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

Not Applicable

Completed

• Conditions: Kidney Transplantation
• Interventions: Drug: MabCampath,; Drug: Remicade; Drug: Sirolimus; Drug: Tacrolimus

• Registration Number: NCT02711202
• Lead Sponsor: Institute for Clinical and Experimental Medicine

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Study First Submitted: 2016-03-09
• Study First Submitted QC: 2016-03-12
• Study First Posted: 2016-03-17
• Results First Submitted: 2025-04-29
• Status Verified: 2025-06
• Results First Submitted QC: 2025-06-02
• Last Update Submitted: 2025-06-02
• Results First Posted: 2025-06-04
• Last Update Posted: 2025-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sirolimus	MabCampath,	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.
Sirolimus	Remicade	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.
Sirolimus	Tacrolimus	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.
Tacrolimus	MabCampath,	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.
Tacrolimus	Remicade	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.
Tacrolimus	Tacrolimus	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.
Sirolimus	Sirolimus	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.

Primary Outcome Measures

Name	Time	Method
Number of Patients Alive	1 year
Number of Patients With Functional Graft	1 year

Secondary Outcome Measures

Name	Time	Method
Kidney Graft Function (Measured by Serum Creatinine)	1 year	Kidney graft function is measured as serum creatinine in umol/l at 1 year after transplantation. Higher levels of creatinine represents worse graft function.
Number of Bioptically Verified Rejection Episodes	1 year	We calculated the number of participants with biopsy-proven subclinical rejection (based on Banff classification) within 1 year post-transplantation.
Presence of Subclinical Rejection in Protocol Biopsy at 12 Months (Based on Histological Examination Using Banff Classification)	1 year