Standard Versus Prolonged-release Tacrolimus Monotherapy After Alemtuzumab Induction in Kidney Transplantation (TAESR)
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|ClinicalTrials.gov Identifier: NCT00807144|
Recruitment Status : Unknown
Verified June 2011 by Hammersmith Hospitals NHS Trust.
Recruitment status was: Recruiting
First Posted : December 11, 2008
Last Update Posted : June 28, 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 or disease||Intervention/treatment||Phase|
|End-stage Renal Failure Graft Rejection||Drug: Tacrolimus (Kidney transplant maintenance immunosuppression) Drug: Kidney transplant maintenance immunosuppression||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||December 2008|
|Estimated Primary Completion Date :||March 2012|
|Estimated Study Completion Date :||March 2012|
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
- Patient survival with a functioning graft [ Time Frame: One & two years post kidney transplantation ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00807144
|Contact: Adam G McLean, MBBS DPhil||0208 383 1000 ext email@example.com|
|Contact: Edmond K Chan, MBBS||0208 383 1000 ext firstname.lastname@example.org|
|West London Renal & Transplant Centre, Hammersmith Hospital||Recruiting|
|London, United Kingdom, W12 0HS|
|Contact: Adam G McLean, MA DPhil 020 8383 5164 ext 35164 email@example.com|
|Principal Investigator: Adam G McLean, MA DPhil|
|Principal Investigator:||Adam G McLean, MA DPhil||Imperial College Kidney & Transplant Institute|