Deferasirox effect on renal haemodynamic parameters in patients with transfusion-dependent β thalassaemia

Antonio Piga, Silvia Fracchia, Maria E. Lai, Maria Domenica Cappellini, Raimund Hirschberg, Dany Habr, Antje Wegener, Emmanuel Bouillaud, Gian Luca Forni

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Abstract

Some patients with β thalassaemia experience non-progressive creatinine increases with deferasirox, mostly within normal limits; the mechanisms involved are not fully elucidated. The effects of deferasirox on renal haemodynamics, including glomerular filtration rate (GFR) and renal plasma flow (RPF), were investigated in a Phase I, open-label study in β thalassaemia major patients with iron overload. Patients received deferasirox 30 mg/kg/d up to Week 8, followed by a 2-week washout period, and extended treatment up to Week 104 with a 4-week washout period. In the short-term study (n = 11), mean GFR and RPF declined from baseline to Week 8 (mean [%] change:-9·2 [-9·5%] and -105·7 ml/min [-17·8%], respectively). A similar pattern was observed during the long-term study (n = 5); mean GFR and RPF decreased up to Week 52 (-19·1 [-17·7%] and -155·6 ml/min [-26·1%]), with similar change at Week 104 (-18·4 [-17·2%] and -115·9 ml/min [-19·6%]). Measures returned to baseline values after each washout. Serum creatinine and creatinine clearance followed a similar pattern. Effects of deferasirox on renal haemodynamics were mild and reversible for up to 2 years of treatment, with no progressive worsening of renal function over time. www.clinicaltrials.gov: NCT00560820.

Original languageEnglish
Pages (from-to)882-890
Number of pages9
JournalBritish Journal of Haematology
Volume168
Issue number6
DOIs
Publication statusPublished - Mar 1 2015

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Keywords

  • Deferasirox
  • Glomerular filtration rate
  • Iron chelation
  • Renal function
  • Thalassaemia

ASJC Scopus subject areas

  • Hematology
  • Medicine(all)

Cite this

Piga, A., Fracchia, S., Lai, M. E., Cappellini, M. D., Hirschberg, R., Habr, D., Wegener, A., Bouillaud, E., & Forni, G. L. (2015). Deferasirox effect on renal haemodynamic parameters in patients with transfusion-dependent β thalassaemia. British Journal of Haematology, 168(6), 882-890. https://doi.org/10.1111/bjh.13217