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

a study on Kidney Disease Diabetes Diabetes Type 2

Summary

for people ages 18 years and up (full criteria)
at Fresno, California and other locations
study started
estimated completion:
Ramin Sam

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 Efficacy and Safety of Finerenone on the Reduction of Cardiovascular Morbidity and Mortality in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease in Addition to Standard of Care.

Keywords

Diabetic Kidney Disease Type 2 Diabetes Kidney diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetic Nephropathies 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 Type 2 Diabetes Mellitus as defined by the American Diabetes Association
  • Diagnosis of Diabetic Kidney Disease with persistent high albuminuria or persistent very high albuminuria at the Run-In and Screening Visit
  • 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 or mean sitting diastolic blood pressure(DBP) ≥110 mmHg at run in visit, or mean sitting SBP ≥160 mmHg or mean 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
  • Fresno California 93720 United States
  • Dublin California 94568 United States
  • Santa Rosa California 95405 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bayer
Links
Click here and search for drug information provided by the FDA.
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.
ID
NCT02545049
Phase
Phase 3
Lead Scientist
Ramin Sam
Study Type
Interventional
Last Updated
September 7, 2018