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NCT Number: NCT00807144

Standard Versus Prolonged-release Tacrolimus Monotherapy After Alemtuzumab Induction 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.

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Key information

Conditions

End-stage Renal Failure Behavior Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Graft Rejection Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Rejection, Psychology Renal Insufficiency Renal Insufficiency, Chronic Social Behavior Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

West London Renal & Transplant Centre, Hammersmith Hospital

London, W12 0HS, United Kingdom

About this study

  • 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.

  • Study Type: Phase IV
  • 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).

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tacrolimus (Kidney transplant maintenance immunosuppression)

Drug

Standard-release Tacrolimus 1 to 20mg daily in two divided doses to maintain trough drug levels 6-9ng/ml

Other names: Prograf

Kidney transplant maintenance immunosuppression

Drug

Prolonged-release Tacrolimus 1 to 20mg daily in a single am dose adjusted to trough drug levels 6-9ng/ml

Other names: Advagraf

Primary outcomes

  1. Patient Survival With a Functioning Graft

    Time frame: One year post kidney transplantation

Secondary outcomes

  1. Rejection-free Patient Survival With a Functioning Graft

    Time frame: One and two years post kidney transplantation

  2. Patient-reported Quality of Life, and Medication Adherence

    Time frame: 3,6,& 12 months post kidney transplant

Sponsors and collaborators

Lead sponsor

Imperial College Healthcare NHS Trust

Other

Registry information

Official study 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

Acronym: TAESR

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Dec 11, 2008
Registry last updated
Aug 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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