Trial · NCT04736628

A Study to Test the Effect of Different Doses of Avenciguat (BI 685509) on Kidney Function in People With Chronic Kidney Disease

NCT04736628, Phase 2, Completed, Boehringer Ingelheim; results first posted 2024-09-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study to Test the Effect of Different Doses of Avenciguat (BI 685509) on Kidney Function in People With Chronic Kidney Disease. Trials, record NCT04736628. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04736628

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study to Test the Effect of Different Doses of Avenciguat (BI 685509) on Kidney Function in People With Chronic Kidney Disease
NCT number: NCT04736628
Status: Completed
Phases: Phase 2
Enrollment: 261 participants, actual
Lead sponsor: Boehringer Ingelheim
Conditions: Chronic Kidney Disease
Interventions: Avenciguat, Placebo
First posted: 2021-02-03
Last updated: 2024-09-04
Other registries' IDs: eudract:2020-002930-33
Results first posted: 2024-09-04

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Log Transformed Urine Albumin Creatinine Ratio (UACR) Measured in 10-hour Urine After 20 Weeks of Trial Treatment	The MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week -2, Week -1, Week 0 pre-dose) and Week 6, Week 12 and Week 20. The data represent the Least Squares Mean at Week 20.	Change from baseline in log transformed Urine Albumin Creatinine Ratio (UACR) measured in 10-hour urine after 20 weeks of trial treatment is reported. Least Squares Mean (Standard error) were estimated by restricted maximum likelihood (REML)-based mixed-effect model for repeated measures (MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12, and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient. Log transformed UACR at Week 20 was log of (average of all available scheduled measurements between week 18 and week 20). The data in the Outcome Measure Data Table represent the Least Squares Mean (Standard error) at Week 20.
Secondary	Change From Baseline in Log Transformed UACR Measured in First Morning Void Urine After 20 Weeks of Trial Treatment	The MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week -2 and Week -1) and Week 6, Week 12 and Week 20. The data represent the Least Squares Mean at Week 20.	Change from baseline in log transformed UACR measured in First Morning Void urine after 20 weeks of trial treatment is reported. Least Squares Mean (Standard error) were estimated by restricted maximum likelihood (REML)-based mixed-effect model for repeated measures (MMRM) including the fixed, categorical effects of treatment at each visit (baseline, Week 6, Week 12 and Week 20), and the continuous effect of baseline at each visit (Week 6, Week 12, and Week 20) as well as random effects of patient. The first morning void (FMV) was the first urination after the patient woke up at their usual time to start their day. Log transformed UACR at Week 20 was log of (average of all available scheduled measurements between week 18 and week 20). The data in the Outcome Measure Data Table represent the Least Squares Mean (Standard error) at Week 20.
Secondary	Number of Patients Achieving UACR Decreases in 10-hour Urine of at Least 20% From Baseline After 20 Weeks of Trial Treatment	At baseline (Day -14 and Day -7) and at Week 20 (Day 141) after start of trial treatment.	Number of patients achieving urine albumin creatinine ratio (UACR) decreases in 10-hour urine of at least 20% from baseline after 20 weeks of trial treatment. During the 10-hour period every time the patient urinates, and the patient collected their urine into a provided container. An aliquot of this urine was taken and used as the 10-hour UACR sample.
Secondary	Number of Patients Achieving UACR Decreases in First Morning Void Urine of at Least 20% From Baseline After 20 Weeks of Trial Treatment	At baseline (Day -14 and Day -7) and at Week 20 (Day 141) after start of trial treatment.	Number of patients achieving urine albumin creatinine ratio (UACR) decreases in First Morning Void urine of at least 20% from baseline after 20 weeks of trial treatment is reported. The first morning void (FMV) was the first urination after the patient woke up at their usual time to start their day.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Log Transformed Urine Albumin Creatinine Ratio (UACR) Measured in 10-hour Urine After 20 Weeks of Trial Treatment	The MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week -2, Week -1, Week 0 pre-dose) and Week 6, Week 12 and Week 20. The data represent the Least Squares Mean at Week 20.	Full Analysis Set (FAS): included all patients who had at least one baseline measurement of UACR in Week -2, -1, or 0 and at least 1 post-baseline measurement after Week 6.	log (mg/g)	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Log Transformed UACR Measured in First Morning Void Urine After 20 Weeks of Trial Treatment	The MMRM model is a longitudinal analysis and it incorporated UACR measurements from baseline (Week -2 and Week -1) and Week 6, Week 12 and Week 20. The data represent the Least Squares Mean at Week 20.	Full Analysis Set (FAS): included all patients who had at least one baseline measurement of UACR in Week -2, -1, or 0 and at least 1 post-baseline measurement after Week 6.	log (mg/g)	LEAST_SQUARES_MEAN
SECONDARY	Number of Patients Achieving UACR Decreases in 10-hour Urine of at Least 20% From Baseline After 20 Weeks of Trial Treatment	At baseline (Day -14 and Day -7) and at Week 20 (Day 141) after start of trial treatment.	Full Analysis Set (FAS): included all patients who had at least one baseline measurement of UACR in Week -2, -1, or 0 and at least 1 post-baseline measurement after Week 6.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Patients Achieving UACR Decreases in First Morning Void Urine of at Least 20% From Baseline After 20 Weeks of Trial Treatment	At baseline (Day -14 and Day -7) and at Week 20 (Day 141) after start of trial treatment.	Full Analysis Set (FAS): included all patients who had at least one baseline measurement of UACR in Week -2, -1, or 0 and at least 1 post-baseline measurement after Week 6.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group16

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline in Log Transformed Urine Albumin Creatinine Ratio (UACR) Measured in 10-hour Urine After 20 Weeks of Trial Treatment	Avenciguat 1 mg TID	-0.210	Standard Error 0.067	log (mg/g)
Change From Baseline in Log Transformed Urine Albumin Creatinine Ratio (UACR) Measured in 10-hour Urine After 20 Weeks of Trial Treatment	Avenciguat 2 mg TID	-0.190	Standard Error 0.068	log (mg/g)
Change From Baseline in Log Transformed Urine Albumin Creatinine Ratio (UACR) Measured in 10-hour Urine After 20 Weeks of Trial Treatment	Avenciguat 3 mg TID	-0.217	Standard Error 0.068	log (mg/g)
Change From Baseline in Log Transformed Urine Albumin Creatinine Ratio (UACR) Measured in 10-hour Urine After 20 Weeks of Trial Treatment	Placebo	0.018	Standard Error 0.068	log (mg/g)
Change From Baseline in Log Transformed UACR Measured in First Morning Void Urine After 20 Weeks of Trial Treatment	Avenciguat 1 mg TID	-0.190	Standard Error 0.071	log (mg/g)
Change From Baseline in Log Transformed UACR Measured in First Morning Void Urine After 20 Weeks of Trial Treatment	Avenciguat 2 mg TID	-0.180	Standard Error 0.073	log (mg/g)
Change From Baseline in Log Transformed UACR Measured in First Morning Void Urine After 20 Weeks of Trial Treatment	Avenciguat 3 mg TID	-0.161	Standard Error 0.071	log (mg/g)
Change From Baseline in Log Transformed UACR Measured in First Morning Void Urine After 20 Weeks of Trial Treatment	Placebo	0.027	Standard Error 0.072	log (mg/g)
Number of Patients Achieving UACR Decreases in 10-hour Urine of at Least 20% From Baseline After 20 Weeks of Trial Treatment	Avenciguat 1 mg TID	25		Participants
Number of Patients Achieving UACR Decreases in 10-hour Urine of at Least 20% From Baseline After 20 Weeks of Trial Treatment	Avenciguat 2 mg TID	27		Participants

1 to 10 of 16Source ClinicalTrials.gov

See all 16 results by group

Participant flow16

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Avenciguat 1 mg TID	64
Overall Study	STARTED	Avenciguat 2 mg TID	65
Overall Study	STARTED	Avenciguat 3 mg TID	66
Overall Study	STARTED	Placebo	66
Overall Study	Treated	Avenciguat 1 mg TID	64
Overall Study	Treated	Avenciguat 2 mg TID	65
Overall Study	Treated	Avenciguat 3 mg TID	66
Overall Study	Treated	Placebo	64
Overall Study	COMPLETED	Avenciguat 1 mg TID	58
Overall Study	COMPLETED	Avenciguat 2 mg TID	60

1 to 10 of 16Source ClinicalTrials.gov

See all 16 participant flow

Adverse events112

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Diarrhoea	Gastrointestinal disorders	Avenciguat 1 mg TID	2	64
other	Diarrhoea	Gastrointestinal disorders	Avenciguat 2 mg TID	3	65
other	Diarrhoea	Gastrointestinal disorders	Avenciguat 3 mg TID	6	66
other	Diarrhoea	Gastrointestinal disorders	Placebo	4	64
other	Nausea	Gastrointestinal disorders	Avenciguat 1 mg TID	2	64
other	Nausea	Gastrointestinal disorders	Avenciguat 2 mg TID	0	65
other	Nausea	Gastrointestinal disorders	Avenciguat 3 mg TID	4	66
other	Nausea	Gastrointestinal disorders	Placebo	1	64
other	Fatigue	General disorders	Avenciguat 1 mg TID	0	64
other	Fatigue	General disorders	Avenciguat 2 mg TID	2	65

1 to 10 of 112Source ClinicalTrials.gov

See all 112 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Avenciguat 1 mg TID	0	64
Total, all-cause mortality	Avenciguat 2 mg TID	0	65
Total, all-cause mortality	Avenciguat 3 mg TID	0	66
Total, all-cause mortality	Placebo	0	64
Total, other adverse events	Avenciguat 1 mg TID	17	64
Total, other adverse events	Avenciguat 2 mg TID	19	65
Total, other adverse events	Avenciguat 3 mg TID	26	66
Total, other adverse events	Placebo	21	64
Total, serious adverse events	Avenciguat 1 mg TID	3	64
Total, serious adverse events	Avenciguat 2 mg TID	3	65

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
38795055	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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