Trial · NCT02540993
Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease
NCT02540993, Phase 3, Completed, Bayer; results first posted 2021-07-19
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease. Trials, record NCT02540993. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02540993
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease
- NCT number
- NCT02540993
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 5,734 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Chronic Kidney Disease
- Interventions
- Finerenone (BAY94-8862), Placebo
- First posted
- 2015-09-04
- Last updated
- 2023-07-24
- Other registries' IDs
- eudract:2015-000990-11
- Results first posted
- 2021-07-19
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The First Occurrence of the Composite Endpoint of Onset of Kidney Failure, a Sustained Decrease of eGFR ≥40% From Baseline Over at Least 4 Weeks, or Renal Death | From randomization up until the first occurrence of the primary renal composite endpoint, or censoring at the end of the study, with an average follow-up time of 32 months | Count of participants and time from randomization to the first occurrence of the primary renal composite outcome, onset of kidney failure, a sustained decrease of eGFR ≥40% from baseline over at least 4 weeks, or renal death were evaluated. Number of participants with the outcome event is reported as descriptive result and hazard ratio is reported as statistical analysis. |
| Secondary | The First Occurrence of the Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke, or Hospitalization for Heart Failure | From randomization up until the first occurrence of the key secondary CV composite endpoint, or censoring at the end of the study, with an average of 32 months | Count of participants and time from randomization to the first occurrence of the key secondary cardiovascular (CV) composite outcome, CV death, non-fatal myocardial infarction (MI), non-fatal stroke, or hospitalization for heart failure were evaluated. Number of participants with the outcome event is reported as descriptive result and hazard ratio is reported as statistical analysis. |
| Secondary | All-cause Mortality | From randomization up until death due to any cause, or censoring at the end of the study visit, with an average of 32 months | Count of participants and time from randomization until death due to any cause were evaluated. Number of participants with outcome death is reported as descriptive result and hazard ratio is reported as statistical analysis. Number of participants with outcome death reported here includes deaths occurred after randomization until the end of the study visit. Deaths after end of study visit are not included in this table. |
| Secondary | All-cause Hospitalization | From randomization up until the first occurrence of the hospitalization due to any cause, or censoring at the end of study, with an average of 32 months | Count of participants and time from randomization to the first occurrence of a hospitalization event were evaluated. Number of participants with the event is reported as descriptive result and hazard ratio is reported as statistical analysis. |
| Secondary | Change in Urinary Albumin-to-creatinine Ratio (UACR) From Baseline to Month 4 | From baseline up until Month 4 | First morning void urine samples were collected to evaluate the urinary albumin-to-creatinine ratio (UACR). Month 4 was the visit closest to day 120 within a time window of 120 ± 30 days after randomization. If no measurements were available in this time window, the participant was excluded from this analysis. Ratio of UACR at Month 4 to UACR at baseline is reported as the change. |
| Secondary | The First Occurrence of the Composite Endpoint of Onset of Kidney Failure, a Sustained Decrease in eGFR of ≥57% From Baseline Over at Least 4 Weeks, or Renal Death | From randomization up until the first occurrence of the composite primary endpoint, or censoring at the end of the study, with an average of 32 months | Count of participants and time from randomization to the first occurrence of the secondary renal composite outcome, onset of kidney failure, a sustained decrease in eGFR of ≥57% from baseline over at least 4 weeks, or renal death were evaluated. Number of participants with the outcome event is reported as descriptive result and hazard ratio is reported as statistical analysis. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The First Occurrence of the Composite Endpoint of Onset of Kidney Failure, a Sustained Decrease of eGFR ≥40% From Baseline Over at Least 4 Weeks, or Renal Death | From randomization up until the first occurrence of the primary renal composite endpoint, or censoring at the end of the study, with an average follow-up time of 32 months | Full analysis set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | The First Occurrence of the Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke, or Hospitalization for Heart Failure | From randomization up until the first occurrence of the key secondary CV composite endpoint, or censoring at the end of the study, with an average of 32 months | Full analysis set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | All-cause Mortality | From randomization up until death due to any cause, or censoring at the end of the study visit, with an average of 32 months | Full analysis set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | All-cause Hospitalization | From randomization up until the first occurrence of the hospitalization due to any cause, or censoring at the end of study, with an average of 32 months | Full analysis set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in Urinary Albumin-to-creatinine Ratio (UACR) From Baseline to Month 4 | From baseline up until Month 4 | Subjects in full analysis set with measurements available within the time window of Month 4 | Ratio | LEAST_SQUARES_MEAN |
| SECONDARY | The First Occurrence of the Composite Endpoint of Onset of Kidney Failure, a Sustained Decrease in eGFR of ≥57% From Baseline Over at Least 4 Weeks, or Renal Death | From randomization up until the first occurrence of the composite primary endpoint, or censoring at the end of the study, with an average of 32 months | Full analysis set | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The First Occurrence of the Composite Endpoint of Onset of Kidney Failure, a Sustained Decrease of eGFR ≥40% From Baseline Over at Least 4 Weeks, or Renal Death | Finerenone | 504 | Participants | ||
| The First Occurrence of the Composite Endpoint of Onset of Kidney Failure, a Sustained Decrease of eGFR ≥40% From Baseline Over at Least 4 Weeks, or Renal Death | Placebo | 600 | Participants | ||
| The First Occurrence of the Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke, or Hospitalization for Heart Failure | Finerenone | 367 | Participants | ||
| The First Occurrence of the Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke, or Hospitalization for Heart Failure | Placebo | 420 | Participants | ||
| All-cause Mortality | Finerenone | 219 | Participants | ||
| All-cause Mortality | Placebo | 244 | Participants | ||
| All-cause Hospitalization | Finerenone | 1263 | Participants | ||
| All-cause Hospitalization | Placebo | 1321 | Participants | ||
| Change in Urinary Albumin-to-creatinine Ratio (UACR) From Baseline to Month 4 | Finerenone | 0.655 | 95% Confidence Interval 0.637 to 0.673 | Ratio | |
| Change in Urinary Albumin-to-creatinine Ratio (UACR) From Baseline to Month 4 | Placebo | 0.952 | 95% Confidence Interval 0.927 to 0.979 | Ratio |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Finerenone | 2,866 | |
| Overall Study | STARTED | Placebo | 2,868 | |
| Overall Study | Included in FAS | Finerenone | 2,833 | |
| Overall Study | Included in FAS | Placebo | 2,841 | |
| Overall Study | Treated | Finerenone | 2,827 | |
| Overall Study | Treated | Placebo | 2,831 | |
| Overall Study | COMPLETED | Finerenone | 2,824 | |
| Overall Study | COMPLETED | Placebo | 2,832 | |
| Overall Study | NOT COMPLETED | Finerenone | 42 | |
| Overall Study | NOT COMPLETED | Placebo | 36 |
Source ClinicalTrials.gov
Adverse events1,934
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 | Anaemia | Blood and lymphatic system disorders | Finerenone | 201 | 2,827 | 218 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 177 | 2,831 | 196 |
| other | Constipation | Gastrointestinal disorders | Finerenone | 128 | 2,827 | 146 |
| other | Constipation | Gastrointestinal disorders | Placebo | 162 | 2,831 | 179 |
| other | Diarrhoea | Gastrointestinal disorders | Finerenone | 183 | 2,827 | 216 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 188 | 2,831 | 224 |
| other | Oedema peripheral | General disorders | Finerenone | 183 | 2,827 | 216 |
| other | Oedema peripheral | General disorders | Placebo | 303 | 2,831 | 359 |
| other | Bronchitis | Infections and infestations | Finerenone | 127 | 2,827 | 140 |
| other | Bronchitis | Infections and infestations | Placebo | 142 | 2,831 | 188 |
1 to 10 of 1,934Source ClinicalTrials.gov
See all 1,934 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Finerenone | 222 | 2,833 |
| Total, all-cause mortality | Placebo | 250 | 2,841 |
| Total, other adverse events | Finerenone | 1,602 | 2,827 |
| Total, other adverse events | Placebo | 1,584 | 2,831 |
| Total, serious adverse events | Finerenone | 902 | 2,827 |
| Total, serious adverse events | Placebo | 971 | 2,831 |
Source ClinicalTrials.gov
Papers33
The papers the trial lists on ClinicalTrials.gov.
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 comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Finerenone vs Placebo: All-cause Mortality | Trial comparisons |
| Finerenone vs Placebo: The First Occurrence of the Composite Endpoint of Onset of Kidney Failure, a Sustained Decrease of eGFR ≥40% From Baseline Over at Least 4 Weeks, or Renal Death | Trial comparisons |
| Finerenone vs Placebo: The First Occurrence of the Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke, or Hospitalization for Heart Failure | Trial comparisons |
| Finerenone vs Placebo: All-cause Hospitalization | Trial comparisons |
| Finerenone vs Placebo: The First Occurrence of the Composite Endpoint of Onset of Kidney Failure, a Sustained Decrease in eGFR of ≥57% From Baseline Over at Least 4 Weeks, or Renal Death | Trial comparisons |
| Finerenone vs Placebo: deaths from any cause | Trial comparisons |
| Finerenone vs Placebo: serious adverse events | Trial comparisons |
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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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.
GET https://conductscience.org/api/trials/v1/NCT02540993
GET https://conductscience.org/api/trials/v1/NCT02540993/events?page=2