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

This study is currently recruiting participants.
Verified June 2011 by Hammersmith Hospitals NHS Trust
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
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00807144

Contacts
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

Locations
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     adam.mclean@imperial.nhs.uk    
Principal Investigator: Adam G McLean, MA DPhil            
Sponsors and Collaborators
Hammersmith Hospitals NHS Trust
Investigators
Principal Investigator: Adam G McLean, MA DPhil Imperial College Kidney & Transplant Institute
  More Information

No publications provided

Responsible Party: Dr Rodney Gale, Imperial College Healthcare NHS Trust
ClinicalTrials.gov Identifier: NCT00807144     History of Changes
Other Study ID Numbers: ICKTI08TX02, 2008-000889-22
Study First Received: December 10, 2008
Last Updated: June 27, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Tacrolimus
Alemtuzumab
 Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013