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A Study to Test Whether Different Doses of BI 690517 Alone or in Combination With Empagliflozin Improve Kidney Function in People With Chronic Kidney Disease

NCT05182840 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 714

Last updated 2024-10-22

Study results available
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Summary

This study is open to adults with chronic kidney disease. People with and without type 2 diabetes can take part in this study.

The purpose of this study is to find out whether a medicine called BI 690517 improves kidney function in people with chronic kidney disease when taken alone or in combination with a medicine called empagliflozin.

In the first part of the study, participants take empagliflozin or placebo as tablets every day for 2 months. Placebo tablets look like empagliflozin tablets but do not contain any medicine.

In the second part, participants are divided into several groups. Depending on the group, the participants then additionally take different doses of BI 690517 or placebo as tablets for 3.5 months. In this case, placebo tablets look like BI 690517 tablets but do not contain any medicine.

Participants are in the study for about 6 months. During this time, they visit the study site about 12 times. Where possible, about 4 of the 12 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.

Participants collect urine samples at home. These samples are then analysed to assess kidney function. At the end of the trial the results are compared between the different groups. The doctors also regularly check participants' health and take note of any unwanted effects.

Conditions

  • Kidney Disease, Chronic

Interventions

DRUG

BI 690517

Film-coated tablets

DRUG

Placebo to BI 690517

Film-coated tablets

DRUG

Empagliflozin

Empagliflozin

DRUG

Placebo to empagliflozin

Placebo to empagliflozin

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-11
Primary Completion
2023-06-19
Completion
2023-07-10
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • China
  • Czechia
  • Finland
  • Germany
  • Greece
  • Hong Kong
  • Hungary
  • India
  • Italy
  • Japan
  • Malaysia
  • Mexico
  • Norway
  • Philippines
  • Poland
  • Portugal
  • South Africa
  • South Korea
  • Spain
  • Sweden
  • Switzerland
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05182840 on ClinicalTrials.gov