Deferasirox effect on renal haemodynamic parameters in patients with transfusion-dependent β thalassaemia.
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.
Università di Torino, Turin, Italy.
Antonio
A
Piga
Silvia
S
Fracchia
Maria E
ME
Lai
Maria Domenica
MD
Cappellini
Raimund
R
Hirschberg
Dany
D
Habr
Antje
A
Wegener
Emmanuel
E
Bouillaud
Gian Luca
GL
Forni
D000328:Adult; D001565:Benzoates / Q000009:adverse effects / Q000494:pharmacology* / Q000627:therapeutic use; D015415:Biomarkers / Q000097:blood / Q000652:urine; D015913:Chelation Therapy / Q000009:adverse effects / Q000379:methods; D003404:Creatinine / Q000097:blood; D000077588:Deferasirox; D005260:Female; D005293:Ferritins / Q000097:blood; D005919:Glomerular Filtration Rate / Q000187:drug effects; D006439:Hemodynamics / Q000187:drug effects; D006801:Humans; D007502:Iron Chelating Agents / Q000009:adverse effects / Q000494:pharmacology* / Q000627:therapeutic use; D019190:Iron Overload / Q000188:drug therapy / Q000209:etiology; D008297:Male; D008875:Middle Aged; D012079:Renal Circulation / Q000187:drug effects*; D065227:Transfusion Reaction; D014230:Triazoles / Q000009:adverse effects / Q000494:pharmacology* / Q000627:therapeutic use; D055815:Young Adult; D017086:beta-Thalassemia / Q000097:blood / Q000503:physiopathology* / Q000628:therapy
D001565:Benzoates; D015415:Biomarkers; D007502:Iron Chelating Agents; D014230:Triazoles; D005293:Ferritins; D003404:Creatinine; D000077588:Deferasirox
deferasirox; glomerular filtration rate; iron chelation; renal function; thalassaemia