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Levocarnitine for Reducing ESA Requirements in Hemodialysis Patients With Renal Anemia

Plain-language guide to NCT07160452: phase 4 randomized trial of L-Carnitine, anemia, 94 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT07160452
Phase
phase 4
Status
not yet recruiting
Start
2025-09-15
Completion (planned or actual)
2026-03-15
Participants
94 (estimated)
Design
randomized, open label (everyone knows who gets what), treatment
Conditions studied
Anemia; Kidney Failure; End-Stage Renal Disease; Renal Dialysis
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (phase 4) is built around L-Carnitine for anemia.

Renal anemia is common in people receiving long-term hemodialysis and is usually treated with erythropoiesis-stimulating agents (ESAs).

It had two arms (groups): Levocarnitine + Usual ESA Care (experimental) and Usual ESA Care (No Levocarnitine) (active comparator).

The registry classes the interventions as drug and other.

More on the Plan

Carnitine supports erythrocyte membrane stability and energy metabolism.

Robust, region-specific evidence is limited.

Study follow-up is 6 months, with monthly assessments of laboratory indices and ESA use.

Full eligibility criteria, outcome measures (including the definition of the erythropoietin responsiveness index), intervention details, and visit schedule are specified in the corresponding PRS modules.

Who Took Part

94 planned participants were the target.

It was open to people of any sex aged from 20 years up to 60 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: 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).

How the Study Was Run

Design: randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got L-Carnitine and who got the comparison, which limits bias.

Groups ran in parallel: each of the anemia participants stayed in one arm throughout.

Nothing was hidden in this open-label L-Carnitine study: the anemia participants and staff both knew the treatment.

It started in 2025-09-15 with completion listed for 2026-03-15.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of L-Carnitine in 94 people with anemia.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the L-Carnitine compound page, Anemia research.

Our Notes on the Compound

L-Carnitine: An amino acid derivative that carries fatty acids into mitochondria for energy production.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.