Transplant Trial Watch

Cardiovascular Risk Following Conversion to Belatacept From a Calcineurin Inhibitor in Kidney Transplant Recipients: A Randomized Clinical Trial.

Bredewold, O. W., et al.

Kidney Medicine 2023; 5(1): 100574.

The aim of this study was to compare cardiovascular (CV) risk between belatacept versus calcineurin inhibitor (CNI)–based regimens in kidney transplant recipients (KTRs).

Participants were randomly assigned to either continue with their CNI-based regimen or switch to belatacept for 12 months.

105 kidney transplant recipients aged 18-80 years.

The primary outcome was the estimated CV risk. Secondary outcomes included arterial stiffness, patient survival, graft loss, traditional CVD risk factors in KTRs, acute rejection and CV events.

12 months

CET Conclusions
This multicentre RCT randomised stable kidney transplant recipients to continue their CNI, or to switch to belatacept, for 12 months. Primary outcome was 7-year risk calculation for major cardiac events, using a score validated in kidney transplant recipients. No difference was found in the primary outcome between groups, although blood pressure was improved in the belatacept treated patients. 4 belatacept patients experienced rejection, with one graft loss. Methodology appears reasonable although no method of randomisation is reported and the study is open-label due to the different administration method for the two drugs. ITT analysis is used. The findings are perhaps not too surprising, as most of the components of the risk score (a surrogate for major cardiac events) are unlikely to be modified by a switch to belatacept, particularly given that the majority of participants were already on low-trough tacrolimus dosing. In reality, to see a significant difference in even predicted cardiovascular risk would require a longer treatment duration than the 12 months reported here.

Jadad score

Data analysis
Strict intention-to-treat analysis

Allocation concealment

Trial registration
EudraCT - 2013-001178-20

Funding source
Industry funded