Standard Versus Prolonged-release Tacrolimus Monotherapy After Alemtuzumab ... | Recruiting
Standard Versus Prolonged-release T... | Recruiting
Standard Versus Prolonged-release Tacrolimus Monotherapy After Alemtuzumab Induction in Kidney Transplantation
TAESR
Trial Source

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Medical Conditions
  • End-stage Renal Failure
  • Graft Rejection
Adam G McLean, MBBS DPhil
5164 0208 383 1000
See all trial contact details
Primary Contact Details
Recruiting
Recruitment Status
NCT00807144
Primary Trial ID Number

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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.
Research Details
  • 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.
Phase
Phase 4
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Study Type
Interventional
Intervention
Drug : Tacrolimus (Kidney transplant maintenance immunosuppression), Drug : Kidney transplant maintenance immunosuppression

Study Arm Groups : Standard-Release tacrolimus, Prolonged-Release Tacrolimus

Intervention Type
See Interventions above
Primary Outcome Measures
    Patient survival with a functioning graft; One & two years post kidney transplantation
Secondary Outcome Measures
    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
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
18 Years - 75 Years
Who Can Participate
Patients
Number of Participants
100
Participant Inclusion Criteria
    Inclusion Criteria:

    - Live donor kidney transplant recipients

    - heart-beating-Deceased donor kidney transplant recipients

    - Patients suitable for induction therapy with Alemtuzumab

    Exclusion Criteria:

    - 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
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
London
W12 0HS
Trial Contact(s)
Primary Trial Contact
Adam G McLean, MBBS DPhil
5164 0208 383 1000
Other Trial Contacts
Edmond K Chan, MBBS
5164 0208 383 1000
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
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
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
ICKTI08TX02
Sponsor(s)
Hammersmith Hospitals NHS Trust
Key Dates

Recruitment Start Date

Dec 2008

Recruitment End Date

Mar 2012

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

10 Dec 2008

Date updated in source

27 Jun 2011