Finerenone for Regression of Albuminuria in Type 2 Diabetes With Chronic Kidney Disease (NCT07667517) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Finerenone for Regression of Albuminuria in Type 2 Diabetes With Chronic Kidney Disease
China148 participantsStarted 2026-07-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 m\^2, and UACR 30-2000 mg/g (mean of 3 measurements).
* 4\. Serum potassium \<= 5.0 mmol/L.
* 5\. On a maximum tolerated dose of an ACE inhibitor or ARB for at least 90 days.
* 6\. Treatment with an SGLT-2 inhibitor, GLP-1 receptor agonist, or other agents affecting UACR is permitted, but the type and dose must be stable for at least 30 days before screening.
Exclusion Criteria:
* 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.
* 5\. Hepatic impairment (Child-Pugh class C).
* 6\. Blood pressure \> 160/100 mmHg, or systolic blood pressure \< 90 mmHg, at the screening visit.
* 7\. Bilateral renal artery stenosis.
* 8\. Known hypersensitivity to the study drug (active substance or excipients).
* 9\. Treatment with finerenone within 60 days before screening.
* 10\. Stroke, transient ischemic attack, acute coronary syndrome (myocardial infarction, CABG, PCI), or hospitalization for worsening heart failure within 90 days before the screening visit.
* 11\. NYHA class II-IV heart failure.
* 12\. Addison's disease.
* 13\. Gastrointestinal surgery that may affect drug absorption.
* 14\. Any other history…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Albuminuria regression rate
Timeframe: 180 days
Trial details
NCT IDNCT07667517
SponsorFirst Affiliated Hospital of Zhejiang University