Standard Versus Prolonged-release Tacrolimus Monotherapy After Alemtuzumab Induction in Kidney Transplantation

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.

Timeline

Start

2008-12

Primary completion

2012-03

Completion

2012-03

Outcome

Missed primary endpoint

registry analysis (superiority test); Extended Release Tacrolimus vs Standard Release Tacrolimus; p = 0.26; Log Rank NCT00807144 ↗

Drugs

Indications