Standard Versus Prolonged-release Tacrolimus Monotherapy After Alemtuzumab Induction in Kidney Transplantation
NCT ID: NCT00807144
Last Updated: 2021-08-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
102 participants
INTERVENTIONAL
2008-12-31
2012-03-31
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Prolonged-Release Tacrolimus
Transplant maintenance immunosuppression with Prolonged-release Tacrolimus monotherapy
Kidney transplant maintenance immunosuppression
Prolonged-release Tacrolimus 1 to 20mg daily in a single am dose adjusted to trough drug levels 6-9ng/ml
Standard-Release tacrolimus
Transplant maintenance immunosuppression with Standard-release Tacrolimus monotherapy
Tacrolimus (Kidney transplant maintenance immunosuppression)
Standard-release Tacrolimus 1 to 20mg daily in two divided doses to maintain trough drug levels 6-9ng/ml
Interventions
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Tacrolimus (Kidney transplant maintenance immunosuppression)
Standard-release Tacrolimus 1 to 20mg daily in two divided doses to maintain trough drug levels 6-9ng/ml
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* heart-beating-Deceased donor kidney transplant recipients
* Patients suitable for induction therapy with Alemtuzumab
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Imperial College Healthcare NHS Trust
OTHER
Responsible Party
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Principal Investigators
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Adam G McLean, MA DPhil
Role: PRINCIPAL_INVESTIGATOR
Imperial College Kidney & Transplant Institute
Locations
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West London Renal & Transplant Centre, Hammersmith Hospital
London, , United Kingdom
Countries
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Related Links
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Other Identifiers
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2008-000889-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ICKTI08TX02
Identifier Type: -
Identifier Source: org_study_id
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