Finerenone for Regression of Albuminuria in Type 2 Diabetes With Chronic Kidney Disease
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorFirst Affiliated Hospital of Zhejiang University
About this trial
This is a multicenter, randomized, double-blind, placebo-controlled clinical trial evaluating the efficacy and safety of finerenone, a nonsteroidal mineralocorticoid receptor antagonist, for the early regression of albuminuria in adults with type 2 diabetes mellitus and chronic kidney disease (eGFR \>= 30 mL/min/1.73 m\^2 and UACR 30-2000 mg/g) who are already receiving a maximum tolerated dose of an ACE inhibitor or ARB. A total of 148 participants are randomized 1:1, stratified by baseline UACR (\<300 vs \>=300 mg/g), to oral finerenone (10 or 20 mg once daily, titrated by serum potassium and eGFR) or matching placebo, on top of standard background therapy, for 180 days, followed by a 30-day off-treatment follow-up. Albuminuria regression is defined as both an improvement in Kidney Disease: Improving Global Outcomes albuminuria category, from A3 to A2 or A1, or from A2 to A1, and a more than 30% reduction in urinary albumin-to-creatinine ratio from baseline. The outcome will be reported as the percentage of participants meeting this definition at Day 180.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1. Age >= 18 years at the time of signing informed consent, male or female.
2. Type 2 diabetes mellitus.
3. Chronic kidney disease meeting BOTH of the following: eGFR (CKD-EPI) >= 30 mL/min/1.73 m², and UACR 30-2000 mg/g (mean of 3 measurements).
4. Serum potassium <= 5.0 mmol/L.
Disqualifiers
1. Type 1 diabetes, other specific types of diabetes, or gestational diabetes.
2. HbA1c >= 8.0%.
3. On renal replacement therapy.
4. Acute kidney injury within 180 days before the screening visit.
Trial design
Design model
Parallel
Treatments tested in this trial
Finerenone (BAY 94-8862)
DrugOral finerenone 10 mg or 20 mg once daily, with dose titration by serum potassium and eGFR, for 180 days.
Placebo
DrugMatching placebo tablets, identical in appearance to finerenone, orally once daily, following the same dosing and titration schedule, for 180 days.
Treatment groups
148 Participants
are divided into 2 treatment groupsGroup A: FinerenoneExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Albuminuria regression rate
Proportion of participants achieving albuminuria regression, defined as a reduction in UACR KDIGO albuminuria category (A3 to A2 or A1, or A2 to A1) together with a \>=30% reduction in UACR from baseline.
Time frame
180 daysSecondary outcomes
1
Percent Change From Baseline in Urinary Albumin-to-Creatinine Ratio
Urinary albumin-to-creatinine ratio will be measured in mg/g. Percent change from baseline will be calculated as: (Day 180 UACR - baseline UACR) / baseline UACR × 100%.
Time frame
Baseline and 180 days2
Percentage of Participants With Normoalbuminuria
Normoalbuminuria is defined as urinary albumin-to-creatinine ratio less than 30 mg/g at Day 180.
Time frame
180 days3
Percentage of Participants by UACR Reduction Response Category at Day 180
Percent reduction in urinary albumin-to-creatinine ratio (UACR) from baseline to Day 180 will be calculated for each participant. Participants will be classified into one of four mutually exclusive UACR reduction response categories: no more than 30% reduction, more than 30% to no more than 40% reduction, more than 40% to no more than 50% reduction, and more than 50% reduction. Participants with no reduction or an increase in UACR will be included in the no more than 30% reduction category. The outcome will be reported as the percentage of participants in each response category.
Time frame
Baseline to Day 1804
Percentage of Participants With Improvement in Kidney Disease: Improving Global Outcomes Albuminuria Category at Day 180
Improvement in albuminuria category is defined as a change from A3 to A2 or A1, or from A2 to A1, according to Kidney Disease: Improving Global Outcomes urinary albumin-to-creatinine ratio categories.
Time frame
Baseline to Day 180Other outcomes
1
Percentage of Participants With Adverse Events
The outcome will be reported as the percentage of participants experiencing at least one adverse event from first dose through the end of the 30-day off-treatment follow-up period.
Time frame
From first dose through Day 2102
Percentage of Participants With Serious Adverse Events
The outcome will be reported as the percentage of participants experiencing at least one serious adverse event from first dose through the end of the 30-day off-treatment follow-up period.
Time frame
From first dose through Day 2103
Adverse events of special interest (AESI)
Including change in serum potassium and incidence of hyperkalemia, incidence of eGFR decline \>30% at Day 30, reversibility of eGFR after discontinuation, acute kidney injury, urogenital infection, severe hypoglycemia, symptomatic hypotension, and ketoacidosis
Time frame
Up to 210 days4
Change in Composite MRI-PDFF-derived Peri-organ Visceral Fat Fraction
Abdominal magnetic resonance imaging proton density fat fraction will be used to quantify visceral fat fraction (%) in prespecified perirenal, peripancreatic, and perihepatic regions of interest. A composite peri-organ visceral fat fraction will be calculated for each participant as the arithmetic mean of the region-specific MRI-PDFF values from the perirenal, peripancreatic, and perihepatic regions. The outcome will be reported as the percentage-point change in the composite peri-organ visceral fat fraction from baseline to Day 180.
Time frame
Baseline and 180 daysSponsors and contacts
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Source ClinicalTrials.gov
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