N/A N=20 Randomized Screening

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

Kidney Transplantation

Bottom Line

View on ClinicalTrials.gov: NCT02711202 ↗

Enrolled (actual)

Serious AEs

25.0%

Results posted

Jun 2025

Primary outcome: Primary: Number of Patients Alive — 7; 13 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: MabCampath, (Drug); Remicade (Drug); Sirolimus (Drug); Tacrolimus (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Institute for Clinical and Experimental Medicine
Primary completion: Mar 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Patients Alive	7; 13	—
PRIMARY Number of Patients With Functional Graft	6; 13	—
SECONDARY Kidney Graft Function (Measured by Serum Creatinine)	144.4; 110	—
SECONDARY Number of Participants With Biopsy-proven Subclinical Rejection	4; 2	—
SECONDARY Presence of Subclinical Rejection in Protocol Biopsy at 12 Months (Based on Histological Examination Using Banff Classification)	1; 2	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02711202). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.