Diabetes Mellitus Type 2 and Diabetic Kidney Disease

Protocol Title
A randomized, double-blind, placebo-controlled, parallel-group, multicenter, eventdriven phase III study to investigate the efficacy and safety 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 (16244 Fidelio-DKD)

Principal Investigator
Alan Perlman, MD
Office Number: (212) 746-1580
Email: alp9021@nyp.org

Study Status
Open for Enrollment

Brief Summary of the Protocol
The purpose of this study is to find out whether finerenone, an investigational drug (not approved by the Food and Drug Administration), is effective and safe in treating subjects with diabetes mellitus type 2 and Diabetic Kidney Disease (DKD) along with their regularly prescribed medication.

Finerenone, the study drug, works by blocking the effects of aldosterone, a hormone that is related to the progression of kidney disease as well as heart disease, in individuals with diabetes mellitus type 2.

Diabetes mellitus type 2 is a chronic disease in which the body cannot properly use insulin, a hormone that regulates blood sugar levels in the body; or, it does not produce enough insulin, which usually leads to increased blood sugar levels and other complications. DKD is a complication affecting the kidneys of subjects with diabetes mellitus type 2. DKD can progress to kidney failure, called End Stage Renal Disease, which is treated by dialysis or kidney transplantation.

Potential candidates are males or females, 18 years or older, with diabetes mellitus type 2 and DKD.  Participants will be randomized (like flipping a coin), into 1 of 2 possible study-treatment groups, either receiving finerenone or a placebo (inactive substance). Neither the participant nor the study staff will know if the participant is receiving study drug or placebo. Participation in this study will last approximately 3 years and 3 months, and will include a minimum of 15 visits to The Rogosin Institute.

The study involves a screening phase, the study treatment period, and a follow up period (if applicable).  Physical exams, vital signs, blood and urine tests, electrocardiograms and questionnaires will be performed at all or some of the study visits.

Potential Benefits
There is no guarantee that participants will receive direct benefit from this study. However, participation in this study may help others get a better treatment for their kidney disease in the future and allow researchers to learn more about how DKD can be delayed or managed.

Sponsor Information
Bayer HealthCare Pharmaceuticals Inc.

ClinicalTrials.gov Identifier: NCT02540993