Levocarnitine for Reducing ESA Requirements in Hemodialysis Patients With Renal Anemia

NCT07160452 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: TERC/SC/INT/2025/455
• Study Type: interventional
• Target: 94
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Anemia; Kidney Failure; End-Stage Renal Disease; Renal Dialysis

Keywords

Levocarnitine; L-carnitine; Erythropoiesis-Stimulating Agents; Erythropoietin Responsiveness Index; Hematocrit

Outcome Measures

Primary Outcomes (1)

• 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.

  Month 6 (plus or minus 2 weeks) after randomization

Secondary Outcomes (1)

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

  Baseline and Month 6 (±2 weeks)

Study Arms (2)

Levocarnitine + Usual ESA Care

EXPERIMENTAL

Adults on maintenance hemodialysis with renal anemia receive levocarnitine 1,000 mg IV immediately after each dialysis session, three times per week for 6 months, in addition to standard anemia management with erythropoiesis-stimulating agents (ESA) per unit protocol. Monthly assessments of hemoglobin, hematocrit, ESA dose, and erythropoietin responsiveness index (ERI).

Drug: Levocarnitine Injection; Other: Usual ESA-Based Anemia Care

Usual ESA Care (No Levocarnitine)

ACTIVE COMPARATOR

Standard anemia management with ESA per unit protocol without levocarnitine. Monthly assessments of hemoglobin, hematocrit, ESA dose, and ERI over 6 months.

Other: Usual ESA-Based Anemia Care

Interventions

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.

Also known as: L-carnitine, Levocarnitine, Carnitine

Levocarnitine + Usual ESA Care

Usual ESA-Based Anemia Care OTHER

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).

Levocarnitine + Usual ESA Care; Usual ESA Care (No Levocarnitine)

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).
• Patients with acute inflammation (to prevent interference with study parameters as inflammation can affect anemia status).
• Patients with communication difficulties due to dementia or other factors (to ensure accurate symptom reporting and study adherence).

Sponsors & Collaborators

• Shaikh Zayed Hospital, Lahore: lead

Related Publications (3)

• Morgans HA, Chadha V, Warady BA. The role of carnitine in maintenance dialysis therapy. Pediatr Nephrol. 2021 Aug;36(8):2545-2551. doi: 10.1007/s00467-021-05101-z. Epub 2021 Jun 18.

  PMID: 34143302 BACKGROUND

• Kadiroglu AK, Yilmaz ME, Sit D, Kara IH, Isikoglu B. The evaluation of postdialysis L-carnitine administration and its effect on weekly requiring doses of rHuEPO in hemodialysis patients. Ren Fail. 2005;27(4):367-72.

  PMID: 16060121 BACKGROUND

• Maruyama T, Higuchi T, Yamazaki T, Okawa E, Ando H, Oikawa O, Inoshita A, Okada K, Abe M. Levocarnitine Injections Decrease the Need for Erythropoiesis-Stimulating Agents in Hemodialysis Patients with Renal Anemia. Cardiorenal Med. 2017 Jun;7(3):188-197. doi: 10.1159/000462983. Epub 2017 Apr 20.

  PMID: 28736559 BACKGROUND

MeSH Terms

Conditions

Anemia; Renal Insufficiency; Kidney Failure, Chronic

Interventions

Carnitine

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals

Central Study Contacts

Hanzla Doctor, M.Phil Pharmacy

CONTACT

00923131614162; hanzlaarshadbutt@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open-label; no parties masked. Primary outcomes (ESA dose, ERI, Hb/Hct) are obtained from routine records.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: Single-center, two-arm, open-label, randomized controlled trial with 1:1 allocation by simple randomization (lottery). Adults on maintenance hemodialysis with renal anemia are assigned to levocarnitine 1,000 mg IV three times weekly after dialysis plus usual ESA care versus usual ESA care without levocarnitine. Follow-up 6 months; monthly assessments of Hb, Hct, ESA dose, and ERI.

Study Record Dates

• First Submitted: August 30, 2025
• First Posted: September 8, 2025
• Study Start: September 15, 2025
• Primary Completion: March 15, 2026
• Study Completion: March 15, 2026
• Last Updated: September 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF
• Time Frame: From 12 months after publication for up to 5 years.
• Access Criteria: Requests with a methodologically sound proposal, protocol, and analysis plan should be directed to the Principal Investigator. Data access will require IRB/ethics approval (if applicable) and a data use agreement.