drugset / Trial / NCT03165227

This Study Tests a New Medicine Called BI 685509 in Patients That Have Kidney Problems Because of Diabetes. The Study Tests How BI 685509 is Taken up in the Body and How Well it is Tolerated (Multiple Rising Doses)

NCT03165227

Phase 1 Completed 75 enrolled Boehringer Ingelheim
RandomizedSequentialDouble-blindTreatment

Summary

The main objective of this trial is the safety and tolerability of 3 multiple rising oral doses of BI 685509 over 28 days in male and female patients with Diabetic Nephropathy (DN) as adjunctive to Angiotensin Converting Enzyme inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB). Another objective is the change in Urine Albumin Creatinine Ratio (UACR), an important diagnostic marker of nephropathy.

Timeline

Start
2017-10-17
Primary completion
2019-12-10
Completion
2019-12-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Avenciguat Small molecule Oral