Could an antifungal pill guard the kidneys during heart surgery?
NCT ID NCT07738328
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 208 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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May 2028
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 to 75 years
- 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: * 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.
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The places running it
1 site. 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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Department of Kidney Transplantation, Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Heart attack delay may signal kidney risk after angioplasty
- ICU kidney injury: does the pattern predict lasting damage?
- Can a kidney ultrasound scan warn of kidney damage after heart bypass surgery?
- Two blood tests may separate real kidney harm from a false alarm
- Can watching kidney oxygen during liver surgery keep kidneys safe?