drugset / Trial / NCT02522104
Evaluation of the Impact of Renal Function on the Pharmacokinetics of SIKLOS ® (DARH)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Hydroxyurea | Other / unclassified | — | — |