Standard Versus Prolonged-release Tacrolimus Monotherapy After Alemtuzumab Induction in Kidney Transplantation (TAESR)
Recruitment status was Recruiting
| Tracking Information | |||||||||
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| First Received Date ICMJE | December 10, 2008 | ||||||||
| Last Updated Date | June 27, 2011 | ||||||||
| Start Date ICMJE | December 2008 | ||||||||
| Estimated Primary Completion Date | March 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Patient survival with a functioning graft [ Time Frame: One & two years post kidney transplantation ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00807144 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Standard Versus Prolonged-release Tacrolimus Monotherapy After Alemtuzumab Induction in Kidney Transplantation | ||||||||
| Official Title ICMJE | 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 | ||||||||
| Brief 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. |
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| Detailed 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 4 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 100 | ||||||||
| Estimated Completion Date | March 2012 | ||||||||
| Estimated Primary Completion Date | March 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 75 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United Kingdom | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00807144 | ||||||||
| Other Study ID Numbers ICMJE | ICKTI08TX02, 2008-000889-22 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Dr Rodney Gale, Imperial College Healthcare NHS Trust | ||||||||
| Study Sponsor ICMJE | Hammersmith Hospitals NHS Trust | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Hammersmith Hospitals NHS Trust | ||||||||
| Verification Date | June 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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