Title: Alemtuzumab (Campath-1H) Induction Followed by Tacrolimus Monotherapy after Combined Kidney-Pancreas Transplanation: Results of a Prospective Randomized Trial
Abstract: Objective of the study: To investigate the safety and efficacy of Campath induction and Tacrolimus (TAC) - maintenance therapy compared to ATG-induction with TAC +MMF + steroids in de novo kidney-pancreas transplanted patients. Methods: 14 patients (group 1) received Campath 30 mg + Methylprednisolone 500 mg before revascularization followed by TAC-monotherapy, and 16 patients (group 2) ATG 8 mg/kg with TAC + MMF+ steroids (withdrawn at month 3). TAC-trough levels (ng/mL) of 12-15 were aimed for in both groups until month 6 and 12 thereafter. Results: 1-year patient survival was 100% in both groups, kidney and pancreas survival in group 1 was 93% each. In group 2 the 1-year kidney/pancreas survival was 100% and 87%. A total of three pancreas grafts were lost due to thrombosis of the graft vein within the first month. The only kidney loss was due to initial non function. All biopsy proven acute rejections of renal transplants (n=3 in group 1, n=0 in group 2) were reversible. No acute pancreas graft rejection was demonstrated. Infectious complications, lipid metabolism and blood pressure were comparable in both groups as were other adverse events (with a tendency towards more vascular complications in group 1 and surgical complications in group 2). No tumor occurred. At 12 months 13 patients each in both groups were steroid-free, the mean serum creatinine level was 1.44 mg/dL in group 1 and 1,33 mg/dL in group 2. All patients were free of exogenous free. Conclusion: At one year efficacy and safety of Campath +TAC-monotherapy was comparable to ATG + TAC + MMF + steroids in combined kidney-pancreas transplant recipients.