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Could an antifungal pill guard the kidneys during heart surgery?

NCT ID NCT07738328

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 31, 2026 · Last updated Jul 31, 2026

Summary

This trial tests whether terbinafine, a common antifungal drug, can prevent acute kidney injury in adults undergoing heart surgery with a heart-lung machine. Participants at high risk of kidney damage will receive terbinafine or a placebo before and after surgery. The study tracks kidney function for a week and monitors for complications over 30 days.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Terbinafine, an antifungal drug being repurposed for its antioxidant and anti-inflammatory effects
What this could lead to
If effective, terbinafine could offer a simple, low-cost way to protect kidney function in people undergoing heart surgery, reducing complications and hospital stays.
What could go wrong
This is an early-phase trial, so the drug may not prove effective or safe for this new use. Results from this 208-patient study will need confirmation in larger trials.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 208 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

May 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 75 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: * Aged ≥18 and ≤75 years, without restriction on gender. * Patients with a definite clinical diagnosis scheduled for elective cardiac and macrovascular surgery with cardiopulmonary bypass (CPB) support, including but not limited to coronary artery bypass grafting (CABG), cardiac valve replacement/repair, structural heart disease surgery, aortic arch plasty, or combined procedures of the above surgeries. * Classified as high risk by AKI risk scoring system, with a total score ≥4 points. * The subject or their legal representative shall fully understand the purpose, procedures, potential risks and benefits of this study, and voluntarily sign the written informed consent form. Exclusion Criteria: * Patients with severe chronic renal insufficiency (eGFR \< 50 mL/min/1.73 m² or serum creatinine \> 300 μmol/L), or those receiving any form of renal replacement therapy (e.g., hemodialysis, peritoneal dialysis). * Pre-existing acute kidney injury. * Presence of chronic or active liver diseases, including decompensated liver cirrhosis, active viral hepatitis, autoimmune liver disease, etc.; or preoperative laboratory tests showing ALT/AST ≥ 2 times the upper limit of normal (ULN). * Severe hematological diseases (preoperative white blood cell count \< 3.0 × 10⁹/L, platelet count \< 80 × 10⁹/L). * Uncontrolled active infections, or known immunodeficiency disorders (e.g., HIV infection, status post organ transplantation). * History of severe hypersensitivity to terbinafine or any excipients of its formulation. * Pregnant or lactating women, as well as women of childbearing potential who plan to conceive during the study and refuse to use effective contraception. * Participation in any other clinical trial of investigational drugs or medical devices within 3 months prior to screening. * Patients deemed inappropriate for enrollment in this study at the investigator's clinical discretion.

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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

    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

  • Department of Kidney Transplantation, Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, 510080, China

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