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Health Condition(s) or Problem
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End-stage Renal Failure; Graft Rejection
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Lay Summary
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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.
(from ClinicalTrials.gov)
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Who can enter the trial
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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
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Who cannot enter the trial
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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
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What will happen
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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; Prograf; 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; Advagraf
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Primary aim
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Patient survival with a functioning graft
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Secondary Aim
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Rejection-free patient survival with a functioning graft; One and two years post kidney transplantation; Yes; Patient-reported Quality of life, and medication adherence; 3,6,& 12 months post kidney transplant; No
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Participant Information Sheet
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Sorry, not currently available
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Website
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Sorry, not currently available
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Recruitment Status
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Recruiting
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Nation
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England
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Location
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London
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