This International Study Tests BI 690517 in Patients With Diabetic Kidney Disease. The Study Tests How 3 Different Doses of BI 690517 Are Taken up in the Body and How Well They Are Tolerated

Summary

The primary objective of this current trial is to investigate the safety and tolerability of 3 oral doses of BI 690517 over 28 days in female and male patients with diabetic nephropathy as add-on-therapy to Angiotensin Converting Enzyme inhibitor \[ACEi\] or Angiotensin-receptor blockers \[ARB\]. Secondary objective is to evaluate the change from baseline in Urine Albumin-to-Creatinine Ratio \[UACR\].

Timeline

Start

2017-10-05

Primary completion

2020-04-16

Completion

2020-05-07

Publications

• Bornstein SR, de Zeeuw D, Heerspink HJL, Schulze F, Cronin L, Wenz A, Tuttle KR, Hadjadj S, Rossing P. Aldosterone synthase inhibitor (BI 690517) therapy for people with diabetes and albuminuric chronic kidney disease: A multicentre, randomized, double-blind, placebo-controlled, Phase I trial. Diabetes Obes Metab. 2024 Jun;26(6):2128-2138. doi: 10.1111/dom.15518. Epub 2024 Mar 18.

Drugs

Indications