NCT02522104

Evaluation of the Impact of Renal Function on the Pharmacokinetics of SIKLOS ® (DARH)

Evaluation of the Impact of Renal Function on the Pharmacokinetics of Hydroxyurea (SIKLOS ®) in Normal-renal Function, Hyperfiltrating and Renal Failure Sickle Cell Disease Patients (DARH)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Theravia · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sickle Cell Disease
• Renal Function Disorder

Interventions

Type	Name	Description
DRUG	Siklos

Timeline

• Start date: 2015-09-03
• Primary completion: 2016-11-01
• Completion: 2016-11-28
• First posted: 2015-08-13
• Last updated: 2021-10-12
• Results posted: 2021-08-27

Locations

1 site across 1 country: France