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

Conditions

• Kidney Disease, Chronic

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• BI 690517 — DRUG
  Film-coated tablets
• Placebo to BI 690517 — DRUG
  Film-coated tablets
• Empagliflozin — DRUG
  Empagliflozin
• Placebo to empagliflozin — DRUG
  Placebo to empagliflozin

Study Details

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.

Key Dates

Start date

Jan 11, 2022

Status verified

Oct 2024

Primary completion

Jun 19, 2023

Completion

Jul 10, 2023

Study Design

Enrollment

714 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Run-in period: 10 mg empagliflozin
• Placebo Comparator: Run-in period: Placebo to empagliflozin 10 mg
• Experimental: Treatment period: 10 mg empagliflozin + 3 mg BI 690517
• Experimental: Treatment period: 10 mg empagliflozin + 10 mg BI 690517
• Experimental: Treatment period: 10 mg empagliflozin + 20 mg BI 690517
• Placebo Comparator: Treatment period: 10 mg empagliflozin + Placebo to BI 690517
• Experimental: Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517
• Experimental: Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517
• Experimental: Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517
• Placebo Comparator: Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517

Primary Outcome Measure

Change From Treatment Period Baseline in Log Transformed Urine Albumin Creatinine Ratio (UACR) Measured in First Morning Void (FMV) Urine After 14 Weeks - All Patients [ Time Frame: The MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week 6,7 or 8 of the Run-in period) and Week 6, Week 10 and Week 12-14 of Treatment period. ]

Locations (41)

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