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NCT04750577 · ClinicalTrials.gov registry record · Phase 2

A Study to Test the Effect of Different Doses of BI 685509 on Kidney Function in People With Diabetic Kidney Disease

A Phase 2 study of Diabetic Nephropathies, sponsored by Boehringer Ingelheim.

Completed
Registry status
Phase 2
Development phase
243
Enrollment target
20
Study locations

NCT04750577 is a Phase 2 study of Diabetic Nephropathies that has completed, run by Boehringer Ingelheim. The registered enrollment target is 243 participants, above the 107-participant average among 12 other Diabetic Nephropathies trials with a reported enrollment target (127% higher). The trial reports 20 study locations across 12 states.

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The verdict

NCT04750577, a Phase 2 study of Diabetic Nephropathies, has completed, sponsored by Boehringer Ingelheim.

COMPLETED
Registry status
Phase 2
Development phase
243 participants
Enrollment target
20
Study locations

Study Summary

This study is open to adults with diabetic kidney disease. The purpose of the study is to find out whether a medicine called BI 685509 improves kidney function. Three different doses of BI 685509 are tested in this study. Participants get either one of the three doses of BI 685509 or placebo. It is decided by chance who gets which BI 685509 dose and who gets placebo. Participants take BI 685509 or placebo as tablets 3 times a day. Placebo tablets look like BI 685509 tablets but do not contain any medicine. Participants continue taking their usual medicine for diabetes and kidney disease throughout the study. Participants are in the study for about 7 months. During this time, they visit the study site about 11 times. Where possible, about 6 of the 11 visits can be done at the participant's home instead of the study site. The trial staff may also contact the participants by phone or video call. Kidney function is assessed based on the analysis of urine samples, which participants collect at home. At the end of the trial the results are compared between the different doses of BI 685509 and placebo. During the study, the doctors also regularly check the general health of the participants.

Conditions Studied

Diabetic Nephropathies

Interventions

  • DRUG Placebo matching BI 685509
  • DRUG BI 685509

Study Locations (20)

Texas

  • DaVita Clinical Research - Houston
  • Texas Institute for Kidney and Endocrine Disorders - Lufkin
  • Clinical Advancement Center, PLLC - San Antonio
  • DaVita Clinical Research - San Antonio
  • Kidney Specialists of North Houston, PLLC - Shenandoah

Other

  • CEDIC - Centro de Investigacion Clinica - CABA
  • Instituto Médico Especializado - Capital Federal
  • Instituto Privado de Investigaciones Clínica Córdoba S.A. - Córdoba

Florida

  • Indago Research and Health Center - Hialeah
  • Panax Clinical Research - Miami Lakes

Georgia

  • Davita Clinical Research - Columbus
  • Meridian Clinical Research, LLC - Savannah

California

  • Kidney & Hypertension Center - Victorville

Connecticut

  • Chase Medical Research, LLC - Waterbury

Illinois

  • Research by Design, LLC - Chicago

Nevada

  • DaVita Clinical Research - Las Vegas

Trial Details

FieldValue
Enrollment Target 243 participants
Start Date 2021-04-27
Est. Completion 2022-12-27
Phase Phase 2

Sponsor

Boehringer Ingelheim

515 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04750577

The ClinicalTrials.gov registry entry for NCT04750577 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 243 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 107-participant average among 12 other Diabetic Nephropathies trials with a reported enrollment target (127% higher). The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Diabetic Nephropathies appearing as the primary indexed condition, and to 2 interventions - of which Placebo matching BI 685509 is the first listed.

NCT04750577 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Texas, Other, Florida.

Frequently Asked Questions

What is clinical trial NCT04750577 about?

NCT04750577 is a clinical study titled "A Study to Test the Effect of Different Doses of BI 685509 on Kidney Function in People With Diabetic Kidney Disease". This study is open to adults with diabetic kidney disease. The purpose of the study is to find out whether a medicine called BI 685509 improves kidney function. Three different doses of BI 685509 are tested in this study. Participants get either one of the three doses of BI 685509 or placebo. It is...

What is the current status of trial NCT04750577?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 243 participants. The study started on 2021-04-27. Estimated completion is 2022-12-27.

What conditions does trial NCT04750577 study?

This clinical trial studies the following conditions: Diabetic Nephropathies.

What interventions are being tested in trial NCT04750577?

The interventions under investigation include: Placebo matching BI 685509 (DRUG), BI 685509 (DRUG).

Who is sponsoring clinical trial NCT04750577?

This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04750577 being conducted?

This trial has 20 study locations across California, Connecticut, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.