drugset / Trial / NCT02522104

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

NCT02522104

Phase 4 Completed 40 enrolled Theravia
Non-randomizedParallel-groupOpen-labelOther

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.

Timeline

Start
2015-09-03
Primary completion
2016-11
Completion
2016-11-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Hydroxyurea Other / unclassified