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

NCT02522104 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-10-12

Study results available
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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

Interventions

DRUG

Siklos

Sponsors & Collaborators

  • Theravia

    lead INDUSTRY

Principal Investigators

  • BARTOLUCCI Pablo, MD · Centre de Référence des Syndromes Drépanocytaires Majeurs, Hôpital Henri-Mondor

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-03
Primary Completion
2016-11-30
Completion
2016-11-28

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02522104 on ClinicalTrials.gov