EUCTR2007-000210-36-NL进行中（未招募）不适用
A prospective, randomized, open, multicenter study to evaluate the efficacy and tolerability of induction therapy with a single high-dose anti-T-lymphocyte globulin (ATG-Fresenius) in renal transplant patients with a kidney from a non-heart-beating donor and tacrolimus, mycophenolate mofetil, and steroids as basic immunosuppression. - NHB-ATG
MC St Radboud University Hospital Center0 个研究点开始时间: 2007年8月9日最近更新:
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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. Non-heart-beating-donors (Maastricht III/IV)
- •2. Female patients of childbearing age agree to maintain effective birth control practice during the study.
- •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
- •1. Pregnant or lactating women at the time of randomization.
- •2. Patients and donors are ABO incompatible.
- •3. Women having had >3 pregnancies (including abortions if no consistent data on PRA or anti-donor antibodies are available).
- •4. Patients with hypersensibility to rabbit proteins, previous treatment with rabbit IgG, or known intolerance to any component of basal immunosuppression.
- •5. Patients with leukocytes <3,000/mm3 and/or platelets <50,000/mm3 before initiation of transplant.
- •6. Patients, who are HIV positive.
- •7. Patients subjected to previous transplants or candidates for multiple transplants (e.g. SKP).
- •8. Patients, who are unlikely to comply with the visit schedule in the protocol and patients who cannot communicate reliably with the investigator.
- •9. Patients with pulmonary oedema or with other signs of overhydration.
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