Clinical trial · Interventional
Drug Nephrotoxicity Amelioration by N-acetylcysteine
Drug Nephrotoxicity Amelioration in Hematological Malignancies Patients by N-acetylcysteine
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Drug-Induced Nephropathy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| N Acetylcysteine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- N-acetylcysteine
- description
- amphotericin b (0.5-1.25 mg/kg )over 6-8 hours +NAC 600mg twice daily throughout amphotericin b treatment
- interventionNames
- Drug: N Acetylcysteine
- type
- NO_INTERVENTION
- label
- amphotericin b
- description
- amphotericin b (0.5-1.25mg/kg)over 6-8 hours infusion
Primary outcomes (1)
- measure
- incidence of nephrotoxicity
- timeFrame
- During the intervention
- description
- minimum of 0.3 mg/dL increase in serum creatinine within 48 hours from amphotericin B initiation.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age more than 18 years. * Patients who have indication for systemic (injection) for conventional amphotericin at least 7 days. Exclusion Criteria: * documented acute kidney injury defined by an increase in serum creatinine ‡ 0.3 mg/dl within 48 h, or an increase in serum creatinine by ‡ 1.5 times baseline within the prior 7 days, or urine volume \<0.5 ml/kg/h for 6 h * documented chronic kidney disease (clearance creatinine below 60 ml/min/1.73 m2 calculated by the abbreviated Modification of Diet in Renal Disease equation), history of peritoneal or hemodialysis for \> 3 months * sepsis * Severe hemorrhage(Blood loss \> 3 litres) * Patient with cardiac or chronic liver disease history of receiving AmB by any administration route within the recent 14 days known allergy to either amphotericin b or N-acetylcysteine. * receiving any formulation of NAC within the last week. * unable to tolerate oral intake.
References
Publications (4)
- BACKGROUNDKarimzadeh 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. PMID 26050706
- BACKGROUNDOdabasi 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. PMID 19414577
- BACKGROUNDFeldman 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. PMID 15637469
- DERIVEDEbid 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. PMID 40342610