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

Institute for Clinical and Experimental Medicine

Status: Completed

Conditions: Kidney Transplantation

Treatments: Drug: Sirolimus; Drug: MabCampath,; Drug: Remicade; Drug: Tacrolimus

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02711202

EudraCT Number: 2006-003110-18

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Sirolimus

Active Comparator group

Description:

Patients received two applications of anti-CD52 MabCampath (Alemtuzumab), a single dose of anti-TNF-α Remicade (Infliximab) monoclonal antibodies in the early posttransplant period. First 14 days patients received tacrolimus monotherapy, at post-operative day (POD) 14, they were randomized to sirolimus monotherapy.

Treatment:

Drug: Tacrolimus

Drug: Remicade

Drug: MabCampath,

Drug: Sirolimus

Tacrolimus

Active Comparator group

Description:

Patients received two applications of anti-CD52 MabCampath (Alemtuzumab), a single dose of anti-TNF-α Remicade (Infliximab) monoclonal antibodies in the early posttransplant period. First 14 days patients received tacrolimus monotherapy, at POD 14, they were randomized to tacrolimus monotherapy.

Treatment:

Drug: Tacrolimus

Drug: Remicade

Drug: MabCampath,