At a glance
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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
In Brief
A Phase 4 clinical trial evaluating Tacrolimus (Kidney transplant maintenance immunosuppression) and Kidney transplant maintenance immunosuppression for End-stage Renal Failure and Graft Rejection. Completed, enrolled 102 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Standard-release Tacrolimus 1 to 20mg daily in two divided doses to maintain trough drug levels 6-9ng/ml
Prolonged-release Tacrolimus 1 to 20mg daily in a single am dose adjusted to trough drug levels 6-9ng/ml