Switching from Calcineurin Inhibitor-based Regimens to a Belatacept-based Regimen in Renal Transplant Recipients: A Randomized Phase II Study.
Rostaing L, Massari P, et al.Clinical Journal of the American Society of Nephrology, 6(2): 430-439, 2011.
Aims
To evaluate the safety and efficacy of switching from a maintenance calcineurin Inhibitor (CNI)-based to a belatacept-based regimen in stable renal transplant patients.
Interventions
Switching to belatacept-based regimen versus remaining on a calcineurin Inhibitor-based regimen (cyclosporine or tacrolimus).
Participants
173 renal transplant patients with stable graft function and receiving a calcineurin inhibitor-based regimen.
Outcomes
The primary endpoint was the change in calculated glomerular filtration rate (GFR) from baseline to month 12. Secondary endpoints included the incidence of acute rejection, renal function, patient and graft survival, new onset diabetes after transplantation, blood pressure and serum lipids. Safety outcomes included (serious) adverse events, malignancies, viral and fungal infections.
Follow-up
12 months
CET Conclusions
In this interesting study patients on a calcineurin inhibitor were randomised to stay on a CNI or be switched to a belatacept based regimen. At month 12, after conversion, there was a modest improvement in the calculated GFR in the belatacept group versus the CNI group. There were some acute rejections, all in the first 6 months after conversion in the belatacept arm. Thus this may represent a feasible method for switching stable renal transplant patients from a CNI regimen to a belatacept based regimen, possibly leading to improved renal function. However a much larger study would be needed to confirm these initial promising results.
Data analysis
Strict intention-to-treat analysis
Trial registration
NCT00402168 (ClinicalTrials.gov).