Last updated on November 2017

A randomized, double placebo-controlled, parallel group, multi-center, event driven phase II study to investigate the efficacy and safety of Finerenone, in addition to standard care, on the progression of kidney disease in subjects with type II diabetes and the clinical diagnosis of diabetic kidney.


Brief description of study

A randomized, double placebo-controlled, parallel group, multi-center, event driven phase II study to investigate the efficacy and safety of Finerenone, in addition to standard care, on the progression of kidney disease in subjects with type II diabetes and the clinical diagnosis of diabetic kidney.

Detailed Study Description

The primary objective of this study is to:

  • Demonstrate whether, in addition to standard of care (SoC), 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 eGFR ≥ 40% from baseline over at least 4 weeks, or renal death

The secondary objectives of this study are to determine whether, in addition to SoC, finerenone compared to placebo:

  • Delays the time to first occurrence of the following composite endpoint: CV death or non-fatal CV events (i.e. non-fatal myocardial infarction, non-fatal stroke, hospitalization for heart failure [HF])
  • Delays the time to all-cause mortality
  • Delays the time to all-cause hospitalization
  • Change in UACR from baseline to Month 4
  • Delays the time to first occurrence of the following composite endpoint: onset of kidney failure, a sustained decrease of eGFR ≥ 57% from baseline over at least 4 weeks, or renal death

Clinical Study Identifier: TX7512

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Tracy Spinola

Chase Medical Research, LLC
Waterbury, CT USA
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