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Standard Versus Prolonged-release Tacrolimus Monotherapy After Alemtuzumab Induction in Kidney Transplantation (TAESR)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Hammersmith Hospitals NHS Trust.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hammersmith Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT00807144
First received: December 10, 2008
Last updated: June 27, 2011
Last verified: June 2011

December 10, 2008
June 27, 2011
December 2008
March 2012   (final data collection date for primary outcome measure)
Patient survival with a functioning graft [ Time Frame: One & two years post kidney transplantation ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00807144 on ClinicalTrials.gov Archive Site
  • Rejection-free patient survival with a functioning graft [ Time Frame: One and two years post kidney transplantation ] [ Designated as safety issue: Yes ]
  • Patient-reported Quality of life, and medication adherence [ Time Frame: 3,6,& 12 months post kidney transplant ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Standard Versus Prolonged-release Tacrolimus Monotherapy After Alemtuzumab Induction in Kidney Transplantation
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

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.

  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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • End-stage Renal Failure
  • Graft Rejection
  • Drug: Tacrolimus (Kidney transplant maintenance immunosuppression)
    Standard-release Tacrolimus 1 to 20mg daily in two divided doses to maintain trough drug levels 6-9ng/ml
    Other Name: Prograf
  • Drug: Kidney transplant maintenance immunosuppression
    Prolonged-release Tacrolimus 1 to 20mg daily in a single am dose adjusted to trough drug levels 6-9ng/ml
    Other Name: Advagraf
  • Experimental: Prolonged-Release Tacrolimus
    Transplant maintenance immunosuppression with Prolonged-release Tacrolimus monotherapy
    Intervention: Drug: Kidney transplant maintenance immunosuppression
  • Active Comparator: Standard-Release tacrolimus
    Transplant maintenance immunosuppression with Standard-release Tacrolimus monotherapy
    Intervention: Drug: Tacrolimus (Kidney transplant maintenance immunosuppression)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
March 2012
March 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact: Adam G McLean, MBBS DPhil 0208 383 1000 ext 5164 adam.mclean@imperial.nhs.uk
Contact: Edmond K Chan, MBBS 0208 383 1000 ext 5164 kk.chan@imperial.ac.uk
United Kingdom
 
NCT00807144
ICKTI08TX02, 2008-000889-22
Yes
Dr Rodney Gale, Imperial College Healthcare NHS Trust
Hammersmith Hospitals NHS Trust
Not Provided
Principal Investigator: Adam G McLean, MA DPhil Imperial College Kidney & Transplant Institute
Hammersmith Hospitals NHS Trust
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP