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Unknown

BI 685509 for Chronic 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

Study Summary

This trial is testing a medicine called BI 685509 to see if it improves kidney function in adults with kidney disease not caused by diabetes. Placebo or one of three doses of BI 685509 is taken 3 times daily for 7 months in tablet form. Kidney function is based on analysis of urine samples and 11 visits to the study site are required.

Eligible Conditions
  • Chronic 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 UACR measured in First Morning Void urine after 20 weeks of trial treatment.
Proportion of patients achieving UACR decreases in 10-hour urine of at least 20% from baseline after 20 weeks of trial treatment.
Proportion of patients achieving UACR decreases in First Morning Void urine of at least 20% from baseline after 20 weeks of trial treatment.

Trial Design

6Treatment 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: Dose group 2: Matching placeboPlacebo Group1 Intervention
Matching placebo for low dose followed by up-titration to medium dose.
Group V: Dose group 1: Matching placeboPlacebo Group1 Intervention
Matching placebo for low dose.
Group VI: Dose group 3: Matching placeboPlacebo Group1 Intervention
Matching placebo for low dose followed by up-titration to medium dose, followed by up-titration to high dose.
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
2,499 Previous Clinical Trials
11,339,505 Total Patients Enrolled

Media Library

BI 685509 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT04736628 — Phase 2
Chronic Kidney Disease Research Study Groups: Dose group 2: BI 685509, Dose group 2: Matching placebo, Dose group 1: Matching placebo, Dose group 3: Matching placebo, Dose group 1: BI 685509, Dose group 3: BI 685509
Chronic Kidney Disease Clinical Trial 2023: BI 685509 Highlights & Side Effects. Trial Name: NCT04736628 — Phase 2
BI 685509 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04736628 — Phase 2

Frequently Asked Questions

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

Is this trial currently accepting enrollees?

"Clinicaltrials.gov suggests that this medical trial is still accepting patients; the experiment was posted on April 27, 2021 and most recently revised on November 14th 2022."

Answered by AI

What potential risks are associated with BI 685509?

"As a Phase 2 trial, BI 685509 has only demonstrated safety in clinical trials and thus is rated as 2 on our 1-3 scale."

Answered by AI

How many participants are being recruited into this research experiment?

"For the trial to run its course, Boehringer Ingelheim needs a total of 240 participants that conform to their criteria. Locations include Texas Institute for Kidney and Endocrine Disorders in Lufkin, TX and Bioclinical Research Alliance, Inc. located in Miami, FL."

Answered by AI

How many healthcare facilities are engaged in this research study?

"The medical trial has 36 sites in total, with some of the most prominent being Texas Institute for Kidney and Endocrine Disorders in Lufkin, Bioclinical Research Alliance, Inc. in Miami, and Homestead Associates in Research based out of New Iberia."

Answered by AI

Who else is applying?

What state do they live in?
Tennessee
Illinois
What site did they apply to?
Research by Design, LLC
Knoxville Kidney Center PLLC
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I’m hoping this trial will help with myCKD.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

How long does the screening process take?
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study to Test the Effect of Different Doses of BI 685509 on Kidney Function in People With Chronic Kidney Disease
2021. "A Study to Test the Effect of Different Doses of BI 685509 on Kidney Function in People With Chronic Kidney Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04736628.
~67 spots leftby Apr 2025
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