Conditions: Renal Impairment
Keywords: Renal Impairment Kidney Impairment Kidney Disease Ferriprox Deferiprone DFP (deferiprone) L1
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 32
Healthy volunteers: yes

Brief summary:
Multi-center, non-randomized, open-label, single-dose, parallel group study to determine the effect of impaired renal function on the PK of deferiprone and its 3-O-glucuronide metabolite following a single oral dose of 33mg/kg Ferriprox®.

Detailed description:
Post-marketing study to evaluate the effect of impaired renal function on the pharmacokinetics (PK) of deferiprone and its 3-O-glucuronide metabolite and on the safety of Ferriprox® in subjects with mild, moderate and severe renal impairment as compared to healthy volunteers.

Arms:
arm 1: Healthy volunteers, defined as having an estimated glomerular filtration rate (eGFR) ≥90 mL/min/1.73m\^2. All subjects received a single 33 mg/kg oral dose of deferiprone. arm 2: Mild impairment, defined as having an eGFR 60-89 mL/min/1.73m\^2. All subjects received a single 33 mg/kg oral dose of deferiprone. arm 3: Mild impairment, defined as having an eGFR 30-59 mL/min/1.73m\^2. All subjects received a single 33 mg/kg oral dose of deferiprone. arm 4: Severe impairment, defined as having an eGFR 15-19 mL/min/1.73m\^2. All subjects received a single 33 mg/kg oral dose of deferiprone.

Interventions: intervention 1: Deferiprone
Intervention descriptions: intervention 1: Oral iron chelator

Protocol document: