Benefits of rituximab combined with intravenous immunoglobulin for desensitization in kidney transplant recipients.
Vo AA, Choi J, Cisneros K, et al.Transplantation 2014; 98(3): 312-319
Aims
To investigate the efficacy of rituximab as a desensitisation agent in deceased donor kidney transplant recipients.
Interventions
Patients were administered with human polyclonal intravenous immunoglobin (IVIG) plus placebo (on days 1 and 30) or IVIG (on days 1 and 30) plus rituximab on day 15. Transplant patients received an additional dose of IVIG at transplantation (within 10 days) and an additional dose of rituximab (1g) or placebo at 6 months post-transplant.
Participants
15 highly HLA-sensitised patients awaiting transplantation.
Outcomes
The primary end point was the rate of transplantation between the two groups.
Follow-up
1 year.
CET Conclusions
This trial investigated the use of rituximab as part of a desensitisation protocol for highly sensitised transplant recipients on the deceased donor waiting list. Recipients were randomised to receive high dose IvIG and either rituximab or placebo at a 1 month interval, and then if DSA levels and crossmatch were acceptable allowed to proceed to deceased donor transplant. The study originally set out to randomise 90 patients, but recruitment was halted after 13 transplants due to concerns regarding high levels of antibody mediated rejection (ABMR) and graft loss. All ABMR and graft losses were seen in the placebo group, suggesting that high-dose IvIG alone may not be suitable for desensitisation in this setting. However, the numbers are small meaning that the differences between groups do not reach statistical significance.
Data analysis
Available case analysis
Trial registration
NCT01178216