Impact of Cyclosporine or Steroid Withdrawal at 3 Months Post Transplantation on Graft Function, Patient Survival and Cardiovascular Surrogate Markers the First 5 Years After Renal Transplantation.
试验速览
- 阶段
- 4 期
- 入组人数
- 152
- 试验地点
- 5
- 主要终点
- To assess if superior graft function (GFR difference of 10 ml/min) will be achieved at 1 year after transplantation in cohorts of de novo kidney transplant patients treated with Myfortic-everolimus plus steroids compared to Myfortic-cyclosporine.
研究概览
简要总结
This study intends to determine whether steroid withdrawal or calcineurin inhibitor withdrawal is superior for graft function and graft survival. Secondary endpoints for this study are: incidence of tumors and cardiovascular events.
The primary objective: To assess if superior graft function (glomerular filtration rate (GFR) difference of 10 ml/min) will be achieved at 1 year after transplantation in cohorts of de novo kidney transplant patients treated with Myfortic-everolimus plus steroids compared to Myfortic-cyclosporine.
详细描述
Methodology:
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A 5-year, multicentre, prospective, randomized, open-label, controlled study
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Group 1: Simulect + cyclosporine + Myfortic + steroid stop at 3 months
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Group 2: Simulect + cyclosporine (decrease dose in one week at month 3 and replace by everolimus) + Myfortic + steroid maintenance.
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In both groups MPA AUC monitoring will be done at 5-7 days and at 3 months, to ensure sufficient MPA protection.
Sample size calculations:
A total of 152 patients will be randomized (76 patients per group)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female recipients of a de novo kidney transplant, aged above 18 years
- •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
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
研究组 & 干预措施
Cyclosporine
Simulect + cyclosporine + Myfortic + steroid stop at 3 months
干预措施: cyclosporine (Drug)
Everolimus
Simulect + cyclosporine (decrease dose in one week at month 3 and replace by Everolimus (Certican)) + Myfortic + steroid maintenance
干预措施: Everolimus (Drug)
结局指标
主要结局
To assess if superior graft function (GFR difference of 10 ml/min) will be achieved at 1 year after transplantation in cohorts of de novo kidney transplant patients treated with Myfortic-everolimus plus steroids compared to Myfortic-cyclosporine.
时间窗: 1 year
次要结局
- To compare the evolution of graft function (estimated GFR by means of modified MDRD formula)during the first 5 years post transplantation.(5 years)