Tacrolimus and Mycophenolate Mofetil vs Tacrolimus and Sirolimus in SPK, Pancreas After Kidney or Pancreas Transplant Alone
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Event-Specific Survival Comparisons
研究概览
简要总结
This study was designed to determine which maintenance immunosuppressive agent, rapamycin or mycophenalate mofetil, resulted in better outcome in patients with type 1 diabetes and renal failure, who presented for a kidney-pancreas transplant.
详细描述
This is a randomized, prospective single center study evaluating the two maintenance drugs above.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with Type 1 diabetes and end stage renal disease.
- •Women of childbearing potential must have had a negative pregnancy test (serum or urine).
- •Patient agrees to participate in the study and sign an informed consent.
- •Patient has no known contraindication to the administration of rapamycin or mycophenolate mofetil.
- •Patient has no history of hypersensitivity to rapamycin or mycophenolate mofetil.
排除标准
- •Patient has history of a malignancy within two years, with the exception of adequately treated localized squamous or basal cell carcinoma of the skin without evidence of recurrence.
- •Patient is currently abusing drugs or alcohol.
- •Patient is known or suspected to have an active infection or be seropositive for hepatitis B surface antigen (HBsAg), hepatitis C (HCV) or human immunodeficiency virus (HIV).
研究组 & 干预措施
Tacrolimus plus MMF plus Steroids
Patients randomized to this arm were scheduled to receive maintenance therapy consisting of Tacrolimus, Mycophenolate Mofetil (MMF), and Steroids. Patients in both treatment arms received dual induction therapy consisting of Rabbit Anti-thymocyte Globulin (Thymoglobulin) plus Daclizumab.
干预措施: Mycophenolate Mofetil (Drug)
Tacrolimus plus MMF plus Steroids
Patients randomized to this arm were scheduled to receive maintenance therapy consisting of Tacrolimus, Mycophenolate Mofetil (MMF), and Steroids. Patients in both treatment arms received dual induction therapy consisting of Rabbit Anti-thymocyte Globulin (Thymoglobulin) plus Daclizumab.
干预措施: Tacrolimus (Drug)
Tacrolimus plus MMF plus Steroids
Patients randomized to this arm were scheduled to receive maintenance therapy consisting of Tacrolimus, Mycophenolate Mofetil (MMF), and Steroids. Patients in both treatment arms received dual induction therapy consisting of Rabbit Anti-thymocyte Globulin (Thymoglobulin) plus Daclizumab.
干预措施: Steroids (Drug)
Tacrolimus plus Rapamycin plus Steroids
Patients randomized to this arm were scheduled to receive maintenance therapy consisting of Tacrolimus, Rapamycin (Sirolimus), and Steroids. Patients in both treatment arms received dual induction therapy consisting of Rabbit Anti-thymocyte Globulin (Thymoglobulin) plus Daclizumab.
干预措施: Rapamycin (Drug)
Tacrolimus plus Rapamycin plus Steroids
Patients randomized to this arm were scheduled to receive maintenance therapy consisting of Tacrolimus, Rapamycin (Sirolimus), and Steroids. Patients in both treatment arms received dual induction therapy consisting of Rabbit Anti-thymocyte Globulin (Thymoglobulin) plus Daclizumab.
干预措施: Tacrolimus (Drug)
Tacrolimus plus Rapamycin plus Steroids
Patients randomized to this arm were scheduled to receive maintenance therapy consisting of Tacrolimus, Rapamycin (Sirolimus), and Steroids. Patients in both treatment arms received dual induction therapy consisting of Rabbit Anti-thymocyte Globulin (Thymoglobulin) plus Daclizumab.
干预措施: Steroids (Drug)
结局指标
主要结局
Event-Specific Survival Comparisons
时间窗: over 1-10 years post-transplant
Freedom from biopsy-proven acute rejection of the kidney allograft; Freedom from biopsy-proven acute rejection of the pancreas allograft; Death-censored kidney graft survival; Death-censored pancreas graft survival; Death-uncensored graft (kidney and pancreas) survival; and Patient survival.
次要结局
- Overall Kidney Transplant Function at 12, 36, and 60 Months Post-transplant.(at 1-5 years post-transplant)
- Overall Pancreas Transplant Function at 12, 36, and 60 Months Post-transplant.(at 1-5 years post-transplant)
研究者
George W. Burke
Professor of Surgery
University of Miami