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

Some patients with 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 thalassaemia major patients with iron overload. Patients received deferasirox 30mg/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:-92 [-95%] and -1057ml/min [-178%], respectively). A similar pattern was observed during the long-term study (n=5); mean GFR and RPF decreased up to Week 52 (-191 [-177%] and -1556ml/min [-261%]), with similar change at Week 104 (-184 [-172%] and -1159ml/min [-196%]). 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 2years of treatment, with no progressive worsening of renal function over time. : NCT00560820.