Prospective Controlled Protocol for 3 Months Steroid Withdrawal With Tacrolimus, Basiliximab, and Mycophenolate Mofetil in Renal Transplant Recipients
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- the incidence of biopsy-confirmed acute rejection.
研究概览
简要总结
The investigators analyze the clinical outcome of steroid withdrawal protocol starting at 3 months after kidney transplantation using tacrolimus, Mycophenolate Mofetil (MMF), and basiliximab. This study is an open-label, prospective, controlled clinical trial in a single center. Those patients who fulfill the entry criteria could enter in this prospective controlled trial of steroid withdrawal three months after transplantation.
详细描述
Those patients who fulfill the entry criteria enter in this prospective controlled trial of steroid withdrawal starting at three months after transplantation. The entry criteria include 1) no episode of clinically treated nor biopsy confirmed acute rejection up to entry; 2) serum creatinine level equal to or less than 2 mg/mL on three separate measurements; 3) no proteinuria (urine protein less than 1000 mg/24 hours; 4) tacrolimus trough level > 5 ng/ml without signs of nephrotoxicity; 5) agreement to follow the study protocol.
For the patients who enter into the protocol, prednisolone would be slowly withdrawn by 2.5 mg in every two weeks until 8 weeks after entering the protocol (5 months post-transplantation). The patients visit every week, and they are closely monitored with symptoms and signs, blood cell count, chemistry, and urinalysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged more than 13 years who received a primary kidney transplant
- •Subject who is using CNI ± purine synthesis inhibitor + steroid without change within the past 3 months (except the dosage)
- •serum creatinine < 2 mg/dL and the variation of serum creatinine < 30% during the past 3 months
- •Proteinuria ≤ 1g quantified by 24 hour urine or spot urine protein/creatinine ratio < 1.0
- •Subjects who agree with written informed consent
排除标准
- •Subjects who received combined non-renal transplantation.
- •Subject who received re-transplantation
- •Deceased donor without a heartbeat
- •Patients with hypersensitivity to Mycophenolate sodium, Mycophenolate acid or Mycophenolate Mofetil or to any of the excipients.
- •Patient with HGPRT(Hypoxanthin e-guanine phosphoribosyl-transferase) such as Lesch-Nyhan syndrome and kelley-Seegmiller syndrome.
- •HLA-identical living related donor
- •ABO blood group incompatible
- •HIV, HBsAg, or HCV Ab tests (+)
- •Abnormal liver function test (AST or ALT or total bilirubin> upper normal limit x3) ANC < 1,500/μL or WBC < 2,500/μL or platelet < 750,000/μL
- •Women who are either pregnant, lactating, planning to become pregnant in the next 12 months.
- •Subjects with history of cancer, except successfully treated, localized nonmelanocytic skin cancer Subjects with clinically significant infections within the past 3 months.
研究组 & 干预措施
steroid withdrawal
The clinical outcome after kidney transplantation, under the immunosuppression of steroid withdrawal starting at 3 months post-transplantation using tacrolimus, mycophenolate mofetil, and basilixumab should be analyzed.
干预措施: Prednisolone (Drug)
结局指标
主要结局
the incidence of biopsy-confirmed acute rejection.
时间窗: 12 months
The primary efficacy variable was the incidence of biopsy-confirmed acute rejection.
次要结局
- death, graft loss(12 months)
- adverse events and serious adverse events(6 months , 12 months)
研究者
Chang kwon oh
Professor, Department of Surgery
Ajou University School of Medicine