A randomized and prospective study comparing treatment with high-dose intravenous immunoglobulin with monoclonal antibodies for rescue of kidney grafts with steroid-resistant rejection

Background. The aim of this study was to compare the effectiveness of intra venous immunoglobulin (Mg) versus monoclonal anti-CD3 as a treatment for st eroid-resistant rejections, From January 1995 to June 1997, 30 patients wer e analyzed. They were randomized into two groups. Resistant rejections were diagnosed by core biopsy. Group A received 500 mg/kg/day Mg (Sandoglobulin ) for 7 consecutive days, whereas group B received 5 mg/day of OKT3 for 14 consecutive days. Daily T cell CD3(+) peripheral count was performed for 14 days for group B, The immunosuppression was similar for both groups. Cyclo sporine was stopped during both treatments. Methods. Demographic factors, HLA mismatch, creatinine levels before and af ter treatment, and the incidence of rejections after treatment (up to 1 mon th) were taken into account for this study, Results. Data from different samples were compared using Fisher's exact tes t. Graft and patient survival were analyzed using the Kaplan-Meier method. The were no significant differences found in age, graft origin, HLA mismatc h, or time of follow-up until the episode of rejection. Success was achieve d for 11 (73.3%) of 15 of group A and 13 (86.6%) of 15 of group B (P=0.79). Creatinine levels before and after treatment were as follows: A, 2.99+/-1. 30 mg/dl and 2.1+/-0.70 mg/dl versus B, 3.1+/-1.1 mg/dl and 2.5+/-0.8 mg/dl . Besides, we did not observe differences in the creatinine 1 month after t reatment (A: 2.35+/-0.78 mg/dl; B: 2.51+/-1.10 mg/dl; P=0.66) nor in the th ird month (A: 1.83+/-0.58 mg/dl; B: 2.30+/-0.89 mg/dl; P=0.24), The inciden ce of rejections after treatment was 5 (46%) of 11 for group A and 9 (75%) of 12 for group B (P=0.4), The patient survival rates 2 years after treatme nt were 87 and 92% for A and B groups, respectively, Graft survival was ide ntical (80% in both groups). Conclusion. Should the favorable result presented in this report be confirm ed in larger number of patients, Mg could become the preferable choice of r ejection treatment for steroid-resistant rejection because of a complete ab sence of the unwanted side effects commonly associated with OKT3.