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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. The completion date has passed and the status has not been verified in more than two years.
Verified June 2011 by Hammersmith Hospitals NHS Trust.
Recruitment status was:  Recruiting
Information provided by:
Hammersmith Hospitals NHS Trust Identifier:
First received: December 10, 2008
Last updated: June 27, 2011
Last verified: June 2011

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.

Condition Intervention Phase
End-stage Renal Failure
Graft Rejection
Drug: Tacrolimus (Kidney transplant maintenance immunosuppression)
Drug: Kidney transplant maintenance immunosuppression
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official 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

Resource links provided by NLM:

Further study details as provided by Hammersmith Hospitals NHS Trust:

Primary Outcome Measures:
  • Patient survival with a functioning graft [ Time Frame: One & two years post kidney transplantation ]

Secondary Outcome Measures:
  • Rejection-free patient survival with a functioning graft [ Time Frame: One and two years post kidney transplantation ]
  • Patient-reported Quality of life, and medication adherence [ Time Frame: 3,6,& 12 months post kidney transplant ]

Estimated Enrollment: 100
Study Start Date: December 2008
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prolonged-Release Tacrolimus
Transplant maintenance immunosuppression with Prolonged-release Tacrolimus monotherapy
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
Active Comparator: Standard-Release tacrolimus
Transplant maintenance immunosuppression with Standard-release Tacrolimus monotherapy
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

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.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00807144

Contact: Adam G McLean, MBBS DPhil 0208 383 1000 ext 5164
Contact: Edmond K Chan, MBBS 0208 383 1000 ext 5164

United Kingdom
West London Renal & Transplant Centre, Hammersmith Hospital Recruiting
London, United Kingdom, W12 0HS
Contact: Adam G McLean, MA DPhil    020 8383 5164 ext 35164   
Principal Investigator: Adam G McLean, MA DPhil         
Sponsors and Collaborators
Hammersmith Hospitals NHS Trust
Principal Investigator: Adam G McLean, MA DPhil Imperial College Kidney & Transplant Institute
  More Information

Responsible Party: Dr Rodney Gale, Imperial College Healthcare NHS Trust Identifier: NCT00807144     History of Changes
Other Study ID Numbers: ICKTI08TX02
2008-000889-22 ( EudraCT Number )
Study First Received: December 10, 2008
Last Updated: June 27, 2011

Keywords provided by Hammersmith Hospitals NHS Trust:
Kidney transplant
Quality of life

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents processed this record on May 25, 2017