Improvement in Renal Function in Kidney Transplant Recipients Switched from Cyclosporine or Tacrolimus to Belatacept: 2-year Results from the Long-term Extension of a Phase II Study.
Grinyo J, Alberu J, et al.Transplant International, 25(10): 1059-1064, 2012.
Aims
To assess whether improvement in renal function would sustain at two years in kidney transplant recipients who switched from calcineurin inhibitor (CNI) to belatacept.
Interventions
Switch from a CNI-based regimen (cyclosporine or tacrolimus) to belatacept versus continuation on CNI.
Participants
162 renal transplant recipients.
Outcomes
Efficacy outcomes included calculated glomerular filtration rate (GFR) and acute rejection episodes. Safety assessment included serious adverse events, serious infections, malignancies, fungal and virus infections.
Follow-up
2 years
CET Conclusions
In this long term extension of the trial studying the conversion from a calcineurin inhibitor to belatacept the early improvement seen in the calculated GFR was maintained at two years. Although overall there was an improvement in calculated GFR at two years in the belatacept arm compared to patients continued on CNI, this continuing improvement appeared to occur primarily in patients who were converted from tacrolimus rather than cyclosporine where calculated GFR remain roughly stable after 6 months. There were more non serious fungal infections in the belatacept group but no cases of post-transplant lymphoproliferative disorder were reported. It will be interesting to see whether this modest improvement in GFR will increase as time goes by.
Data analysis
Strict intention-to-treat analysis
Quality notes
This paper reported the same trial of the publication: Rostaing L, Massari P, Garcia VD, et al. Switching from calcineurin inhibitor-based regimens to a belatacept-based regimen in renal transplant recipients: a randomized phase II study. Clin J Am Soc Nephrol, 2011; 6: 430. The methodological quality assessment was based on the article by Rostaing et al.
Trial registration
NCT00402168 (ClinicalTrials.gov)