Acute Kidney InjuryPhase 2NCT07738328
Terbinafine for CSA-AKI Prevention
A Phase 2 study testing Terbinafine in people with Acute Kidney Injury and Cardiac Surgical Procedures, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Kidney Injury, Cardiac Surgical Procedures
- What is being tested?
- Terbinafine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2026to 1 May 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Department of Kidney Transplantation, Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080
Qiquan Sun, +86 13825109488, suqiquan@gdph.org.cn
About this study
Official title: Terbinafine for the Prevention of Cardiac Surgery-Associated Acute Kidney Injury: A Randomized Controlled Trial
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
- Being tested
- Terbinafine
- Keywords
- Acute Kidney Injury, Cardiac Surgery-Associated Acute Kidney Injury, Terbinafine, Randomized
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TerbinafineDrug
Terbinafine, an allylamine antifungal agent, is being repurposed for its potential antioxidant and anti-inflammatory properties to prevent acute kidney injury following cardiac surgery
| Study group | Role | What they receive |
|---|---|---|
| Terbinafine group | Experimental | Matching placebo tablets, orally, once daily for 5 days, starting 1 day before surgery and continuing through postoperative day 3. Receives: Drug: Terbinafine |
| Control group | No intervention | Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From day of surgery through postoperative day 7
Secondary outcomes (8)
Maximum KDIGO Stage of AKI Within 7 Days Post-Surgery
AKI severity is assessed by the maximum KDIGO stage within 7 days post-surgery, based on serum creatinine and urine output criteria. Stage 1: SCr increase ≥26.5 μmol/L within 48h, or increase to 1.5-1.9× baseline within 7d, or urine output <0.5 mL/kg/h for 6-12h; Stage 2: SCr increase to 2.0-2.9× baseline, or urine output <0.5 mL/kg/h for ≥12h; Stage 3: SCr increase to ≥3.0× baseline, or SCr ≥353.6 μmol/L, or initiation of RRT, or urine output <0.3 mL/kg/h for ≥24h, or anuria for ≥12h. The highest stage reached within the 7-day period is recorded.
Measured: From day of surgery through postoperative day 7
Use of Renal Replacement Therapy Within 30 Days Post-Surgery
Documentation of whether the subject received any form of renal replacement therapy (including continuous renal replacement therapy, intermittent hemodialysis, peritoneal dialysis, etc.) within 30 days after surgery, based on clinical orders and treatment records. Binary outcome: yes/no.
Measured: Within 30 days post-surgery
Duration of ICU stay and total hospital length of stay
Data obtained from the hospital electronic medical record system or inpatient records. ICU stay is defined as the total number of days the subject spent in the ICU post-surgery (from ICU admission after surgery to ICU discharge). Total hospital length of stay is defined as the total number of days of hospitalization post-surgery (from the day of surgery to hospital discharge).
Measured: 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)
Data obtained from electronic medical records. MACE30 is defined as all-cause death, nonfatal myocardial infarction, or nonfatal stroke within 30 days post-surgery
Measured: Within 30 days post-surgery
Major adverse kidney events within 30 days (MAKE30)
Data obtained from electronic medical records. MAKE30 is defined as all-cause death, new RRT (any modality), or ≥25% decline in eGFR from baseline within 30 days post-surgery. eGFR is calculated using the CKD-EPI formula; baseline is defined as the most recent pre-operative value.
Measured: Within 30 days post-surgery
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels
Peripheral venous blood samples are collected and sent to the central laboratory for serum ALT and AST measurement using an automated biochemical analyzer. Normal reference ranges and assay methods follow each center's standard operating procedures.
Measured: Pre-surgery (baseline), postoperative day 1, day 3, and day 7 or at hospital discharge, whichever came first.
Blood cell counts, including white blood cell count (WBC), red blood cell count (RBC), and platelet count (PLT)
Peripheral venous blood samples are collected and measured using an automated hematology analyzer
Measured: Postoperative day 1, day 3, and day 7 or at hospital discharge, whichever came first.
Incidence of adverse events, including dysgeusia, rash, and gastrointestinal reactions (nausea, vomiting, diarrhea, abdominal pain, etc.)
Adverse events are recorded based on investigator inquiry and subject self-report, including event name, onset time, severity, duration, outcome, and causality with the study drug. Severity is graded according to CTCAE 5.0 criteria (Grade 1-5), and causality with the study drug is determined by the investigator
Measured: From post-surgery to discharge (within 30-day follow-up period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Apr 2028 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qiquan Sun, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07738328
- Sponsor's protocol ID
- KY2026-378-02
- Status last verified
- Jul 2026
- First submitted
- 20 Jul 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Terbinafine for the Prevention of Cardiac Surgery-Associated Acute Kidney Injury: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07738328
- Acronym / sponsor ID
- KY2026-378-02
- Conditions
- Acute Kidney Injury, Cardiac Surgical Procedures
- Keywords
- Acute Kidney Injury, Cardiac Surgery-Associated Acute Kidney Injury, Terbinafine, Randomized
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 31 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Terbinafine group | Experimental | Drug: TerbinafineMatching placebo tablets, orally, once daily for 5 days, starting 1 day before surgery and continuing through postoperative day 3. |
| Control group | No intervention | –Standard of Care |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TerbinafineTerbinafine, an allylamine antifungal agent, is being repurposed for its potential antioxidant and anti-inflammatory properties to prevent acute kidney injury following cardiac surgery | Drug | Terbinafine group |
Primary outcome
Incidence of CSA-AKI at 7 Days Post-Surgery
Time frame: From day of surgery through postoperative day 7
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.
8 secondary outcomes
Maximum KDIGO Stage of AKI Within 7 Days Post-Surgery
Time frame: From day of surgery through postoperative day 7
Use of Renal Replacement Therapy Within 30 Days Post-Surgery
Time frame: Within 30 days post-surgery
Duration of ICU stay and total hospital length of stay
Time frame: 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)
Time frame: Within 30 days post-surgery
Major adverse kidney events within 30 days (MAKE30)
Time frame: Within 30 days post-surgery
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels
Time frame: Pre-surgery (baseline), postoperative day 1, day 3, and day 7 or at hospital discharge, whichever came first.
Blood cell counts, including white blood cell count (WBC), red blood cell count (RBC), and platelet count (PLT)
Time frame: Postoperative day 1, day 3, and day 7 or at hospital discharge, whichever came first.
Incidence of adverse events, including dysgeusia, rash, and gastrointestinal reactions (nausea, vomiting, diarrhea, abdominal pain, etc.)
Time frame: From post-surgery to discharge (within 30-day follow-up period)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Terbinafine in people with Acute Kidney Injury and Cardiac Surgical Procedures, run by Guangdong Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qiquan Sun, Professor (+86 13825109488, sunqiquan@gdph.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of CSA-AKI at 7 Days Post-Surgery (time frame: From day of surgery through postoperative day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.