Effect of Treatment With Finerenone on Cardio-Renal Target Organ Damage in Patients With Type 2 Diabetes.

PHASE4RecruitingINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

October 23, 2024

Primary Completion Date

December 31, 2026

Study Completion Date

April 30, 2028

Conditions
Type 2 Diabetes Mellitus (T2DM)Chronic Kidney Disease Due to Type 2 Diabetes MellitusCardiovascular Diseases
Interventions
DRUG

Finerenone (BAY 94-8862)

Patients with an eGFR of 25-60 ml/min/1.73m2 will receive an initial dose of 10 mg finerenone/placebo once daily and those with an eGFR of at least 60 ml/ in/1.73m2 will receive an initial dose of 20 mg finerenone/placebo once daily. From 4 weeks the target dose is 20 mg finerenone/placebo once daily. An increase in dose from 10 to 20 mg once daily will be encouraged after 4 weeks provided the plasma potassium level is 4.8 mmol/L or less and the eGFR stable. If eGFR is reduced with \>30 % compared to the previous measurement, we will not increase the dose of finerenone/placebo. Plasma potassium and eGFR will be measured 4 weeks after any initiation, re-start or increase in dose. A decrease in dose from 20 to 10 mg is allowed at any time after initiation of finerenone or placebo. Patients in the placebo group will undergo sham adjustment of the dose. Finerenone or placebo will be withheld if potassium concentrations exceed 5.5 mmol/L and restarted if potassium levels fall to 5.0 mmol/L

DRUG

Placebo

Placebo tablets matching BAY94-8862 are administered orally.

Trial Locations (1)

8200

RECRUITING

Steno Diabetes Center Aarhus, Aarhus N

All Listed Sponsors
collaborator

Aarhus University Hospital

OTHER

lead

University of Aarhus

OTHER