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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
Signed and dated written informed consent in accordance with International Council of Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
Male or female patients aged ≥ 18 years at time of consent.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 20 weeks.
Awards & highlights

Study 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

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You are taking any of the following medications: anti-hypertensives, NSAIDs, endothelin receptor antagonists, systemic steroids or Sodium-Glucose co-Transporter-2 (SGLT2) inhibitors.
Select...
You have Glycated Haemoglobin (HbA1c) < 10.0% at Visit 1.

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
~800

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor
2,494 Previous Clinical Trials
10,916,629 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are researchers still looking for participants in this clinical trial?

"According to the most recent update on clinicaltrials.gov, this particular trial is not looking for new patients at the moment. This study was first brought to public attention on April 27th 2021 and had its last update November 15th 2022. Although this research isn't searching for volunteers right now, there are 502 other trials that are currently looking for participants."

Answered by AI

Is this trial taking place in many hospitals across America?

"There are 26 enrolling patients for this clinical trial. For example, Meridian Clinical Research, LLC in Norfolk, Kidney and Hypertension Center in Victorville, and DaVita Clinical Research in Houston offer this study. In total, there are 26 other locations where this research is being conducted."

Answered by AI

What is the FDA's stance on BI 685509?

"While Phase 2 trials don't have the same level of data to support efficacy, BI 685509 received a score of 2 for safety because there is some clinical evidence."

Answered by AI

Who else is applying?

What state do they live in?
Texas
California
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Riverside Nephrology Physicians
~62 spots leftby Mar 2025