Summary

for people ages 18 years and up (full criteria)
at UCLA
study started
estimated completion

Description

Summary

The purpose of this study is to evaluate whether oral finerenone (study drug), in addition to standard daily therapy, is effective and safe in treating patients with type 2 diabetes mellitus and diabetic kidney disease, when compared to a placebo.

Official Title

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Event-driven Phase 3 Study to Investigate the Safety and Efficacy of Finerenone, in Addition to Standard of Care, on the Progression of Kidney Disease in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease

Keywords

Diabetic Kidney Disease Type 2 Diabetes Kidney diseases Diabetic Nephropathies Diabetes Mellitus Diabetes Mellitus, Type 2 Finerenone (BAY94-8862) BAY94-8862

Eligibility

You can join if…

Open to people ages 18 years and up

  • Men or women ≥18 years of age
  • Subjects with Type 2 diabetes mellitus as defined by the American Diabetes Association
  • Diagnosis of diabetic kidney disease (DKD) with persistent high albuminuria or persistent very high albuminuria at the Run-in and Screening visits:
  • Pretreated with either angiotensin-converting enzyme inhibitor(ACEI) or angiotensin receptor blocker (ARB) at maximal tolerated labeled dose without adjustments
  • Serum potassium <=4.8 mmol/L.

You CAN'T join if...

  • Confirmed significant non-diabetic renal disease, including clinically relevant renal artery stenosis
  • Uncontrolled arterial hypertension (ie, mean sitting systolic blood pressure (SBP) ≥170 mmHg, sitting diastolic blood pressure (DBP) ≥110 mmHg at run in visit, or mean sitting SBP ≥160 mmHg, sitting DBP ≥100 mmHg at screening)
  • Clinical diagnosis of chronic heart failure with reduced ejection fraction (HFrEF) and persistent symptoms New York Heart Association (NYHA class II - IV) at run in visit (class 1A recommendation for mineralcorticoid receptor antagonist (MRAs)
  • Dialysis for acute renal failure within 12 weeks of run in visit
  • Renal allograft in place or scheduled kidney transplant within next 12 months
  • Glycated hemoglobin HbA1c > 12%.

Locations

  • Fresno California 93721 United States
  • Los Angeles California 90025 United States
  • San Francisco California 94110 United States
  • San Diego California 92117 United States
  • Fresno California 93720 United States
  • Los Angeles California 90017 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bayer
ID
NCT02540993
Phase
Phase 3
Study Type
Interventional
Last Updated