A Randomized, Double-blind, Placebo-Controlled Study of Single Dose Rituximab as Induction in Renal Transplantation: a 3-year Follow-up.
Tyden G, Ekberg H, et al.Transplantation 2012; 94(3): e21-e22.
Aims
To assess 3-year post-transplant outcomes in renal transplant recipients who received a single dose rituximab as induction therapy.
Interventions
Infusion of one dose of rituximab 375 mg/m2 body surface area in 500 ml 5% glucose versus infusion 500 ml 5% glucose only (placebo). All patients received immunosuppressive therapy consisting of tacrolimus, mycophenolate mofetil and steroids. All patients were given antiviral prophylaxis with valganciclovir if cytomegalovirus incompatible otherwise with valaciclovir and bactrim as pneumocystis jirocvecii prophylaxis.
Participants
136 renal transplant recipients.
Outcomes
Rejection episodes, graft loss, death, causes of mortality, development of donor-specific antibodies, bacterial infections, fungal infections, cytomegalovirus infections and polyomavirus infections.
Follow-up
3 years
CET Conclusions
Three-year follow up of a randomised and double blind trial of rituximab induction therapy for ABO-compatible renal transplantation is presented. There were a high number of dropouts and only 67% of the randomised patients could be analysed at this length of follow up, although dropouts were evenly spread between the two arms. Rituximab was associated with a significantly increased mortality rate (largely due to cardiovascular mortality). There was no difference in the development of donor-specific antibodies or graft loss.
Data analysis
Per protocol analysis
Quality notes
The quality assessment is based on a previous report of the same trial: “Tyden G, Genberg H, et al. A Randomized, Double-blind, Placebo-Controlled, Study of Single-Dose Rituximab as Induction in Renal Transplantation. Transplantation, 87(9): 1325-1329, 2009.
Trial registration
Not reported