NCT07377071Not yet recruitingEarly phase 1
Folate Treatment to Reduce Death Risk in the Year After Infection-Related Acute Kidney Injury
Impact of Folate Administration on One-Year Mortality in Patients With Infection-Associated Acute Kidney Injury: An Open-Label Randomised Controlled Study
Source: ClinicalTrials.gov · Last updated 29 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 382 (estimated)
- First submitted
- 14 Jan 2026
- Start date
- 1 Apr 2026
- Primary completion date
- 31 Mar 2029
- Lead sponsor
- The University of Hong Kong
- Diseases
- Chronic kidney disease
- NCT number
- NCT07377071
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 382
- From 1 Apr 2026 to the primary completion date, 31 Mar 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients will be excluded from the study if any of the following conditions is present.
- Patients with AKI due to causes not related to infections or sepsis (e.g., nephrotoxic drugs, obstruction of urinary flow)
- Known hypersensitivity or contraindication to folate (folic acid)
Other
- Pregnancy or breastfeeding women
- Already on folate treatment at the time of screening
Who the study is looking for
- Patients will be eligible for the study if ALL the following are present:
- Adults ≥18 years of age
- Presence of an infection (defined by clinical signs/symptoms such as fever, chills, or laboratory evidence; or presumed infection indicated by blood culture obtained and at least 4 Qualifying Antimicrobial Days starting within 2 calendar days before/after blood culture; or physician's judgment)
- Diagnosed with AKI based on KDIGO criteria: increase in serum creatinine by ≥0.3 mg/dL (26.5 µmol/L) within 48 hours, OR increase to ≥1.5 times baseline, OR urine output \<0.5 mL/kg/h for ≥6 hours (baseline creatinine is the median from 8-365 days prior, or lowest from 0-7 days if unavailable)
- Ability to provide informed consent or having a legally authorized representative to provide consent
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Queen Mary Hospital Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.