Chronic Kidney Disease and Diabetes type 2
Conditions
Interventions
Depending on the treatment group, the participants will either take:
- the combination of finerenone and empagliflozin,
- finerenone together with a placebo,
- empagliflozin together with a placebo
Sponsors
Bayer
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 2a: 1. Participant with a clinical diagnosis of chronic kidney disease (CKD) and the following: a. In Part A: eGFR 40-90 ml/min/1.73m^2 (with no more than 20% having an eGFR >75 ml/min/1.73m^2) using Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) formula at screening visit and at least one historical value of eGFR 75 ml/min/1.73m^2) using CKD-EPI formula at screening visit and at least one historical value of eGFR
Exclusion criteria
Exclusion criteria: 1. Participants with type 1 diabetes (T1D). 2. Participant with hepatic insufficiency classified as Child-Pugh C. 3. Participant with blood pressure at Day 1 (Visit 2) visit higher than 160 SBP or 100 DBP or systolic blood pressure lower than 90 mmHg. 4. Participant currently treated with a sodium/glucose cotransporter-2 inhibitor (SGLT2i) or SGLT-1/2i or who received a SGLT2i or SGLT-1/2i which cannot be discontinued at least 8 weeks prior to the screening visit and during study intervention treatment. 5. Participant treated with another mineralocorticoid receptor antagonist (MRA) (e.g., eplerenone, esaxerenone, spironolactone, canrenone), a renin inhibitor, potassium supplements, a potassium sparing diuretic (e.g., amiloride, triamterene), a potassium binder agent, or angiotensin receptor-neprilysin inhibitor (ARNI) which cannot be discontinued at least 8 weeks prior to the screening visit and during study intervention treatment. 6. Participants currently treated or who were treated with Finerenone (Kerendia©) within 8 weeks prior to the screening visit. 7. Participant with serum/plasma potassium (K+) above 4.8 mmol/L at screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relative change from baseline in UACR at 180 days in combination therapy group versus empagliflozin alone Relative change from baseline in UACR at 180 days in combination therapy group versus finerenone alone | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Relative change in UACR between end of treatment visit and 30 days after end of treatment visit 2. Relative change in UACR between 30 days after end of treatment visit and baseline 3. Relative change in UACR category (>30%, >40%, >50%) at 180 days 4. Ratio of change from baseline in eGFR at 30 days 5. eGFR decline greater than 30% at 30 days from baseline 6. Ratio of change in eGFR at 180 days and 210 days from day 30 7. Number of participants with of AKI events 8. Total number of AKI events 9. Number of participants with hyperkalemia events (moderate hyperkalemia [5.5 6.0 mmol/L]) 10. Total number of hyperkalemia events (moderate hyperkalemia [5.5 6.0 mmol/L]) | — |
Countries
Netherlands
Outcome results
None listed