Mycophenolic Acid Monotherapy in Recipients of HLA-identical Living-Related Transplantation
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Incidence of Kidney Allograft Rejection and Graft Loss
研究概览
简要总结
This randomized trial will enroll adult recipients of HLA-identical living kidney transplants who are at least 1 year post-transplant. All subjects will be taking Prograf (tacrolimus) or cyclosporine and mycophenolic acid (CellCept or Myfortic) and then be randomized (1:2) to either continue calcineurin inhibitors or to taper off of calcineurin inhibitors. The hypothesis is that mycophenolic acid monotherapy permits long-term rejection-free renal allograft function in the absence of long-term calcineurin inhibitors in this fully matched renal transplant cohort.
详细描述
The objective of the study is to safely move HLA-identical renal transplant recipients from 2 immunosuppressive drugs (calcineurin inhibitor and mycophenolic acid) to mycophenolic acid monotherapy. Safety will be assessed by monitoring renal function in subjects in the withdrawal group compared to those who remain on the standard 2-drug immunosuppression protocol. Results of immunological monitors such as DTH regulation in response to donor minor antigens and development of anti-donor antibodies will be correlated with successful withdrawal.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects 18-75 years of age.
- •Subjects who are recipients of HLA-identical living donor renal allografts from a sibling and are at least 1 year post transplant, their donors and mothers.
- •Subjects must be capable of understanding the purpose and risks of the study and must sign a statement of informed consent.
排除标准
- •GFR <40ml/min;
- •diagnosis of SLE,
- •Subjects with proteinuria (defined as a protein:creatinine ratio of >1 or an amount less than this deemed significant on an individual subject basis by the principal investigator),,
- •multi-organ transplant;
- •known hypersensitivity to, Prograf, Neoral, CellCept or Myfortic;
- •history of documented post transplant non-compliance with medications, transplant clinic or laboratory follow-up;
- •therapy with an investigational immunosuppressive drug within 6 weeks of study entry;
- •history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study;
- •patients on less than 500 mg PO BID of CellCept or 360 mg PO BID of Myfortic at the time of potential randomization,
- •history of humoral rejection post transplant,
- •maintenance or for cause treatment with steroids (prednisone) within 3 months of enrollment.
研究组 & 干预措施
MPA monotherapy
Subjects will discontinue calcineurin inhibitor (cyclosporine or tacrolimus) and remain on MPA (mycophenolate mofetil or mycophenolate sodium) monotherapy
干预措施: Mycophenolic Acid (Drug)
结局指标
主要结局
Incidence of Kidney Allograft Rejection and Graft Loss
时间窗: 36 months
次要结局
- Number of Incidences of Infection and Malignancy(36 months)
- Trans-vivo Delayed Type Hypersensitivity (DTH) Assay(36 months)
- Renal Function Measured by Serum Creatinine and eGFR(36 months)
- Patient Survival(36 months)