Terbinafine for CSA-AKI Prevention

Starting soon · Phase 2

Conditions studied: Acute Kidney Injury, Cardiac Surgical Procedures

In brief

Primary Objective: To evaluate the efficacy and safety of perioperative oral terbinafine in reducing the incidence of cardiac surgery-associated acute kidney injury (CSA-AKI).Secondary Objectives:To assess the effects of terbinafine on the severity of post-cardiac surgery AKI, length of hospital stay, and 30-day major adverse kidney events (MAKE30);To evaluate its impacts on biomarkers of renal injury and inflammation.

Key facts

Study ID

NCT07738328

Run by

Guangdong Provincial People's Hospital

People needed

208

Starts

2026-09-01

Expected to finish

2028-05-01

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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