An Open-Label, Comparative Trial of Two Daclizumab Dosing Strategies Versus No Induction Treatment in Combination With Tacrolimus, Mycophenolate Mofetil, and Steroids for the Prevention of Acute Allograft Rejection in Simultaneous Kidney/Pancreas Transplant Recipients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 298
- 试验地点
- 24
- 主要终点
- To assess the incidence of presumed acute kidney or pancreas rejection, death, and kidney or pancreas graft loss in the first 6 months post transplant.
研究概览
简要总结
The purpose of the study is to determine the safety and efficacy of two dosing regimens of daclizumab in simultaneous kidney/pancreas transplant recipients.
详细描述
The purpose of the study is to determine the safety and efficacy of two dosing regimens of daclizumab as an adjunctive immunosuppressive agent in simultaneous kidney/pancreas transplant recipients receiving tacrolimus, mycophenolate mofetil, and steroids as primary maintenance immunosuppression.
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
- •Simultaneous kidney/pancreas transplant recipients
- •Insulin dependent Type 1 or 2 diabetes pretransplant
- •Recipient age 18-65 years
- •Donor age 5-65 years
- •Women must have negative serum pregnancy test and practice birth control for study duration
- •Negative T-cell crossmatch
- •Parent (or guardian) is able to understand the consent form and give written informed consent
排除标准
- •Prior treatment with daclizumab
- •Known sensitivity or contraindication to tacrolimus, MMF, or steroids
- •Patient with significant or active infection
- •Patients with a positive lymphocytotoxic crossmatch using donor lymphocytes and recipient serum
- •Patients whose life expectancy is severely limited by diseases other than renal disease
- •Ongoing substance abuse, drug or alcohol
- •Major ongoing psychiatric illness or recent history of noncompliance
- •Insufficient cardiovascular reserve
- •Malignancy within last 5 years, excluding nonmelanoma skin cancers
- •Serologic evidence of infection with HIV or Hepatitis B surface antigen positive
- •Investigational drug within 30 days prior to transplant surgery
- •Anti-T cell therapy within 30 days prior to transplant surgery
研究组 & 干预措施
5 Dose Daclizbumab
daclizumab 1 mg/kg/dose every 14 days for 5 doses
干预措施: Daclizumab (Drug)
2 Dose Daclizaumab
daclizumab 2 mg/kg/dose every 14 days for 2 doses
干预措施: Daclizumab (Drug)
Control
no antibody induction
干预措施: Daclizumab (Drug)
结局指标
主要结局
To assess the incidence of presumed acute kidney or pancreas rejection, death, and kidney or pancreas graft loss in the first 6 months post transplant.
次要结局
- Hospitalizations.
- Incidence, timing and severity of fungal infections.
- Incidence, timing and severity of malignancies.
研究者
Rita Alloway
Investigator
University of Cincinnati