Transplant Trial Watch

A pilot randomized controlled trial of de novo belatacept-based immunosuppression following anti-thymocyte globulin induction in lung transplantation.

Huang, H. J., et al.

American Journal of Transplantation 2022 [record in progress].


Aims
This pilot randomised controlled trial (RCT) aimed to examine the efficacy and safety of belatacept-based immunosuppression following lung transplantation.

Interventions
Patients were randomised into two arms: the belatacept- based immunosuppression arm, in which patients received tacrolimus, belatacept, and prednisone until day 89 followed by belatacept, mycophenolate mofetil (MMF), and prednisone; or the control arm, where patients received tacrolimus, MMF and prednisone.

Participants
27 lung transplant recipients.

Outcomes
The primary outcome was the feasibility metric of randomising 80% of eligible patients within 4 hours posttransplantation.

Follow-up
365 days

CET Conclusions
This pilot RCT investigated the use of belatacept-based immunosuppression in lung transplant recipients. Standard immunosuppression with Tac/MMF/Pred was compared to belatacept and prednisolone-based immunosuppression in conjunction with tacrolimus for the first 3 months and MMF thereafter. Recruitment was stopped after 3 deaths in the belatacept arm – a further two patients subsequently died. The authors conclude that belatacept-based immunosuppression in lung transplant recipients is associated with excess mortality. The results in such a small number of patients are difficult to interpret – causes of death were different for all 5 recipients (PE, haemothorax, restrictive allograft syndrome, COVID-19 and PTLD). Three deaths related to possible viral infection, which may reflect the overall immunosuppressive burden of the regimen. Given the excess mortality, the DSMB were correct to stop the trial despite the small sample size.

Jadad score
2

Data analysis
Per protocol analysis

Allocation concealment
No

Trial registration
ClinicalTrials.gov - NCT03388008

Funding source
Industry & non-industry funded