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New drug may shield kidneys in liver cirrhosis patients

NCT ID NCT07585526

Disease control Sponsor: Institute of Liver and Biliary Sciences, India Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 if the drug finerenone can prevent chronic kidney disease in adults with liver cirrhosis caused by fatty liver disease (MASLD) who also have fluid buildup in the belly (ascites). About 160 participants will receive either finerenone or spironolactone, along with standard care, for 6 months. The main goal is to see which drug better protects kidney function.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 160 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Mar 2028

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 to 80 years

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 \<80years 2. Patient of MASLD/ NAFLD cirrhosis with clinical ascites 3. Stable eGFR-(\>60 ml/min/1.73m2) calculated using MDRD-6 equation: eGFR (ml/min/1.73 m2) = 170 × (Scr)-0.999 × (Age)-0.176 × (0.762 if patient is female) × (1.180 if black) × (SUN)-0.170 × (Albumin)0.318 Exclusion Criteria: 1. Age \<18 years \>80 years 2. K/C/O systemic hypertension. 3. Coagulopathy- INR \>2.5 4. Post TIPS 5. CTP class C 6. Any intrinsic/structural kidney disease. 7. Refractory Ascites 8. Patient with HCC(outside MILAN criteria) or portal vein thrombosis 9. Pregnancy or Lactating mother 10. Receiving cytotoxic therapy, immunosuppressive therapy or other immunotherapy for primary or secondary renal disease within 6 months prior to enrolment 11. Patients with anuria, acute renal failure, or Addison's disease 12. Heart failure (NYHA II to IV) 13. History of hospitalization for hyperkalaemia or acute renal failure induced by previous aldosterone antagonist treatment 14. Ongoing drug or alcohol abuse 15. Uncontrolled type 2 DM ( HbA1C \> 9) 16. MI, unstable angina, stroke or transient ischemic attack (TIA) within 12 weeks prior to enrolment 17. Coronary revascularization (percutaneous coronary intervention \[PCI\] or coronary artery bypass grafting \[CABG\]) or valvular repair/replacement within 12 weeks prior to enrolment or is planned to undergo any of these procedures after randomisation 18. Diagnosed Mixed ascites (additional etiology of ascites apart from portal hypertension) 19. Patients who are on spirinolactone with stable ascites in the past 12 weeks 20. Refusal to give consent

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Conditions

The condition(s) this trial relates to.

chronic renal failure syndrome cirrhosis of liver metabolic dysfunction-associated steatotic liver disease chronic kidney disease prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic kidney diseases MASLD

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. 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

  • Institute of Liver and Biliary Sciences

    New Delhi, National Capital Territory of Delhi, 110070, India

More trials for these conditions

Other studies related to the condition(s) this trial covers.