Deferoxamine Protective Effect in Preventing Nephrotoxicity in Children Under Treatment with Doxorubicin: A Randomized Clinical Trial

Background: Nephrotoxicity secondary to doxorubicin (DOX) may be associated with high morbidity and mortality rates. We aimed to assess the efficacy of Deferoxamine (DFO) in preventing DOX-induced nephrotoxicity in pediatric malignancy. Methods: This Parallel-group randomized clinical trial was done on 62 children aged 2-18 years who had new onset malignancy treated with DOX. They were randomly assigned in three groups; group 1 (no intervention, n=21), group II (DFO 10 times DOX dose, n=20), group III (DFO 50mg/kg, n=21). Patients in the intervention groups received DFO concomitant with DOX 8-hour intravenous infusion in each chemotherapy course. Blood urea nitrogen, serum creatinine, electrolytes, calcium, phosphorus, magnesium and albumin levels, urine microalbumin, urine protein/creatinine ratio, and urine N-acetyl-β-D- glucosaminidase (NAG) as well as findings of kidney ultrasonography were compared between the groups after the last course of chemotherapy. The primary outcome was to compare the radiologic and serologic markers of glomerular and tubular damage between the 3 groups. Results: Sixty patients were analyzed. Patients treated with DFO 10 times the dose of DOX had significantly lower urine NAG level compared to the control group (P=0.032). No significant renal damage was reported in their ultrasonography in the 3 groups. DFO was safely tolerated without any adverse effect. Conclusion: DFO with 10-times the DOX dose may effectively prevent DOX-induced nephrotoxicity at least at the molecular level. Increasing the dose of DFO is not accompanied by better efficacy. Trial registration: IRCT2016021915666N3