drugset / Trial / NCT06122311
Drug Nephrotoxicity Amelioration by N-acetylcysteine
RandomizedParallel-groupOpen-labelPrevention
Summary
When treating individuals with febrile neutropenia, amphotericin B (AmB-d) is one of the most effective treatments against often fatal systemic fungal infections.Nephrotoxicity from amphotericin B can develop with an incidence of up to 80.This emphasizes the value of nephroprotectant agent use.Because of N-acetylcysteine's antioxidant, antiapoptotic, vasodilator properties and its therapeutic effects on contrast nephropathy. Acetylcysteine's impact on amphotericin B-induced nephrotoxicity in cancer patients is assessed.
Timeline
- Start
- 2023-08-25
- Primary completion
- 2024-06-10
- Completion
- 2024-06-10
Publications
- Background Karimzadeh I, Khalili H, Sagheb MM, Farsaei S. A double-blinded, placebo-controlled, multicenter clinical trial of N-acetylcysteine for preventing amphotericin B-induced nephrotoxicity. Expert Opin Drug Metab Toxicol. 2015;11(9):1345-55. doi: 10.1517/17425255.2015.1042363. Epub 2015 Jun 11.
- Background Odabasi Z, Karaalp A, Cermik H, Mohr J, Tigen ET, Koc M, Korten V. Reduction of amphotericin B-induced renal tubular apoptosis by N-acetylcysteine. Antimicrob Agents Chemother. 2009 Jul;53(7):3100-2. doi: 10.1128/AAC.00001-09. Epub 2009 May 4.
- Background Feldman L, Efrati S, Dishy V, Katchko L, Berman S, Averbukh M, Aladjem M, Averbukh Z, Weissgarten J. N-acetylcysteine ameliorates amphotericin-induced nephropathy in rats. Nephron Physiol. 2005;99(1):p23-7. doi: 10.1159/000081799.
- Ebid AIM, Mohamed HS, Mohammed YMM, Mohamed Abdel Motaleb SM. Efficacy, Safety, and Cost-Effectiveness of N-Acetylcysteine in Preventing Amphotericin B Nephrotoxicity in Egyptian Patients with Hematological Malignancies: A Randomized Controlled Trial. Hosp Pharm. 2025 May 6;60(5):461-471. doi: 10.1177/00185787251337615. eCollection 2025 Oct.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | N-acetylcysteine | Small molecule | 600 mg | Oral |
Indications
No indication recorded.