A study to learn how well the treatment combination of finerenone and empagliflozin works and how safe it is compared to each treatment alonein adult participants with long-term kidney disease (chronic kidney disease) and type 2 diabetes

Phase 1

• Conditions: Chronic kidney disease in type 2 diabetes mellitus; MedDRA version: 21.1Level: LLTClassification code 10045250Term: Type II diabetes mellitus with renal manifestationsSystem Organ Class: 10038359 - Renal and urinary disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2021-003037-11-NL
• Lead Sponsor: Bayer AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-03-16
• Last Update Posted: 15 January 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 807

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 <60 mL/min/1.73 m^2 within 3 months or have a registered diagnosis of CKD.
b. In Part B: eGFR 30-90 ml/min/1.73m^2 (with no more than 20% having an eGFR >75 ml/min/1.73m^2) using CKD-EPI formula at screening visit and at least one historical value of eGFR <60 mL/min/1.73 m^2 within 3 months or have a registered diagnostic of CKD.
c. 100 =UACR <5000 mg/g at screening visit (mean value from 3 morning void samples) and documentation of albuminuria/proteinuria (quantitative or semi-quantitative measurement) in the participant's medical records at least 3 months prior to screening
2. Participant with type 2 diabetes (T2D) as defined by the American Diabetes Association (ADA 2021), with glycated hemoglobin (HbA1c) at
screening <11%.
3. Participant treated with the clinically maximum tolerated dose, as per investigator judgment, of angiotensin-converting enzyme inhibitor
(ACEi) or angiotensin receptor blocker (ARB), but not both, for more than 1 month at screening visit.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 600
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 207

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 (Visit 2) higher than 160 SBP or 100 DBP or SBP 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 (central laboratory value).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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:<br>- To further investigate the efficacy of combination therapy using finerenone and empagliflozin versus either finerenone or empagliflozin alone.<br>- 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 to creatinine ratio (UACR) for the combination therapy group, to empagliflozin alone<br>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 Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Relative change in UACR between end of treatment visit and 30 days after end of treatment visit<br>2. Relative change in UACR between 30 days after end of treatment visit and baseline<br>3. Relative change in UACR category (>30%, >40%, >50%) at 180 days<br>4. Ratio of change from baseline in eGFR at 30 days<br>5. eGFR decline greater than 30% at 30 days from baseline<br>6. Ratio of change in eGFR at 180 days and 210 days from day 30<br>7. Number of participants with of AKI events<br>8. Total number of AKI events<br>9. Number of participants with hyperkalemia events (moderate hyperkalemia [5.5 <K+ =6.0 mmol/L], severe hyperkalemia [K+ >6.0<br>mmol/L])<br>10. Total number of hyperkalemia events (moderate hyperkalemia [5.5 <K+ =6.0 mmol/L], severe hyperkalemia [K+ >6.0 mmol/L]);Timepoint(s) of evaluation of this end point: 1. Up to 210 days<br>2. Up to 210 days<br>3. Up to 180 days<br>4. Up t0 30 days<br>5. Up to 30 days<br>6. Up to 210 days<br>7. to 23. Up to 180 days