Early calcineurin-inhibitor to belatacept conversion in steroid-free kidney transplant recipients.Tawhari, I., et al.
Frontiers in Immunology 2022; 13: 1096881.
This study aimed to investigate the impact of early tacrolimus to Belatacept (Bela) conversion for maintenance immunosuppressive therapy in kidney transplant recipients.
Participants were randomised to convert to Bela+mycophenolate (MPA), Bela+low dose Tac or to continue with Tac+MPA.
27 kidney transplant recipients.
The primary outcome was the estimated glomerular filtration rate (eGFR). The secondary outcomes were patient survival, graft survival, incidence of de novo donor specific antibodies (DSA), incidence of biopsy proven acute rejection (BPAR), and incidence of adverse events such as posttransplant diabetes mellitus, infections, malignancies, and hyperlipidemia.
This small single-centre study randomised kidney transplant recipients with early steroid withdrawal three months post-transplant to one of three immunosuppressive regimens – Belatacept and MPA, Belatacept and low-dose tacrolimus, or Tacrolimus and MPA. In keeping with previous studies, the acute rejection rate was high in the belatacept/MPA arm, which was discontinued. Outcomes in the other two arms were statistically similar. The study is underpowered, with only 27 patients recruited across the three arms, and so any real conclusions are difficult to make. No sample size calculation is reported, and the original study protocol suggests planned recruitment of 43 patients. Significantly more patients would be required to show a clinically meaningful difference in the primary endpoint of change in eGFR. Of interest, 395 patients were screened for recruitment with only 27 patients consented and enrolled. Inclusion/exclusion criteria were not particularly restrictive, and no explanation is provided as to why recruitment rates were so poor.
Strict intention-to-treat analysis
ClinicalTrials.gov - NCT02213068