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

Conditions

• Chronic Kidney Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Finerenone (BAY94-8862) — DRUG
  Oral tablet; starting dose at 10 mg for subjects with an eGFR between 25 to \< 60 mL/min/1.73m² at the Screening Visit; starting dose at 20 mg for subjects with an eGFR ≥ 60 mL/min/1.73m² at the Screening Visit; dose could be up-titrated from Month 1 onwards or down-titrated at any time during the study; once daily in the morning, until the trial was completed provided there were no safety grounds for discontinuing treatment
• Placebo — DRUG
  Matching placebo, oral tablet, once daily in the morning, until the trial was completed provided there were no safety grounds for discontinuing treatment

Study Details

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.

Key Dates

Start date

Sep 17, 2015

Status verified

Jul 2023

Primary completion

Apr 14, 2020

Completion

Apr 14, 2020

Study Design

Enrollment

5,734 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Finerenone (BAY94-8862)
  Participants received finerenone 10 mg or 20 mg once daily in addition to standard of care therapy
• Placebo Comparator: Placebo
  Participants received matching placebo once daily in addition to standard of care therapy

Primary Outcome Measure

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 [ Time Frame: 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 ]

Locations (176)

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