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

Information source: ADDMEDICA SASA
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Sickle Cell Disease; Renal Function Disorder

Intervention: Siklos (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: ADDMEDICA SASA

Official(s) and/or principal investigator(s):
BARTOLUCCI Pablo, MD, Principal Investigator, Affiliation: Centre de Référence des Syndromes Drépanocytaires Majeurs, Hôpital Henri-Mondor

Overall contact:
DUGUET Corinne, MD, Phone: +33 1 72 69 01 86, Email: corinne.duguet@addmedica.com

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.

Clinical Details

Official title: 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)

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Primary outcome:

Measure of plasmatic data: maximum concentration (Cmax)

Measure of plasmatic data: minimum concentration (Cmin)

Measure of plasmatic data: time to obtain the maximum concentration (Tmax)

Measure of plasmatic data: area under the curve (AUC0-24)

Measure of plasmatic data: elimination half-life (T½)

Measure of plasmatic data: total clearance (Cl tot)

Measure of plasmatic data: distribution volume

Measure of urinary data: hydroxyurea urinary fractions

Measure of urinary data: renal clearance (Cl renal).

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Age ≥ 18 years.

- Male or female.

- Sickle cell disease (SS or S-β0thal) confirmed by haemoglobin electrophoresis and

genotyping by deoxyribonucleic acid (DNA) analysis.

- Affiliation to a social security system.

- Having freely consented in writing after being informed of the objective, programme

and potential risks incurred. These criteria will apply to the 3 groups of sickle cell disease patients according to the renal function stage defined by the glomerular filtration rate (GFR) estimated by the formula of the Chronic Kidney Disease EPIdemiology (CKD EPI) collaboration without ethnic criterion:

- Normal-renal function: 90 ≤ GFR ≤ 130 mL/min/1. 73m2 in women or 140 mL/min/1. 73m2 in

men.

- Moderate renal failure: 30 ≤ GFR ≤ 60 mL/min/1. 73m2.

- Glomerular renal hyperfiltration: GFR > 130 mL/min/1. 73m2 in women and GFR > 140

mL/min/1. 73m2 in men.

- Treated with hydroxyurea (Siklos®) with a stable dosage for at least one week ±

2 days before inclusion in the study and dose administered in the morning at 9: 00 ± 15 minutes. Exclusion Criteria:

- Refusal to consent.

- Patients that do not comply.

- Occurrence of vaso-occlusive crisis in the month prior to the inclusion in the study.

- Patients having had an exchange transfusion in the 3 months before inclusion in the

study.

- Patients participating in another clinical trial or in the exclusion period of a

previous clinical trial.

- Patients treated with a diuretic.

- Patients with an intercurrent disorder, especially inflammatory, that has not

recovered for at least one month.

- Pregnant or breast-feeding women.

- Patients deprived of liberty or under legal protection.

- Patients who cannot understand the objective and the course of the study, incapable

of giving their consent.

- In the event of severe hepatic failure.

- In the event of severe renal failure (creatinine clearance < 30 ml/min).

- Patients who show toxic signs of bone marrow suppression.

Locations and Contacts

DUGUET Corinne, MD, Phone: +33 1 72 69 01 86, Email: corinne.duguet@addmedica.com

Additional Information

Starting date: September 2015
Last updated: August 11, 2015

Page last updated: August 23, 2015

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