Completed | Universitetssjukhuset Örebro | Örebro, 701 85, Sweden |
Completed | Akardo MedSite AB | Stockholm, 114 46, Sweden |
Completed | DMC - Diabetes Medical Center | Tel Aviv, 6937947, Israel |
Completed | Hadassah Hebrew University Hospital Ein Kerem | Jerusalem, 9112001, Israel |
Completed | The Nazareth Trust Hospital EMMS | Nazareth, 16100, Israel |
Completed | Shamir Medical Center (Assaf Harofeh) | Zerifin, 7030000, Israel |
Completed | Pihlajalinna ITE Kuopio | Kuopio, 70100, Finland |
Completed | Univ. Alma Mater - Dip. Medicina Spec, Diagnostica e Sperim | Bologna, 40138, Italy |
Withdrawn | ASL Napoli 1 Centro | Napoli, 80138, Italy |
Primary Outcome
- 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 treatmentdate_rangeTime Frame:Baseline and at 6 months
Secondary Outcome
- Number of patients with treatment-emergent adverse eventdate_rangeTime Frame:From first intake of study drug up to 3 days after last administration of study drug
- Number of patients with serious adverse eventsdate_rangeTime Frame:From first intake of study drug up to 3 days after last administration of study drug
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
N/AAssignment
Parallel AssignmentTrial Arms
2