A parallel-group treatment, Phase 2, double-blind, three-arm study to assess efficacy and safety of finerenone plus empagliflozin compared with either finerenone or empagliflozin in participants with chronic kidney disease and type 2 diabetes
- Conditions
- Chronic Kidney Disease and Diabetes type 210012653
- Registration Number
- NL-OMON53849
- Lead Sponsor
- Bayer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 35
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
<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.
2b:
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Relative change from baseline in UACR at 180 days in combination therapy group<br /><br>versus empagliflozin alone<br /><br><br /><br>Relative change from baseline in UACR at 180 days in combination therapy group<br /><br>versus finerenone alone</p><br>
- Secondary Outcome Measures
Name Time Method <p>1. Relative change in UACR between end of treatment visit and 30 days after end<br /><br>of treatment visit 2. Relative change in UACR between 30 days after end of<br /><br>treatment visit and baseline 3. Relative change in UACR category (>30%, >40%,<br /><br>>50%) at 180 days 4. Ratio of change from baseline in eGFR at 30 days 5. eGFR<br /><br>decline greater than 30% at 30 days from baseline 6. Ratio of change in eGFR at<br /><br>180 days and 210 days from day 30 7. Number of participants with of AKI events<br /><br>8. Total number of AKI events 9. Number of participants with hyperkalemia<br /><br>events (moderate hyperkalemia [5.5 6.0 mmol/L]) 10. Total number of<br /><br>hyperkalemia events (moderate hyperkalemia [5.5 6.0 mmol/L])</p><br>