NCT07160452Not yet recruitingPhase 4
Levocarnitine for Reducing ESA Requirements in Hemodialysis Patients With Renal Anemia
Effect of Levocarnitine Injections on Reducing Erythropoietin-Stimulating Agent Requirements in Hemodialysis Patients With Renal Anemia
Source: ClinicalTrials.gov · Last updated 12 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Renal anemia is common in people receiving long-term hemodialysis and is usually treated with erythropoiesis-stimulating agents (ESAs). Some patients respond poorly and require high ESA doses, which increases treatment burden, cost, and potential side effects. Carnitine deficiency is frequent in hemodialysis because carnitine is lost during dialysis and its synthesis is reduced. Levocarnitine may improve red blood cell function and reduce the dose of ESA needed to maintain hemoglobin. This single-center, randomized controlled trial will test whether adding intravenous levocarnitine to standard care reduces ESA requirements in adults on maintenance hemodialysis who have renal anemia. Ninety-four participants (age 20-60 years) on thrice-weekly hemodialysis for ≥6 months and with hemoglobin \<10 g/dL will be randomly assigned (1:1) to: Intervention: Levocarnitine 1,000 mg IV three times per week, administered after each dialysis session, plus usual anemia care including ESA per unit protocol. Control: Usual anemia care including ESA per unit protocol without levocarnitine. Participants will be followed for 6 months. Hemoglobin, hematocrit, ESA dose, and the erythropoietin responsiveness index (ERI = monthly ESA dose ÷ \[dry weight × average hemoglobin\]) will be recorded monthly. The primary outcome is the ESA dose (units/week) at month 6. Secondary outcomes include ERI and monthly changes in hemoglobin and hematocrit, along with routine safety monitoring. If levocarnitine lowers ESA needs, the findings may offer a cost-effective strategy to optimize anemia management in hemodialysis patients.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 94 (estimated)
- First submitted
- 30 Aug 2025
- Start date
- 15 Sept 2025
- Primary completion date
- 15 Mar 2026
- Lead sponsor
- Shaikh Zayed Hospital, Lahore
- Diseases
- Chronic kidney disease
- NCT number
- NCT07160452
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 94
- From 15 Sept 2025 to the primary completion date, 15 Mar 2026
- No sites listed in no 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.
Prior treatment
- Patients currently using any carnitine preparation as a supplement (to avoid confounding effects from additional carnitine intake).
- Patients on immunosuppressive drugs, steroids, or antibiotics (to avoid the influence of these medications on anemia and carnitine metabolism).
- Patients who have previously received levocarnitine in either oral or injected form (to eliminate any prior influence of levocarnitine on study outcomes).
Other illness
- Patients with communication difficulties due to dementia or other factors (to ensure accurate symptom reporting and study adherence).
Lab values
- Patients with a history of blood transfusion within the past 6 months (to exclude the immediate impact of transfusions on hemoglobin levels and anemia management).
Other
- Patients with acute inflammation (to prevent interference with study parameters as inflammation can affect anemia status).
Who the study is looking for
- Both male and female patients
- Patients aged 20-60 years.
- Patients undergoing maintenance hemodialysis three times a week for at least six months
- Patients having renal anemia
Age in the registry: 20 years to 60 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.