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New kidney pill aims to cut protein leak in diabetics

NCT ID NCT07667517

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 148 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    13 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Fujian Provincial Hospital

    Fuzhou, Fujian, China

  • Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong, China

  • Nantong First People's Hospital

    Nantong, Jiangsu, China

  • Sanshui Hospital, Zhujiang Hospital, Southern Medical University

    Foshan, Guangdong, China

  • Shanghai Municipal Hospital of Traditional Chinese Medicine

    Shanghai, Shanghai Municipality, China

  • Suzhou Science and Technology City Hospital

    Suzhou, Jiangsu, China

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, China

  • The First Affiliated Hospital of Ningbo University

    Ningbo, Zhejiang, China

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, China

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003, China

  • The First People's Hospital of Suqian

    Suqian, Jiangsu, China

  • Xi'an Daxing Hospital

    Xi'an, Shaanxi, China

  • Zhongshan Hospital, Fudan University

    Shanghai, Shanghai Municipality, China

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