EUCTR2006-006838-17-IT进行中（未招募）不适用
Phase I study to examine the effect of deferasirox on renal hemodynamics in β-thalassemia patients with transfusional iron overload - ND
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 8
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
- •Male or female patients >= 18 years of age without prior history of deferasirox treatment β-thalassemia patients receiving regular transfusions every 2-5 weeks leading to iron intake equal or greater than 0.25 mg/kg/day Transfusion history of >= 20 units of packed red blood cells Serum ferritin values >= 500 µg/L or LIC >= 2 mg/kg of dry weight as measured by SQUID at baseline
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Creatinine above the upper limit of normal range at screening Urine protein/creatinine ratio of > 0.5 mg/mg at screening ALT greater than 5 x ULN at screening History of nephrotic syndrome History of relevant ocular or auditory toxicity related to iron chelation History of HIV positivity History of hypertension, diabetes, hypoproteinemia, obesity Patients with a surgical or medical condition that might significantly alter the absorption, distribution, metabolism or excretion of deferasirox or study agents used to measure GFR and RFP at screening Allergy or contraindication to the administration of deferasirox, 51CR-EDTA or 123I-Hippuran Any disease that would prevent the patient from undergoing study treatment and study procedures (including providing informed consent) History of drug or alcohol abuse within the 12 months prior to enrollment Patients treated with systemic investigational drug within 4 weeks prior or with topical investigational drug within 7 days prior to the screening visit Patients with underlying cardiac disease requiring continuous iron chelation therapy Treatment with drugs that may affect renal parameters (i.e, ACE inhibitors, cyclosporine, etc) Pregnant or breast feeding patients Sexually active pre-menopausal female patients without adequate contraception. Female patients must use double-barrier contraception, oral contraceptive plus barrier contraceptive, or must have undergone clinically documented total hysterectomy and/or oophorectomy, tubal ligation or be postmenopausal defined by amenorrhea for at least 12 months. Inability to comply with all study related procedures, medications and evaluations
研究者
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