Chronic kidney disease in type 2 diabetes mellitus MedDRA version: 21.1 Level: LLT Classification code 10045250 Term: Type II diabetes mellitus with renal manifestations System Organ Class: 100000004857
Conditions
Sponsors
Bayer AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 =65 years) yes F.1.3.1 Number of subjects for this age range 207
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 higher than 160/100 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. Please refer to the protocol for a full list of exclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to demonstrate that combination therapy using finerenone and empagliflozin is superior in reducing UACR than either empagliflozin or finerenone alone;Secondary Objective: The secondary outcomes are: - To further investigate the efficacy of combination therapy using finerenone and empagliflozin versus either finerenone or empagliflozin alone. - To evaluate the safety of combination therapy using finerenone and empagliflozin versus either finerenone or empagliflozin alone.;Primary end point(s): 1. Mean ratio of change from baseline to Day 180 in Urinary albumin tocreatinine ratio (UACR) for the combination therapy group, to empagliflozin alone 2. Mean ratio of change from baseline to Day 180 in UACR for the combination therapy group, to finerenone alone.;Timepoint(s) of evaluation of this end point: Up to 180 Days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 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]) Please refer to the protocol for a full list of secondary end points;Timepoint(s) of evaluation of this end point: 1. Up to 210 days 2. Up to 210 days 3. Up to 180 days 4. Up t0 30 days 5. Up to 30 days 6. Up to 210 days 7. to 23. Up to 180 days | — |
Countries
Belgium, Canada, Denmark, France, Germany, Israel, Italy, Japan, Korea, Republic of, Netherlands, Spain, Taiwan, United States
Contacts
Public ContactBayer Clinical Trials Contact
Bayer AG
Outcome results
None listed