NCT07108777

L-Carnitine Protective Effect in Nephrotoxicity

Clinical Study to Evaluate the Possible Protective Effect of L-Carnitine Against Cisplatin-Induced Nephrotoxicity

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: Tanta University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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?

Detailed description

Cisplatin is one of the most effective chemotherapeutic agents that has been used for more than 50 years for a different solid Tumers. Nevertheless, its administration is associated with toxicity, including nephrotoxicity which can affects 25-35% of treated patients. 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. Cisplatin nephrotoxicity is also associated with an inflammatory response that plays a significant role in this event. Tumor necrosis factor alpha (TNF- α) is a pleiotropic pro-inflammatory cytokine that signals via TNFRSF1A and TNFRSF1B to activate nuclear factor kappa B (NF-κB) or Mitogen-activated protein kinase (MAPK), eventually leading to cytokine production and/or death signaling. L-carnitine owing to its antioxidant and anti-inflammatory properties has been used as a candidate for nephroprotection against drug induced nephrotoxicity (DIN). L-carnitine significantly ameliorates DIN in animal studies especially against cisplatin-induced renal damage. Inhibition of reactive oxygen species generation, lipid peroxidation, matrix remodeling and apoptosis, anti-inflammatory properties and improvement in carnitine deficiency has been suggested as probable nephroprotective mechanisms of L-carnitine.

Conditions

• Nephrotoxicity

Interventions

Type	Name	Description
DRUG	L-Carnitine Tartrate	L-carnitine 350 mg three times daily by oral.
DRUG	Placebo	placebo tablet three times daily by oral.

Timeline

• Start date: 2025-08-10
• Primary completion: 2026-08-01
• Completion: 2026-11-01
• First posted: 2025-08-07
• Last updated: 2025-08-12

Locations

1 site across 1 country: Egypt