Standard Versus Prolonged-release Tacrolimus Monotherapy After Alemtuzumab Induction in Kidney Transplantation | Recruiting
Standard Versus Prolonged-release Tacrolimus Monotherapy After Alemtuzumab Induction in Kidney Transplantation
TAESR
Trial Source

Health Conditions
  • End-stage Renal Failure
  • Graft Rejection
Recruiting
Recruitment Status
NCT00807144
Primary Trial ID Number
Summary
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.
Primary Outcome Measures
  • Patient survival with a functioning graft; One & two years post kidney transplantation
Secondary Outcome Measures
  • Rejection-free patient survival with a functioning graft; One and two years post kidney transplantation; Patient-reported Quality of life, and medication adherence; 3,6,& 12 months post kidney transplant
Research Question
  • 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.
Design Type
Sorry, this information is not available
Ethics Approval
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Publications
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Countries of Recruitment
United Kingdom
Participant Sex
Both
Participant Age Range
18 Years to 75 Years
Participant Type
Sorry, this information is not available
Trial Sample Size
100
Participant Inclusion 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
Participant Exclusion 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
Interventions
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; [Standard-Release tacrolimus]; 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; [Prolonged-Release Tacrolimus]
Design Details
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Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Results Reporting
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Acronym
TAESR
Scientific 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
Secondary Trial Identifying Number
2008-000889-22
Website
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Study Funded By
Hammersmith Hospitals NHS Trust
Funder Type
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Study Sponsored By
Hammersmith Hospitals NHS Trust
Study Also Sponsored By
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Primary Sponsor Type
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Secondary Sponsor Type
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Key Dates

Date of First Enrollment
Date Not Available
Recruitment End Date
Date Not Available
Trial End Date
Date Not Available
Date added to Registry

10 Dec 2008

Last Updated

27 Jun 2011

Date Record Refreshed on UKCTG

31 Jul 2015