EUCTR2007-005844-26-BE进行中（未招募）1 期
Multicentre, prospective, randomized, open-label, controlled study in de novo kidney transplant recipients to evaluate the impact of cyclosporine or steroid withdrawal at 3 months on graft function, patient and graft survival, and cardiovascular surrogate markers during the first five years after transplantation. - Cistcert
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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 recipients of a de novo kidney transplant, aged above 18 yrs.
- •?Women of childbearing potential must have a negative serum or urine pregnancy test with sensitivity equal to at least 50 mIU/ml.
- •?Patients must be capable of understanding the purpose and risks of the study, and must sign an informed consent form
- •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
- •?Multiple organ transplantation (e.g. Kidney-pancreas, kidney-heart, kidney-liver,…)
- •?Transplantation of a patient who got another organ transplant previously
- •?Recipients of a HLA-identical living-related renal transplant
- •?Patients with PRA > 30%, patients who have lost a first graft from rejection within two years after transplantation, and African European patients.
- •?Patients with primary renal disease at risk for recurrence: FSGS, MPGN, HUS
- •?Pregnant or lactating women
- •?WBC < 2.5 x 109/l (IU), platelet count < 100 x 109/l (IU), or Hb < 6 g/dl at the time of entry into the study
- •?Active peptic ulcer
- •?Severe diarrhea or other gastrointestinal disorder, which might interfere with their ability to absorb oral medication, including diabetic patients with previously diagnosed diabetic gastroenteropathy
- •?Known HIV-1 or HTLV-1 positive tests
- •?The use of investigational drugs or other immunosuppressive drugs, as those specified in this protocol
- •?Patients receiving bile acid sequestrants
- •?Psychological illness or condition, interfering with the patient’s compliance or ability to understand the requirements of the study.
研究者
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