New kidney pill aims to cut protein leak in diabetics
NCT ID NCT07667517
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether the drug finerenone can reduce protein in the urine (a sign of kidney damage) in adults with type 2 diabetes and chronic kidney disease. About 148 participants will receive either finerenone or a placebo pill daily for 6 months, on top of their usual medications. The main goal is to see if more people on finerenone achieve a meaningful drop in urine protein levels.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- finerenone (a pill that blocks a hormone to protect the kidneys)
- What this could lead to
- If it works, finerenone could become a standard add-on treatment to help slow kidney damage and reduce protein leakage in people with diabetes.
- What could go wrong
- This is a Phase 4 trial with only 148 people, so results may not apply to everyone. Finerenone can raise potassium levels, which requires careful monitoring.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 148 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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, condition, therapy, or uncontrolled concomitant disease that makes the participant unsuitable for the study or unlikely to complete it (e.g., active malignancy or other disease with life expectancy \< 12 months). * 15\. Treatment with a strong CYP3A4 inhibitor (e.g., itraconazole, clarithromycin, ketoconazole, ritonavir, nelfinavir, cobicistat, telithromycin, nefazodone), a strong CYP3A4 inducer (e.g., carbamazepine, phenytoin, phenobarbital, St. John's wort), or a moderate CYP3A4 inducer (e.g., efavirenz) that cannot be discontinued for at least 7 days before randomization. * 16\. Treatment with another mineralocorticoid receptor antagonist (e.g., spironolactone, eplerenone, esaxerenone) or a potassium-sparing diuretic (e.g., amiloride, triamterene) that cannot be discontinued for at least 60 days before the screening visit. * 17\. Biopsy-confirmed non-diabetic kidney disease (e.g., IgA nephropathy). * 18\. Immunosuppressive therapy, or glucocorticoid use by any route other than topical or inhaled, within the past 180 days. * 19\. Participation in another interventional clinical study or use of any investigational product within 90 days before randomization. * 20\. History of alcohol or drug abuse. * 21\. Women of childbearing potential who are pregnant, breastfeeding, intend to become pregnant, or are not using adequate contraception during the study. * 22\. Any other condition deemed by the investigator to make the participant unsuitable for the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
13 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fujian Provincial Hospital
Fuzhou, Fujian, China
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Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
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Nantong First People's Hospital
Nantong, Jiangsu, China
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Sanshui Hospital, Zhujiang Hospital, Southern Medical University
Foshan, Guangdong, China
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Shanghai Municipal Hospital of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, China
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Suzhou Science and Technology City Hospital
Suzhou, Jiangsu, China
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The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
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The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China
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The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
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The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003, China
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The First People's Hospital of Suqian
Suqian, Jiangsu, China
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Xi'an Daxing Hospital
Xi'an, Shaanxi, China
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Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
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