ATG-Fresenius or daclizumab induction therapy in immunologically high risk kidney recipients: a prospective randomized pilot trial
Min Jeong Kim, Dimitrios Tsinalis, Stefan Franz, Isabelle Binet, Lorenz Gürke, Michael J. Mihatsch, Jürg Steiger, Gilbert Thiel, Michael Dickenmann
Ann Transplant 2008; 13(4): 21-27
Background: Despite all the advantages in the immunosuppressive therapy, kidney transplantation in immunologically high risk patients remains a challenge. Ideally, an induction therapy should provide maximal graft protection, while adverse events rate and costs remain as low as possible.
Material & Methods: Immunologically high risk kidney recipients with CDC-PRAÂ»25% within the last 3 years, a positive B-cell CDC-crossmatch or graft loss due to rejection within 3 years following a prior transplantation, were randomized 1:1 to receive ATG-Fresenius (ATG-F) (9 mg/kg day 0; 3 mg/kg day 1-4) or Daclizumab therapy (1 mg/kg day 0, 14, 28, 42, 56) in a pilot study. Additional immunosuppression consisted of cyclosporine, mycophenolate mofetil and steroids. 11 patients were included in each group.
Results: The patient (90% in ATG-F; 100% in Daclizumab) and graft survival (censored for death) (100% in ATG-F; 90% in Daclizumab) and the mean creatinine concentration at 24 months (139±68 Âµmol/l in ATG-F; 176±103 Âµmol/l in Daclizumab) were similar in both groups. More severe graft rejections (3 vascular rejections in Daclizumab) and adverse events (5.3/patient in ATG-F; 6.7/ patient in Daclizumab) were observed in the Daclizumab group. The costs for hospitalization/ day within 24 months were lower in ATG-F (2.32±3.51 USD vs. 12.25±9.75 USD; p=0.02) resulting in an average cost-difference of more than 10'435 USD / patient.
Conclusions: In this pilot trial, both treatments were comparably successful regarding graft and patient outcome.
Keywords: induction therapy