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

Sickle Cell Disease Clinical Trial

Official title:
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)

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02522104
Study type Interventional
Source ADDMEDICA SASA
Contact
Status Completed
Phase Phase 4
Start date September 3, 2015
Completion date November 28, 2016
View Details
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