Clinical Trial

Folate Treatment to Reduce Death Risk in the Year After Infection-Related Acute Kidney Injury

Study acronym: FOL-AKI
Not Yet Recruiting Early Phase 1
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Summary
The goal of this clinical trial is to evaluate if taking folic acid (a form of vitamin B9) can help reduce the risk of death and improve kidney recovery in adults with acute kidney injury (AKI) caused by infections or sepsis. The main question it aims to answer is: Does taking folic acid lower the chance of dying within one year for these patients? This study will also look at other important questions, such as whether folic acid helps kidneys recover faster (within 7 days), prevents long-term kidney problems (progression to chronic kidney disease at 3 months), reduces heart-related events, and is safe. Researchers will compare the group receiving folic acid (5 mg taken by mouth once daily for 90 days, plus usual care) to the group receiving only usual care (standard treatments like fluids, blood pressure control, antibiotics, and stopping harmful medicines) to see if folic acid provides extra benefits. Participants will: 1. Be randomly assigned to one of the two groups 2. Receive usual hospital care for their infection and AKI 3. Take the folic acid (or not, depending on their group) every day for 3 months 4. Have blood tests at the start and at 3 months (including to check serum folate levels) 5. Be followed up for 1 year through clinic visits, phone calls, or medical records to track health outcomes like survival, kidney function, and any side effects This open-label study (both patients and doctors know which treatment is given) will include about 382 adults at Queen Mary Hospital in Hong Kong. It builds on earlier retrospective study data suggesting folic acid might improve survival in similar patients.
Trial Details
NCT Number NCT07377071
Lead Sponsor The University of Hong Kong
Conditions Infection-Associated Acute Kidney Injury
Enrollment 382 participants
Start Date 2026-04-01
Primary Completion 2029-03-31 (estimated)
Study Completion 2029-03-31 (estimated)
Updated on ClinicalTrials.gov 2026-01-29