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L-Carnitine Protective Effect in Nephrotoxicity
Plain-language guide to NCT07108777: phase 2 randomized trial of L-Carnitine, 46 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT07108777
- Phase
- phase 2
- Status
- recruiting participants
- Start
- 2025-08-10
- Completion (planned or actual)
- 2026-08-01
- Participants
- 46 (estimated)
- Design
- randomized, double-blind, prevention
- Conditions studied
- Nephrotoxicity
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 2 trial, researchers set out to test L-Carnitine.
The goal of this clinical trial is to assess the possible reno-protective effect of L-carnitine against cisplatin-induced nephrotoxicity in patients receiving cisplatin-based chemotherapy.
The main question it aims to answer is: Does L-carnitine have the ability to protect the kidney against cisplatin-induced nephrotoxicity?
It had two arms (groups): L-carnitine group (active comparator) and Placebo group (placebo comparator).
The registry classes the interventions as drug.
More on the Plan
Cisplatin nephrotoxicity mainly explained by accumulation in the renal tubules mostly in the proximal and distal tubules where it inhibits and alters the expression pattern of several membrane transporters and water channels and inhibits mitochondrial function and ATP production, thus generating oxidative stress.
L-carnitine owing to its antioxidant and anti-inflammatory properties has been used as a candidate for nephroprotection against drug induced nephrotoxicity (DIN).
Who Took Part
46 planned participants were the target.
It was open to people of any sex aged from 18 years up to 75 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Male or female patients. Newly diagnosed patients with cancer and with an indication for cisplatin - based chemotherapy. Age between 18 and 75 years. No serious cardiopulmonary comorbidity which could impair involvement in the study. Patients who will scheduled to receive at least 3 cycles of cisplatin.
The full record lists 7 inclusion and 10 exclusion criteria; among the exclusions: pregnancy or lactation; metastasis to the central nervous system; psychiatric disorders.
How the Study Was Run
It was run as a randomized, parallel-group and double-blind study.
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 participants stayed in one arm throughout.
Blinding on both sides kept the participants and researchers unaware of who received L-Carnitine.
Those kept unaware of assignments: participant and care provider.
It started in 2025-08-10 with completion listed for 2026-08-01.
It ran at 1 site in Egypt.
Its stated primary purpose is prevention.
What Was Measured
The main thing measured (primary outcome): change in serum creatinine and creatinine clearance (time frame: Baseline (before chemotherapy cycles)).
What This Means in Plain Language
Put simply, this is a phase 2, randomized trial of L-Carnitine in 46 people.
It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the L-Carnitine compound page, all human trials.
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.