At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 40 enrolled
Drug / intervention
Siklosdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 4 clinical trial evaluating Siklos for Sickle Cell Disease and Renal Function Disorder. Completed, enrolled 40 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSickle Cell Disease, Renal Function Disorder
CountriesFrance
Collaborators--
Timeline
Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 2015
Enrollment StartSep 2015
Primary CompletionNov 2016
Study CompletionNov 2016
TodayJul 2026
First PostedAug 13, 2015
Enrollment StartSep 3, 2015
Primary CompletionNov 1, 2016
Study CompletionNov 28, 2016
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 10.9 years ago
Interventions
Siklosdrug