Open-label, Randomised Multicentre Study of CAMPATH-1H Versus Basiliximab Induction Treatment and Sirolimus Versus Tacrolimus Maintenance Treatment for the Preservation of Renal Function in Patients Receiving Kidney Transplants
The long-term survival of kidney transplants has not improved over the past decade despite
reductions in the rate of acute rejection. The commonest cause of late graft loss is chronic
allograft nephropathy which is frequently caused by calcineurin inhibitor toxicity.
Therefore, it may be possible to improve long-term graft outcomes by reducing the amount of
calcineurin inhibitor exposure.
Two possible strategies to do this will be tested. Firstly, Campath-1H (a monoclonal
lymphocyte-depleting antibody) will be compared to standard basiliximab-based induction. All
patients will then receive tacrolimus-based maintenance therapy for 6 months (using lower
doses in the Campath-1H arm).
At six months, patients will be re-randomised between remaining on tacrolimus and converting
to sirolimus (and therefore no longer take calcineurin inhibitors). Patients will then be
followed-up in clinic and through routine NHS registries to collect information on relevant
outcomes (including graft function, survival, hospitalisations and death).
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Biopsy-proven acute rejection
Primary outcome for induction therapy comparison
University of Oxford
United Kingdom: Medicines and Healthcare Products Regulatory Agency