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NCT02540993 · ClinicalTrials.gov registry record · Phase 3

Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease

A Phase 3 study, sponsored by Bayer.

Completed
Registry status
Phase 3
Development phase
5,734
Enrollment target

NCT02540993: Completed Phase 3 study, sponsored by Bayer.

NCT02540993 is a Phase 3 study that has completed, run by Bayer. The registered enrollment target is 5,734 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (643% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02540993, a Phase 3 study, has completed, sponsored by Bayer.

COMPLETED
Registry status
Phase 3
Development phase
5,734 participants
Enrollment target

Study Summary

The primary objective of this study was to demonstrate whether, in addition to standard of care, finerenone is superior to placebo in delaying the progression of kidney disease, as measured by the composite endpoint of time to first occurrence of kidney failure, a sustained decrease of estimated glomerular filtration rate (eGFR) ≥40% from baseline over at least 4 weeks, or renal death.

Primary Outcome

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.

Interventions

  • DRUG Placebo
  • DRUG Finerenone (BAY94-8862)

Trial Details

FieldValue
Enrollment Target 5,734 participants
Start Date 2015-09-17
Est. Completion 2020-04-14
Phase Phase 3
Bayer

591 total trials

What the finished NCT02540993 record still lists

NCT02540993 is an interventional study that assigns participants to a tested intervention. Its 5,734 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (643% higher).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT02540993 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02540993 about?

NCT02540993 is a clinical study titled "Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease". The primary objective of this study was to demonstrate whether, in addition to standard of care, finerenone is superior to placebo in delaying the progression of kidney disease, as measured by the composite endpoint of time to first occurrence of kidney failure, a sustained decrease of estimated glo...

What is the current status of trial NCT02540993?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 5,734 participants. The study started on 2015-09-17. Estimated completion is 2020-04-14.

What interventions are being tested in trial NCT02540993?

The interventions under investigation include: Placebo (DRUG), Finerenone (BAY94-8862) (DRUG).

Who is sponsoring clinical trial NCT02540993?

This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02540993's enrollment target sits among peer trials

5,734 42nd of 2000 higher than 1,959 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02540993, the US trial registry maintained by the National Library of Medicine. NCT02540993 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.