EUCTR2007-002378-68-ES进行中（未招募）不适用
Estudio piloto de Selección de la Inmunosupresión basado en un régimen basado en inhibidores de CNI o libre de CNI dependiendo de la aloreactividad donante-especifica mediante el ensayo ELISPOT en receptores de un injerto renal e bajo riesgo - SIRES
SERVICIO NEFROLOGIA HOSPITAL BELLVITGE0 个研究点开始时间: 2007年10月24日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 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
- •1.Age of donor and recipient between 18 and 65 years.
- •2.End-stage renal disease and scheduled to receive a primary or secondary renal allograft from a cadaveric, a living-unrelated, or a living-related donor. Patients scheduled for a second transplant must have maintained their primary graft for at least 6 months after transplantation, with the exception of graft failure due to technical reasons.
- •3.PRA = 20%
- •4.Negative cytotoxic T-cell cross-match.
- •5.Women of childbearing potential must have a negative serum pregnancy test before randomization.
- •6.Women of childbearing potential must agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months following discontinuation of assigned treatment.
- •7.Signed and dated informed consent prior to transplantation.
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Multiple organ transplants
- •2.Recipients of adult or pediatric en bloc kidney transplants or dual transplantation or non-heart beating donors.
- •3.Evidence of active systemic or localized major infection.
- •4.Evidence of infiltrate, cavitation, or consolidation on chest x-ray obtained during the screening/baseline evaluation.
- •5.Use of any investigational drug or treatment up to 4 weeks prior to transplantation.
- •6.Treatment with voriconazole, ketoconazole, itraconazole, fluconazole, clotrimazole, astemizole, pimozide, terfenadine, erythromycin, clarithromycin, telithromycin, troleandomycin, rifampin, rifabutin, or St. John’s Wort that is not discontinued prior to randomization.
- •7.Treatment with aminoglycosides, amphotericin B, cisplatin, cisapride, metoclopramide, cimetidine, bromocriptine, danazol, or other drugs associated with renal dysfunction that are not discontinued prior to randomization.
- •8.Subjects with a screening/baseline total white blood cell count < 2,000/mm3 or ANC < 500, platelet count < 100,000/mm3.
- •9.Fasting triglycerides > 400 mg/dL (> 4.6 mmol/L) or fasting total cholesterol > 300 mg/dL (> 7.8 mmol/L) despite optimal lipid-lowering therapy.
- •10.History of malignancy within 2 years of enrollment (except for adequately treated basal cell or squamous cell carcinoma of the skin).
- •11.Auto-inmune diseases in active inmunosupressive treatment ( 3 months prior to inclusion).
- •12.Patients with psiquiatric disorders that could be non-compliance for the treatment.
- •13. Active peptic ulcers that could produce intestinal absortion disorders.
- •14. Subjects who are known to be HIV or HBV positive ( surface antigen, HBV DNA, or e antigen positive). Patients with HCV positive should be excluded if PCR positive or transaminates values are =2UNV.
- •15. Diabetic patients.
- •16. Body mass index (BMI) higher than 30 Kg/m2. (See Attachment 5: Nomogram for Determining Body Mass Index).
- •17. Recipients of kidneys from deceased donor after a cardiac arrest.
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