Evaluation of the impact of renal function on the pharmacokinetics of hydroxyurea (Siklos®) in patients with sickle cell disease with normal renal function, with hyperfiltration, or with renal failure. DARH study

Phase 1

• Conditions: Siklos is indicated for the prevention of recurrent painful vaso-occlusive crises including acute chest syndrome in adults, adolescents and children older than 2 years suffering from symptomatic sickle cell syndrome.; MedDRA version: 17.1Level: LLTClassification code 10040643Term: Sickle cell crisisSystem Organ Class: 100000004851; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2014-005033-31-FR
• Lead Sponsor: Addmedica S.A.S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-20
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

a. Age = 18 years.
b. Masculin or feminin sex.
c. Drepanocytose (SS or S-ß0thal) confirmed by hemoglobine electrophorese and genotype of desosxyribonucleic acid (DNA).
d. adhere to national insurance program.
e. Have given their free consent after having been informed of the goals, proceedings, and potential risks .
these criteria will be applied to all 3 groups. The group the subjects will belong to will be defined by the glomerular filtration rate (GFR) estimated using Chronic Kidney Disease EPIdemiology (CKD EPI) cformular without etnic criteria.
Underhydroxyurea (Siklos®) treatment .with stable psology for at least 1 week± 2 jours before inclusion and taken every morning at 9h ± 15 minutes.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 42
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

a. Consent refusal
b. Non observant patient.
c. Having suffered from a vaso-occlusive crisis during the month before inclusion.
d. having undergone tranfusional exchange withiin the 3 months prio to inclusion.
e. Patients participating to anothe study or in exclusion period from a previous study.
f. Patients under diuretics.
g. Patients suffering from an intercurrent illness, particularly inflammatory, non resolved since at least 1 month.
h. Patiente pregnat or breast-feeding.
i. Patients with no or restraint freedom.
j. Patients unable to understand the goal of the study therefore not able to give their consent.
k. if suffering from severe hepatic failure.
l. in case of severe hepatic failure (creatinine clairance < 30
mL/min).
m.Patients presenting toxic signs of myelosuppression.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified