Levocarnitine for Reducing ESA Requirements in Hemodialysis Patients With Renal Anemia

ConditionsAnemia Kidney Failure End-Stage Renal Disease Renal Dialysis

Trial statusNot yet recruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age20-60

SponsorShaikh Zayed Hospital, Lahore

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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).

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).

Trial design

Design model

Parallel

Treatments tested in this trial

Levocarnitine Injection
Drug
1,000 mg levocarnitine IV (slow IV push or infusion per unit policy) post-hemodialysis, three times weekly for 6 months (\~72 doses). Administered in the dialysis unit in addition to usual ESA-based anemia care.
Usual ESA-Based Anemia Care
Other intervention
Standard-of-care anemia management using recombinant human erythropoietin (ESA) per unit protocol. Typical initial dosing: 50-100 U/kg/week if Hb \<10 g/dL (in 2-3 doses/week); 50 U/kg/week if Hb 10-11 g/dL; 25-50 U/kg/week as maintenance if Hb 11-12 g/dL. ESA dose adjusted monthly using ERI and Hb/Hct targets (generally Hb 10-12 g/dL).

Treatment groups

94 Participants

are divided into 2 treatment groups

Group A: Levocarnitine + Usual ESA CareExperimental treatment 2 interventions

Group B: Usual ESA Care (No Levocarnitine)Active comparator 1 intervention

Trial outcomes

Primary outcomes

Weekly ESA dose at Month 6 (units/week)

Total weekly dose of erythropoiesis-stimulating agent (ESA; recombinant human erythropoietin or biosimilar) abstracted from the dialysis unit medication administration record. Recorded as the sum of ESA units administered in the 7-day period closest to the Month-6 visit. Lower values indicate an ESA-sparing effect.

Time frame

Month 6 (plus or minus 2 weeks) after randomization

Secondary outcomes

Change in weekly ESA dose from Baseline to Month 6 (units/week)

Difference = (Month-6 weekly ESA dose) - (Baseline weekly ESA dose), from medication records. Negative values indicate dose reduction.

Time frame

Baseline and Month 6 (±2 weeks)

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shaikh Zayed Hospital, Lahore

Lead sponsor

Source ClinicalTrials.gov

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