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

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute for Clinical and Experimental Medicine
• Collaborators: Charite University, Berlin, Germany; Miltenyi Biomedicine GmbH; Miltenyi Biotec GmbH
• Treatments: Alemtuzumab; Antibodies; Antibodies, Monoclonal; Calcineurin Inhibitors; Everolimus; Infliximab; Sirolimus; Tacrolimus

Criteria

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