Renal Function in Patients with Thalassemia Major Receiving Exjade® Dispersible Tablets and a New Film-coated Tablet Formulation of Deferasirox (Nanojade®)

Vahid Falahati; Ali Ghasemi; Mohammad Reza Safari; Kazem Ghaffari; Parsa Yousefichaijan; Maryam Zamanian

doi:10.4103/abr.abr_89_21

Renal Function in Patients with Thalassemia Major Receiving Exjade^® Dispersible Tablets and a New Film-coated Tablet Formulation of Deferasirox (Nanojade^®)

Adv Biomed Res. 2022 Oct 27:11:84. doi: 10.4103/abr.abr_89_21. eCollection 2022.

Authors

Vahid Falahati¹, Ali Ghasemi², Mohammad Reza Safari¹, Kazem Ghaffari³, Parsa Yousefichaijan⁴, Maryam Zamanian⁵

Affiliations

¹ Clinical Research Development Center of Amir Kabir Hospital, Arak University of Medical Sciences, Arak, Iran.
² Department of Biochemistry and Hematology, Faculty of Medicine, Semnan University of Medical Sciences, Semnan, Khomein, Iran.
³ Department of Basic and Laboratory Sciences, Khomein University of Medical Sciences, Khomein, Iran.
⁴ Department of Pediatric Nephrology, Arak University of Medical Sciences, Arak, Iran.
⁵ Department of Epidemiology, School of Health, Arak University of Medical Sciences, Arak, Iran.

Abstract

Background: In patients with β-thalassemia major (TM), one of the long-term complications of regular blood transfusion is renal dysfunction. The purpose of the current study was to evaluate the renal function in TM patients receiving Exjade^® dispersible tablets and a new film-coated tablet formulation of deferasirox (Nanojade^®).

Materials and methods: In this descriptive cross-sectional study, a total of 80 TM patients aged 11-48-year-old entered the study. Patients received 20-30 mg/kg/d (single dose) Exjade® (Exjade group, n = 40) and Nanojade® (Nanojade group, n = 40) orally. To evaluated renal function, serum creatinine (S_Cr), estimated glomerular filtration rate (eGFR), blood urea nitrogen (BUN), 24-h urine protein (U_Pro), U_Ca/U_Cr, spot U_Pro/U_Cr ratio, and serum ferritin were calculated at baseline and every 3 months to 9 months.

Results: There was no significant difference in S_Cr, BUN, eGFR, 24-h U_Pro, U_Pro/U_Cr ratio, U_Ca/U_Cr ratio, and serum ferritin between groups at baseline and end of study (P _baseline> 0.05, P _{end of study}> 0.05). There was no significant difference in proteinuria between groups at baseline and end of study (P _baseline> 0.05, P _{end of study}> 0.05).

Conclusions: The proportion of S_Cr, BUN, eGFR, 24-h U_Pro, U_Pro/U_Cr ratio, and U_Ca/U_Cr ratio was not significantly different in TM patients treated with Nanojade^® compared to patients' received Exjade^®. Nanojade^® had similar effects to Exjade^®, and therefore, the use of Nanojade^® is safe in TM patients and does not seem to be associated with increased renal failure, proteinuria, and hypercalciuria.

Keywords: Deferasirox; renal function; thalassemia major.