A Double-Blind, Randomized, Placebo-Controlled Phase Ⅲ Clinical Trial Of Anti-Interleukin-2 Receptor Monoclonal Anti-body(JIANNIPAI) To Prevent Acute Rejection In Early Stage Of Renal Transplantation

OBJECTIVE: To evaluate the efficacy and safety of recombinanthumanized anti-CD25 monoclonal antibody(Jiannipai) produced by ShanghaiGuojian Corporation for prevention of acute rejection in renal allografttransplant recipients within 6 months through a double-blind, randomized,placebo-controlled phaseⅢclinical trial.METHODS: The patients were enrolled and administered eitherJiannipai(1.0mg/kg; or 75mg when body weight is over 75kg) or placeborandomly before transplantation and 14d post-operation. All recipients werefollowed up for 6 months in a double-blind manner. The incidence of acuterejection, the patient's and graft survival rate were observed; the incidence ofside effects including the infection were also recorded.RESULTS: A total of 49 patients were enrolled into the trial and randomizeddivided into study and control groups. 48 patients were administered twodosed injection, with a withdraw rate of 2.1%. Of the 32 patients who received Jiannipai, 3(9.4%) had acute rejection, as compared with 3 of the 16patients(18.8%) who received placebo (p=0.386). Graft survival at 6 monthswas 96.9% in the Jiannipai-treated patients, as compared with 100% in thepatients given placebo(p=1.000). The mean serum creatines(116.5±46.3μmol/L,108.8±46.6μmol/L) of Jiannipai-treated patients at 2ndweek and 3rd week were significantly lower than that(169.3±132.0μmol/L,142.8±74.7μmol/L) of patients given placebo(p=0.047,p=0.049). The meanCcr at 3rd week and 4th weeks in Jiannipai group (71.0±18.5ml/min and70.8±17.2mol/min) were significantly higher than those (56.2±15.7ml/minand 59.4±14.6ml/min) in patients given placebo(p=0.008,p=0.028). 1patient(3.1%) in Jiannipai group had DGF, as compared with 2patients(12.5%) in the controlled group(p=0.254). There were no significantdifferences between the two groups in respect of infectiouscomplication(18.8%vs18.8%, p=1.000). The changes of leukocyte andlymphocyte in Jiannipai group were not significantly different from those inplacebo group. There was only 1 patient who suffered despnea in Jiannipaigroup.CONCLUSION: The recombinant humanized anti-CD25 monoclonalantibody(Jiannipai) produced by shanghai guojian corporation has the trendto prevent the acute rejection and DGF without promoting the risk ofinfection. It can also be helpful for recovering of renal function in earlypost-operation stage with few side effects.