Trial · NCT02545049
Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease
NCT02545049, Phase 3, Completed, Bayer; results first posted 2022-04-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease. Trials, record NCT02545049. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02545049
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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 the Clinical Diagnosis of Diabetic Kidney Disease
- NCT number
- NCT02545049
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 7,352 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Diabetic Kidney Disease
- Interventions
- Finerenone (BAY94-8862), Placebo
- First posted
- 2015-09-09
- Last updated
- 2022-04-15
- Other registries' IDs
- eudract:2015-000950-39
- Results first posted
- 2022-04-15
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 Cardiovascular Death, Non-fatal Myocardial Infarction, Non Fatal Stroke, or Hospitalization for Heart Failure. | From randomization up until the first occurrence of the CV composite endpoint, or censoring at the end of the study, with an average study duration of 41 months. | Number of participants with the first occurrence of the primary cardiovascular (CV) composite outcome, CV death, non-fatal myocardial infarction (MI), non-fatal stroke, or hospitalization for heart failure were reported as descriptive result. |
| Secondary | 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 renal composite endpoint, or censoring at the end of the study, with an average study duration of 41 months. | Number of participants with 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 were reported as descriptive result. |
| 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 study duration of 41 months | Number of participants with first occurrence of a hospitalization event were reported as descriptive result. |
| Secondary | All-cause Mortality | From randomization up until death due to any cause, or censoring at the end of the study, with an average study duration of 41 months | Number of participants with death due to any cause were reported as descriptive result. 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 | Change in Urinary Albumin-to-creatine Ratio (UCAR) 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 renal composite endpoint, or censoring at the end of the study, with an average study duration of 41 months | Number of participants with first occurrence of the 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 reported as descriptive result. |
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 Cardiovascular Death, Non-fatal Myocardial Infarction, Non Fatal Stroke, or Hospitalization for Heart Failure. | From randomization up until the first occurrence of the CV composite endpoint, or censoring at the end of the study, with an average study duration of 41 months. | Full analysis set (FAS) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 renal composite endpoint, or censoring at the end of the study, with an average study duration of 41 months. | 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 study duration of 41 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, with an average study duration of 41 months | Full analysis set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in Urinary Albumin-to-creatine Ratio (UCAR) 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 renal composite endpoint, or censoring at the end of the study, with an average study duration of 41 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 Cardiovascular Death, Non-fatal Myocardial Infarction, Non Fatal Stroke, or Hospitalization for Heart Failure. | Finerenone | 458 | Participants | ||
| The First Occurrence of the Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non Fatal Stroke, or Hospitalization for Heart Failure. | Placebo | 519 | 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. | Finerenone | 350 | 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 | 395 | Participants | ||
| All-cause Hospitalization | Finerenone | 1573 | Participants | ||
| All-cause Hospitalization | Placebo | 1605 | Participants | ||
| All-cause Mortality | Finerenone | 333 | Participants | ||
| All-cause Mortality | Placebo | 370 | Participants | ||
| Change in Urinary Albumin-to-creatine Ratio (UCAR) From Baseline to Month 4 | Finerenone | 0.624 | 95% Confidence Interval 0.606 to 0.642 | Ratio | |
| Change in Urinary Albumin-to-creatine Ratio (UCAR) From Baseline to Month 4 | Placebo | 0.922 | 95% Confidence Interval 0.896 to 0.949 | 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 | 3,723 | |
| Overall Study | STARTED | Placebo | 3,714 | |
| Overall Study | Treated | Finerenone | 3,683 | |
| Overall Study | Treated | Placebo | 3,658 | |
| Overall Study | Included in FAS | Finerenone | 3,686 | |
| Overall Study | Included in FAS | Placebo | 3,666 | |
| Overall Study | COMPLETED | Finerenone | 3,681 | |
| Overall Study | COMPLETED | Placebo | 3,653 | |
| Overall Study | NOT COMPLETED | Finerenone | 42 | |
| Overall Study | NOT COMPLETED | Placebo | 61 |
Source ClinicalTrials.gov
Adverse events2,270
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 | 210 | 3,683 | 227 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 199 | 3,658 | 215 |
| other | Constipation | Gastrointestinal disorders | Finerenone | 185 | 3,683 | 213 |
| other | Constipation | Gastrointestinal disorders | Placebo | 171 | 3,658 | 192 |
| other | Diarrhoea | Gastrointestinal disorders | Finerenone | 235 | 3,683 | 283 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 220 | 3,658 | 271 |
| other | Oedema peripheral | General disorders | Finerenone | 197 | 3,683 | 227 |
| other | Oedema peripheral | General disorders | Placebo | 278 | 3,658 | 343 |
| other | Bronchitis | Infections and infestations | Finerenone | 191 | 3,683 | 238 |
| other | Bronchitis | Infections and infestations | Placebo | 176 | 3,658 | 214 |
1 to 10 of 2,270Source ClinicalTrials.gov
See all 2,270 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Finerenone | 339 | 3,686 |
| Total, all-cause mortality | Placebo | 383 | 3,666 |
| Total, other adverse events | Finerenone | 1,797 | 3,683 |
| Total, other adverse events | Placebo | 1,717 | 3,658 |
| Total, serious adverse events | Finerenone | 1,158 | 3,683 |
| Total, serious adverse events | Placebo | 1,215 | 3,658 |
Source ClinicalTrials.gov
Papers24
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: 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: All-cause Hospitalization | Trial comparisons |
| Finerenone vs Placebo: deaths from any cause | Trial comparisons |
| 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 in eGFR of ≥57% 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: 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.
Data dates
The day each source was copied for this release.
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.
GET https://conductscience.org/api/trials/v1/NCT02545049
GET https://conductscience.org/api/trials/v1/NCT02545049/events?page=2