The 3C study (A CAMPATH, Calcineurin inhibitor reduction and Chronic allograft nephropathy trial) aimed to test new ways to improve kidney transplants and make them last for longer.
Kidney transplantation is a very good treatment for people whose kidneys no longer function sufficiently to keep them alive. Unfortunately, kidney transplant function inevitably declines over time. On average, after about 10 years the transplant 'fails' and the recipient either receives another transplant or returns to dialysis.
All people who receive a kidney transplant need drugs to prevent their body from rejecting the new kidney. Unfortunately, standard medications to prevent rejection may also cause long-term damage to the kidney.
The 3C Study tested two treatments at two different stages (at the time of transplant and six months later) post-transplant that might avoid this long-term damage.
The treatments tested at the time of transplant, or 'induction', were alemtuzumab-based versus basiliximab-based therapy. During the long-term, 'maintenance', therapy starting about six months after transplant, the two treatments tested were tacrolimus-based versus sirolimus-based therapy.
A total of 852 participants were randomised to treatment with alemtuzumab-based or basiliximab-based induction treatment. Alemtuzumab-based treatment caused a significant reduction in biopsy-proven acute rejection compared with basiliximab-based treatment in a broad range of patients receiving a kidney transplant. There was no excess of serious or opportunistic infections or other known complications of immunosuppression associated with alemtuzumab.
The second analyses assessed the effects of maintenance therapy with tacrolimus-based versus sirolimus-based therapy on kidney function (estimated glomerular filtration rate [eGFR]) at 18 months after randomisation in 394 participants. At 18 months after conversion to sirolimus‐based maintenance therapy, sirolimus did not improve transplant function and was associated with significant hazards of rejection and infection, compared with tacrolimus.
Long-term follow-up of 3C participants is ongoing.
