Terbinafine for CSA-AKI Prevention

NCT07738328 | Not Yet Recruiting Phase 2

• 1 other identifier: KY2026-378-02
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Kidney Injury; Cardiac Surgical Procedures

Keywords

Acute Kidney Injury; Cardiac Surgery-Associated Acute Kidney Injury; Terbinafine; Randomized

Outcome Measures

Primary Outcomes (1)

• Incidence of CSA-AKI at 7 Days Post-Surgery

  Defined according to KDIGO criteria: SCr increase ≥26.5 μmol/L within 48h, or SCr increase ≥1.5× baseline within 7d, or urine output \<0.5 mL/kg/h for ≥6h.

  From day of surgery through postoperative day 7

Secondary Outcomes (8)

• Maximum KDIGO Stage of AKI Within 7 Days Post-Surgery

  From day of surgery through postoperative day 7

• Use of Renal Replacement Therapy Within 30 Days Post-Surgery

  Within 30 days post-surgery

• Duration of ICU stay and total hospital length of stay

  Postoperative day of ICU discharge (varies, captured at the time of discharge) and postoperative day of hospital discharge (varies, captured at the time of discharge) - with data reported as cumulative days up to 30 days for ICU and up to 60 days for hos

• Major adverse cardiovascular events within 30 days (MACE30)

  Within 30 days post-surgery

• Major adverse kidney events within 30 days (MAKE30)

  Within 30 days post-surgery

Other Outcomes (3)

• Cardiac troponin T (cTnT), creatine kinase-MB (CK-MB), and N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels

  Pre-surgery (baseline), 24 hours post-surgery, 48 hours post-surgery, and 72 hours post-surgery

• Serum concentrations of IL-6, CRP, Cystatin C, MDA, TXB₂, and HSP70

  At baseline (immediately before surgery), at 6 hours after the end of surgery, and at 24 hours after the end of surgery

• Urinary concentrations of NGAL and KIM-1 (renal tubular injury biomarkers)

  Baseline (prior to surgery), 6 hours after surgery, 24 hours after surgery, and 48 hours after surgery

Study Arms (2)

Terbinafine group

EXPERIMENTAL

Matching placebo tablets, orally, once daily for 5 days, starting 1 day before surgery and continuing through postoperative day 3.

Drug: Terbinafine

Control group

NO INTERVENTION

Standard of Care

Interventions

Terbinafine DRUG

Terbinafine, an allylamine antifungal agent, is being repurposed for its potential antioxidant and anti-inflammatory properties to prevent acute kidney injury following cardiac surgery

Terbinafine group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead

Study Sites (1)

Department of Kidney Transplantation, Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Terbinafine

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Central Study Contacts

Qiquan Sun, Professor

CONTACT

+86 13825109488; sunqiquan@gdph.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician, Professor

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: July 31, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)