EUCTR2014-005033-31-FR进行中（未招募）1 期
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
Addmedica S.A.S0 个研究点开始时间: 2015年2月20日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
- •m.Patients presenting toxic signs of myelosuppression.
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