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BI 685509 for Diabetic Kidney Disease

Phase 2
Waitlist Available
Research Sponsored by Boehringer Ingelheim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 20 weeks.
Awards & highlights

Summary

This trial is testing whether BI 685509 improves kidney function in adults with diabetic kidney disease. Participants are assigned to one of three doses of BI 685509 or placebo by chance, and take the medication 3 times a day for 7 months. Urine samples are collected throughout to assess kidney function, and the results are compared between groups at the end.

Eligible Conditions
  • Diabetic Kidney Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 20 weeks.
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 20 weeks. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in log transformed Urine Albumin Creatinine Ratio (UACR) measured in 10-hour urine after 20 weeks of trial treatment
Secondary outcome measures
Change from baseline in log transformed Urine Albumin Creatinine Ratio (UACR) measured in First Morning Void urine after 20 weeks of trial treatment
Number of patients achieving UACR decreases in 10-hour urine of at least 20% from baseline after 20 weeks of trial treatment
Number of patients achieving UACR decreases in First Morning Void urine of at least 20% from baseline after 20 weeks of trial treatment

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Dose group 3: BI 685509Experimental Treatment1 Intervention
Low dose followed by up-titration to medium dose, followed by up-titration to high-dose.
Group II: Dose group 2: BI 685509Experimental Treatment1 Intervention
Low dose followed by up-titration to medium dose.
Group III: Dose group 1: BI 685509Experimental Treatment1 Intervention
Low dose
Group IV: PlaceboPlacebo Group1 Intervention
This arm comprises all placebo treated participants. Participants were randomized in the dose group in a 3:1 ratio (test treatment to placebo). Participants were administered film-coated tablets of matching placebo 3 times a day during 20 weeks of treatment. The tablets were taken with water, with or without food. Patients continued the treatment until undue drug toxicity, disease progression, or withdrawal of consent, whichever occurred first.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BI 685509
2017
Completed Phase 2
~530

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor
2,516 Previous Clinical Trials
11,347,103 Total Patients Enrolled
~58 spots leftby Jul 2025
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