Phase Ib clinical trial of starch-conjugated deferoxamine (40SD02): a novel long-acting iron chelator
Harmatz, P., et al. – For iron chelation, weekly treatment with starch-conjugated deferoxamine (S-DFO), a high-molecular-weight iron chelator with prolonged vascular retention, has the potential to achieve iron balance in the poorly compliant patient.
Methods
- IV infusion of S-DFO into groups of four transfusion-dependent patients with beta-thalassaemia at single doses of 150, 300, 600, 900 mg/kg
- Evaluation of urinary iron excretion and pharmacologic parameters for 1 week and of safety for 3 weeks
Results
- No drug-related effects were observed on clinical chemistries, hematological and coagulation parameters, urinalyses, vital signs, or ECGs
- Drug-related adverse events were limited to four urticarial reactions, none requiring infusion termination
- The drug stimulated clinically significant urinary iron excretion; the 900-mg dose induced iron excretion of 1.31 mg/kg over 1 week with residual iron-biding capacity in plasma for >6 days
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