A Phase-IV Study Comparing Standard Release Tacrolimus (Prograf) vs Prolonged-release Tacrolimus (Advagraf) Monotherapy as Maintenance Immunosuppression After Induction With Alemtuzumab in Kidney Transplantation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Patient Survival With a Functioning Graft
研究概览
简要总结
The current anti-rejection drug regime for kidney transplant recipients in use at the West London Renal & Transplant Centre (WLRaTC) consists of induction therapy with the very potent monoclonal antibody Campath 1-H (Alemtuzumab) followed by long-term maintenance with the Calcineurin inhibitor Tacrolimus
The recent development (and licensing in the UK) of an extended-release, once daily formulation of Tacrolimus holds out the promise of simpler drug regimes for our patients. In the context of our current successful use of Tacrolimus monotherapy maintenance after Campath 1-H induction, the extended-release Tacrolimus formulation will enable us to offer a regime where the only long-term immunosuppressive treatment that most of our patients need will be a single drug, taken once a day.
The investigators wish to assess the efficacy of such a regime in a structured comparison with our current protocol.
详细描述
- Purpose of Study:
The current immunosuppressive regime used as anti-rejection therapy after kidney transplantation in the West London Renal & Transplant Centre at Imperial College Healthcare NHS Trust consists of induction therapy with Campath 1-H(Alemtuzumab) and a 1 week course of steroids followed by maintenance mono-therapy with standard-release (twice daily) Tacrolimus (Prograf). This study is designed to compare the costs and outcomes of this regime with one in which extended-release (once daily) Tacrolimus (Advagraf) is used in place of the standard-release Tacrolimus. 2. Study Type: Phase IV 3. Study Design: Prospective, randomised, controlled, open study. Patients will be randomized 1:1 between the standard and extended-release Tacrolimus arms.
Study entry will be stratified by live donor vs deceased donor transplants. The total recruitment target is 100 patients (50 standard release/50 extended release). 4. Study Description:
Patients will be randomised to receive either Prograf or Advagraf prior to transplantation.
Other than through the taking of extra blood samples at the time of routine clinical visits, participants will receive identical in-patient and out-patient management to patients undergoing kidney transplantation under our standard protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Live donor kidney transplant recipients
- •heart-beating-Deceased donor kidney transplant recipients
- •Patients suitable for induction therapy with Alemtuzumab
排除标准
- •Recipients of Non-heart-beating deceased donor kidney transplants
- •Recipients of simultaneous kidney/pancreas transplants
- •ABO incompatible/desensitized transplant recipients
- •Positive flow cross-match/desensitized transplant recipients
- •Patients with heavy prior exposure to myelosuppressive therapy
- •Patients with previous malignancy
- •Patients with HIV,Hepatitis-C, or Hepatitis-B infection
研究组 & 干预措施
Prolonged-Release Tacrolimus
Transplant maintenance immunosuppression with Prolonged-release Tacrolimus monotherapy
干预措施: Kidney transplant maintenance immunosuppression (Drug)
Standard-Release tacrolimus
Transplant maintenance immunosuppression with Standard-release Tacrolimus monotherapy
干预措施: Tacrolimus (Kidney transplant maintenance immunosuppression) (Drug)
结局指标
主要结局
Patient Survival With a Functioning Graft
时间窗: One year post kidney transplantation
次要结局
- Rejection-free Patient Survival With a Functioning Graft(One and two years post kidney transplantation)
- Patient-reported Quality of Life, and Medication Adherence(3,6,& 12 months post kidney transplant)