NCT03412006

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

A Randomized, Double-blind, Multicenter Study to Assess the Efficacy and Safety of a 6 Month Oral Treatment With the Chymase Inhibitor BAY 1142524 at a Dose of 25 mg BID in Comparison to Placebo on Top of Standard of Care in Patients With Type II Diabetes and a Clinical Diagnosis of Diabetic Kidney Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 152 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Diabetic Kidney Disease

Interventions

Type	Name	Description
DRUG	Fulacimstat (BAY1142524)	25 mg BAY1142524 are given twice daily over a treatment period of 6 months
DRUG	Placebo	Matching placebo tablets are given twice daily over a treatment period of 6 months

Timeline

• Start date: 2018-02-02
• Primary completion: 2019-10-02
• Completion: 2019-10-10
• First posted: 2018-01-26
• Last updated: 2022-03-03

Locations

27 sites across 7 countries: Bulgaria, Denmark, Finland, Israel, Italy, Spain, Sweden