Trial · NCT01874431

Safety and Efficacy of Different Oral Doses of BAY94-8862 in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Nephropathy

NCT01874431, Phase 2, Completed, Bayer; results first posted 2021-05-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Efficacy of Different Oral Doses of BAY94-8862 in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Nephropathy. Trials, record NCT01874431. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01874431

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Trial

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

Title: Safety and Efficacy of Different Oral Doses of BAY94-8862 in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Nephropathy
NCT number: NCT01874431
Status: Completed
Phases: Phase 2
Enrollment: 823 participants, actual
Lead sponsor: Bayer
Conditions: Diabetic Nephropathies
Interventions: Finerenone (BAY94-8862), Placebo
First posted: 2013-06-11
Last updated: 2021-07-01
Other registries' IDs: eudract:2012-004179-38
Results first posted: 2021-05-04

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	Ratio of UACR at Day 90 to UACR at Baseline	Baseline and Day 90±2	Albumin-to-creatinine ratio (UACR) is defined as gram of albumin per kilogram of creatinine. UACR was calculating the average of 3 first morning void samples taken on 3 consecutive days.
Secondary	Change From Baseline to Day 90 in Serum Potassium	Baseline and Day 90±2
Secondary	Change From Baseline to Day 90 in eGFR	Baseline and Day 90±2	An estimated glomerular filtration rate (eGFR) indicates the renal function. An eGFR was calculated based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.
Secondary	Change From Baseline to Day 90 in KDQOL-36 Domain Score (Effects of Kidney Disease)	Baseline and Day 90±2	The Kidney Disease QOL \[KDQOL\]-36 questionnaire is a specific measure of Health-Related Quality of Life (HRQoL) for chronic kidney disease (CKD) that includes effects and burden of kidney disease as well as physical and mental health scores. Index score ranges from 0 (severe problems in all items) to 100 (no problem in all items). "Effects of Kidney disease" subscore was analyzed.
Secondary	Change From Baseline to Day 90 in EQ-5D Scores (EQ5D - Visual Analog Scale)	Baseline and Day 90±2	EuroQol Group 5-Dimension, 3-Level (EQ-5D-3L) questionnaires consist of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. EQ VAS was analyzed for this endpoint and it ranges from 0 (worst possible health state) to 100 (best possible health state).

Source ClinicalTrials.gov

Outcomes5

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Ratio of UACR at Day 90 to UACR at Baseline	Baseline and Day 90±2	Full analysis set (FAS): included all participants of the SAF who had baseline and at least one post-baseline UACR value.	Ratio	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline to Day 90 in Serum Potassium	Baseline and Day 90±2	Participants in SAF with valid data for this endpoint	millimole per liter	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline to Day 90 in eGFR	Baseline and Day 90±2	Participants in SAF with valid data for this endpoint	mL/min/1.73m^2	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline to Day 90 in KDQOL-36 Domain Score (Effects of Kidney Disease)	Baseline and Day 90±2	Participants in FAS with valid data for this endpoint	scores on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline to Day 90 in EQ-5D Scores (EQ5D - Visual Analog Scale)	Baseline and Day 90±2	Participants in FAS with valid data for this endpoint	scores on a scale	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group40

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

Outcome	Group	Value	Spread	Units
Ratio of UACR at Day 90 to UACR at Baseline	Finerenone (BAY94-8862) (1.25 mg)	0.869	90% Confidence Interval 0.772	Ratio
Ratio of UACR at Day 90 to UACR at Baseline	Finerenone (BAY94-8862) (2.5 mg)	0.89	90% Confidence Interval 0.786	Ratio
Ratio of UACR at Day 90 to UACR at Baseline	Finerenone (BAY94-8862) (5 mg)	0.824	90% Confidence Interval 0.73	Ratio
Ratio of UACR at Day 90 to UACR at Baseline	Finerenone (BAY94-8862) (7.5 mg)	0.739	90% Confidence Interval 0.653	Ratio
Ratio of UACR at Day 90 to UACR at Baseline	Finerenone (BAY94-8862) (10 mg)	0.708	90% Confidence Interval 0.627	Ratio
Ratio of UACR at Day 90 to UACR at Baseline	Finerenone (BAY94-8862) (15 mg)	0.63	90% Confidence Interval 0.563	Ratio
Ratio of UACR at Day 90 to UACR at Baseline	Finerenone (BAY94-8862) (20 mg)	0.585	90% Confidence Interval 0.523	Ratio
Ratio of UACR at Day 90 to UACR at Baseline	Placebo	0.938	90% Confidence Interval 0.829	Ratio
Change From Baseline to Day 90 in Serum Potassium	Finerenone (BAY94-8862) (1.25 mg)	0.109	95% Confidence Interval 0.030 to 0.187	millimole per liter
Change From Baseline to Day 90 in Serum Potassium	Finerenone (BAY94-8862) (2.5 mg)	0.123	95% Confidence Interval 0.043 to 0.203	millimole per liter

1 to 10 of 40Source ClinicalTrials.gov

See all 40 results by group

Participant flow32

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Finerenone (BAY94-8862) (1.25 mg)	96
Overall Study	STARTED	Finerenone (BAY94-8862) (2.5 mg)	92
Overall Study	STARTED	Finerenone (BAY94-8862) (5 mg)	100
Overall Study	STARTED	Finerenone (BAY94-8862) (7.5 mg)	98
Overall Study	STARTED	Finerenone (BAY94-8862) (10 mg)	98
Overall Study	STARTED	Finerenone (BAY94-8862) (15 mg)	125
Overall Study	STARTED	Finerenone (BAY94-8862) (20 mg)	120
Overall Study	STARTED	Placebo	94
Overall Study	Participants Received Treatment	Finerenone (BAY94-8862) (1.25 mg)	96
Overall Study	Participants Received Treatment	Finerenone (BAY94-8862) (2.5 mg)	92

1 to 10 of 32Source ClinicalTrials.gov

See all 32 participant flow

Adverse events256

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	Events
other	Diarrhoea	Gastrointestinal disorders	Finerenone (BAY94-8862) (1.25 mg)	5	96	5
other	Diarrhoea	Gastrointestinal disorders	Finerenone (BAY94-8862)(2.5 mg)	2	92	2
other	Diarrhoea	Gastrointestinal disorders	Finerenone (BAY94-8862)(5 mg)	4	100	4
other	Diarrhoea	Gastrointestinal disorders	Finerenone (BAY94-8862)(7.5 mg)	2	97	2
other	Diarrhoea	Gastrointestinal disorders	Finerenone (BAY94-8862)(10 mg)	2	98	2
other	Diarrhoea	Gastrointestinal disorders	Finerenone (BAY94-8862)(15 mg)	3	125	4
other	Diarrhoea	Gastrointestinal disorders	Finerenone (BAY94-8862)(20 mg)	5	119	5
other	Diarrhoea	Gastrointestinal disorders	Placebo	2	94	2
other	Nasopharyngitis	Infections and infestations	Finerenone (BAY94-8862) (1.25 mg)	7	96	7
other	Nasopharyngitis	Infections and infestations	Finerenone (BAY94-8862)(2.5 mg)	4	92	4

1 to 10 of 256Source ClinicalTrials.gov

See all 256 adverse events

Adverse event totals24

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Finerenone (BAY94-8862) (1.25 mg)	0	96
Total, all-cause mortality	Finerenone (BAY94-8862)(2.5 mg)	0	92
Total, all-cause mortality	Finerenone (BAY94-8862)(5 mg)	0	100
Total, all-cause mortality	Finerenone (BAY94-8862)(7.5 mg)	0	97
Total, all-cause mortality	Finerenone (BAY94-8862)(10 mg)	0	98
Total, all-cause mortality	Finerenone (BAY94-8862)(15 mg)	1	125
Total, all-cause mortality	Finerenone (BAY94-8862)(20 mg)	0	119
Total, all-cause mortality	Placebo	1	94
Total, other adverse events	Finerenone (BAY94-8862) (1.25 mg)	14	96
Total, other adverse events	Finerenone (BAY94-8862)(2.5 mg)	7	92

1 to 10 of 24Source ClinicalTrials.gov

See all 24 adverse event totals

Papers7

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
26325557	RESULT	PubMed
31583611	RESULT	PubMed
33107592	RESULT	PubMed
33358451	DERIVED	PubMed
36583355	DERIVED	PubMed
38537621	DERIVED	PubMed
40938666	DERIVED	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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