Randomized, prospective trial of mycophenolate mofetil versus azathioprinefor prevention of acute renal allograft rejection after simultaneous kidney-pancreas transplantation

Background. In simultaneous kidney-pancreas (SPK) transplantation, manifest ations of renal allograft rejection typically become evident before those o f pancreatic rejection. This study compared mycophenolate mofetil (MMF) and azathioprine (AZA) in prevention of renal rejection after primary SPK tran splantation. Methods. In an open-label, randomized, multicenter study, patients received MMF 1.5 g twice daily (n=74) or AZA 1-3 mg/kg daily (n=76) for 1 year afte r transplantation, The incidence of rejection was assessed at 6 months. Adv erse events were tracked through 1 year. Survival data are reported through 2 years. Results. At 6 months, efficacy results for MMF vs. AZA patients, respective ly, were the following: rejection (27% vs. 39%); rejection or death (34% vs . 42%); rejection, graft loss, death, or premature withdrawal (i.e., treatm ent failure; 41% vs. 55%). Six-month efficacy trends favored MMF, and time to rejection or treatment failure was significantly longer when compared wi th AZA (P=0.049). One-year efficacy results for MMF vs. AZA patients, respe ctively, were the following: treatment of renal rejection (35% vs. 47%); re nal allograft loss or death (9% vs. 12%); pancreas allograft loss or death (15% vs, 14%). Five MMF patients (7%) and four (5%) in the AZA group died. More MMF than AZA patients developed opportunistic infections (54% vs. 38%) , but the pathogens did not differ. Conclusions. Trends for most efficacy parameters favored MMF over AZA, and time to renal allograft rejection or treatment failure was statistically si gnificantly longer for MMF. The use of MMF in the treatment of SPK recipien ts is a useful advance.