Sequential Targeting of Cluster of Differentiation 52 (CD52) and Tumor Necrosis Factor (TNF) Allows Early Minimization Therapy in Kidney Transplantation

A Pilot, Open Single Centre, Prospective, Parallel Trail to Evaluate the Efficacy and Safety of Immunosuppressive Regimen Without Calcineurin Inhibitors and Steroids After Induction of Anti-CD52 and Anti-TNF-α Monoclonal Antibodies in Kidney Transplant Recipients

The aim of the study is to evaluate the efficacy of new immunosuppressive protocol based on two applications of anti-CD52 MabCampath (Alemtuzumab) a single dose of anti-TNF-α Remicade (infliximab) monoclonal antibodies in the early posttransplant period followed by either monotherapy based on tacrolimus or sirolimus.

Inclusion criteria:

• First deceased-donor kidney transplantation
• Age >18 years
• Donor <65 years
• Cytomegalovirus (CMV)/ Epstein-Barr virus (EBV) seropositivity
• panel reactive antibodies (PRA) <10%
• Written consent

Exclusion criteria:

• Retransplantation, combined transplantation
• Prior immunosuppression less than 6 months prior transplantation
• Induction therapy with antibodies
• Leukopenia < 4000, thrombocytopenia < 100 000, Haemoglobin < 80 g/l
• History of antithymoglobulin (ATG) or anti-cluster of differentiation 3 (CD3) monoclonals or anti-TNF-α
• Tuberculosis history
• Anti-hepatitis C virus (HCV) positivity, HBsAg
• HIV positivity
• Malignancy history
• Allergy to study medication
• Fertile women without contraception
• Pregnancy, breastfeeding mothers