Standard Versus Prolonged-release Tacrolimus Monotherapy After Alemtuzumab Induction in Kidney Transplantation
Condition: End-stage Renal Failure; Graft Rejection
MeSH terms: Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      1. 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.

      Patients in the study will be asked to complete a short Health-Related Quality of Life
      questionnaire (SF-36) before transplantation and at 1 year post transplant. They will also be
      asked to complete a Medication Adherence Rating Score at 3, 6, and 12 months post-transplant.
    

Intervention name(s): Tacrolimus (Kidney transplant maintenance immunosuppression); Kidney transplant maintenance immunosuppression
Intervention type(s): Drug; Drug
Intervention description(s): Standard-release Tacrolimus 1 to 20mg daily in two divided doses to maintain trough drug levels 6-9ng/ml; Prolonged-release Tacrolimus 1 to 20mg daily in a single am dose adjusted to trough drug levels 6-9ng/ml
Other intervention name(s): Prograf; Advagraf
Intervention MeSH terms: Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Kidney transplant; Rejection; Adherence; Quality of life