Enteric-coated mycophenolate sodium given in combination with tacrolimus has a lower incidence of serious infections in Asian renal-transplant recipients compared with mycophenolate mofetil.
Feng JJ, Zhang LW, et al.International Journal of Clinical Practice 2015; Supplement (183): 1-7.
Aims
To compare the effect of mycophenolate sodium (EC-MPS) with mycophenolate mofetil (MMF) when administered in combination with tacrolimus in Asian renal-transplant recipients
Interventions
Patients were randomized to receive either EC-MPS or MMF.
Participants
101 live-donor kidney transplant recipients aged 18–65 years
Outcomes
The primary outcomse measured were the incidences of infection and serious infections. Gastro-intestinal adverse events (GI AEs), diarrhoea, serum creatinine and biopsy proven acute rejection (BPAR) were also measured.
Follow-up
24 months
CET Conclusions
This open-label RCT of 101 patients compared infection rates in new recipients of first living donor kidney transplants. Patients received triple immune suppression, which included ATG induction, tacrolimus and either Mycophenolate Mofetil (750mg) or Enteric-coated Mycophenolate Sodium (540mg). Similar AUC drug profiles were seen comparing the two drugs. The incidence of infections overall was the same between the two groups, however there was a higher incidence of severe infections in the MMF group. Serious infections were defined but were not described for each patient that experienced this event. The incidence of biopsy proven acute rejection was the same between the two groups. No power calculation was reported.
Data analysis
Per protocol analysis
Trial registration
Chinese Clinical Trials Register - ChiCTR-IPR-14005509