Conditions: Sickle Cell Disease Renal Function Disorder
Keywords: Pharmacokinetics of Hydroxyurea
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 40
Healthy volunteers: no

Brief summary:
The use of hydroxyurea in sickle cell disease patients with glomerular hyperfiltration and renal failure requires a specific monitoring and dose adjustment in order to remain within the therapeutic interval while limiting the risk of toxicity or therapeutic failure. For this reason the investigators propose to compare the pharmacokinetic parameters of hydroxyurea in normal-renal function sickle cell patients to those of patients with glomerular hyperfiltration or moderate renal failure.

Detailed description:

Arms:
arm 1: Normal-renal function: 90 ≤ GFR ≤ 130 mL/min/1.73m2 in women or 140 mL/min/1.73m2 in men arm 2: Glomerular renal hyperfiltration: GFR \> 130 mL/min/1.73m2 in women and GFR \> 140 mL/min/1.73m2 in men. arm 3: Moderate renal failure: 30 ≤ GFR ≤ 60 mL/min/1.73m2

Interventions: intervention 1: Siklos
Intervention descriptions: intervention 1: None

Protocol document: