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Not Applicable

BI 690517 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 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 were used for the multiple imputation approach.

Summary

This trial tests whether a new medicine, BI 690517, alone or with empagliflozin, can improve kidney function in adults with chronic kidney disease. The study includes people with and without type 2 diabetes. The goal is to see if these medicines can help the kidneys work better.

Eligible Conditions
  • Chronic Kidney Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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 were used for the multiple imputation approach.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 were used for the multiple imputation approach. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change From Baseline to Week 14 in the Log Transformed FMV UACR - Patients With Background Therapy of Empagliflozin
Change From Baseline to Week 14 in the Log Transformed FMV UACR - Patients With Background Therapy of Placebo Matching Empagliflozin
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
+3 more
Secondary study objectives
UACR Response I, Defined as Decrease of at Least 30% Absolute Change in FMV Urine of UACR From Treatment Period Baseline to 14 Weeks - Background Therapy of Placebo Matching Empagliflozin - Last Observation on Treatment Carried Forward (LOCF)
UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Week - All Patients - Last Observation on Treatment Carried Forward (LOCF)
UACR Response I, Defined as Decrease of at Least 30% Absolute Change in First Morning Void Urine of UACR From Treatment Period Baseline to 14 Weeks - All Patients - Complete Case Analysis
+21 more

Side effects data

From 2023 Phase 2 trial • 714 Patients • NCT05182840
2%
Hyperkalaemia
1%
Upper respiratory tract infection
1%
Hypotension
1%
Glomerular filtration rate decreased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Run-in Period: Placebo to Empagliflozin 10 mg
Treatment Period: Placebo to Empagliflozin 10 mg + 10 mg BI 690517
Treatment Period: Placebo to Empagliflozin 10 mg + 20 mg BI 690517
Run-in Period: 10 mg Empagliflozin
Treatment Period: Placebo to Empagliflozin 10 mg + Placebo to BI 690517
Treatment Period: 10 mg Empagliflozin + 10 mg BI 690517
Treatment Period: 10 mg Empagliflozin + 20 mg BI 690517
Treatment Period: 10 mg Empagliflozin + 3 mg BI 690517
Treatment Period: 10 mg Empagliflozin + Placebo to BI 690517
Treatment Period: Placebo to Empagliflozin 10 mg + 3 mg BI 690517

Trial Design

10Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment period: Placebo to empagliflozin 10 mg + 3 mg BI 690517Experimental Treatment2 Interventions
Group II: Treatment period: Placebo to empagliflozin 10 mg + 20 mg BI 690517Experimental Treatment2 Interventions
Group III: Treatment period: Placebo to empagliflozin 10 mg + 10 mg BI 690517Experimental Treatment2 Interventions
Group IV: Treatment period: 10 mg empagliflozin + 3 mg BI 690517Experimental Treatment2 Interventions
Group V: Treatment period: 10 mg empagliflozin + 20 mg BI 690517Experimental Treatment2 Interventions
Group VI: Treatment period: 10 mg empagliflozin + 10 mg BI 690517Experimental Treatment2 Interventions
Group VII: Run-in period: 10 mg empagliflozinExperimental Treatment1 Intervention
Group VIII: Treatment period: 10 mg empagliflozin + Placebo to BI 690517Placebo Group2 Interventions
Group IX: Treatment period: Placebo to empagliflozin 10 mg + Placebo to BI 690517Placebo Group2 Interventions
Group X: Run-in period: Placebo to empagliflozin 10 mgPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BI 690517
2017
Completed Phase 2
~1040
Placebo to empagliflozin
2022
Completed Phase 2
~720
Empagliflozin
2017
Completed Phase 4
~181750

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Who is running the clinical trial?

Boehringer IngelheimLead Sponsor
2,550 Previous Clinical Trials
15,856,792 Total Patients Enrolled
~186 spots leftby Dec 2025
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