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

NCT02711202 | Completed Results

• 1 other identifier: EudraCT Number: 2006-003110-18
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Kidney Transplantation

Outcome Measures

Primary Outcomes (2)

• Number of Patients Alive

  1 year

• Number of Patients With Functional Graft

  1 year

Secondary Outcomes (3)

• Kidney Graft Function (Measured by Serum Creatinine)

  1 year

• Number of Participants With Biopsy-proven Subclinical Rejection

  1 year

• Presence of Subclinical Rejection in Protocol Biopsy at 12 Months (Based on Histological Examination Using Banff Classification)

  1 year

Study Arms (2)

Sirolimus

ACTIVE COMPARATOR

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.

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

Tacrolimus

ACTIVE COMPARATOR

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.

Drug: MabCampath,; Drug: Remicade; Drug: Tacrolimus

Interventions

MabCampath, DRUG

Primary deceased donor kidney transplant recipients received 2x20 mg Alemtuzumab (day 0/day 1) followed by 5 mg/kg Infliximab (day 2). For 14 days all patients received only tacrolimus, then they were randomized to either receive tacrolimus (TAC, n=13) or sirolimus (SIR, n=7) monotherapy, respectively.

Also known as: Alemtuzumab

Sirolimus; Tacrolimus

Remicade DRUG

Primary deceased donor kidney transplant recipients received 2x20 mg Alemtuzumab (day 0/day 1) followed by 5 mg/kg Infliximab (day2). For 14 days all patients received only tacrolimus, then they were randomized to either receive tacrolimus (TAC, n=13) or sirolimus (SIR, n=7) monotherapy, respectively.

Also known as: Infliximab

Sirolimus; Tacrolimus

Sirolimus DRUG

Primary deceased donor kidney transplant recipients received 2x20 mg Alemtuzumab (day 0/day 1) followed by 5 mg/kg Infliximab (day 2). For 14 days all patients received only tacrolimus, then they were randomized to either receive tacrolimus (TAC, n=13) or sirolimus (SIR, n=7) monotherapy, respectively.

Sirolimus

Tacrolimus DRUG

Primary deceased donor kidney transplant recipients received 2x20 mg Alemtuzumab (day 0/day 1) followed by 5 mg/kg Infliximab (day 2). For 14 days all patients received only tacrolimus, then they were randomized to either receive tacrolimus (TAC, n=13) or sirolimus (SIR, n=7) monotherapy, respectively.

Sirolimus; Tacrolimus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: collaborator
• Miltenyi Biomedicine GmbH: collaborator
• Institute for Clinical and Experimental Medicine: lead

Related Publications (1)

• Viklicky O, Hruba P, Tomiuk S, Schmitz S, Gerstmayer B, Sawitzki B, Miqueu P, Mrazova P, Tycova I, Svobodova E, Honsova E, Janssen U, Volk HD, Reinke P. Sequential Targeting of CD52 and TNF Allows Early Minimization Therapy in Kidney Transplantation: From a Biomarker to Targeting in a Proof-Of-Concept Trial. PLoS One. 2017 Jan 13;12(1):e0169624. doi: 10.1371/journal.pone.0169624. eCollection 2017.

  PMID: 28085915 RESULT

Related Links

• Sequential Targeting of CD52 and TNF Allows Early Minimization Therapy in Kidney Transplantation: From a Biomarker to Targeting in a Proof-Of-Concept Trial
• GEO accession for microarray data for peripheral blodd gene expression

MeSH Terms

Interventions

Alemtuzumab; Infliximab; Sirolimus; Tacrolimus

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Macrolides; Lactones; Organic Chemicals

Results Point of Contact

• Title: Prof. Ondřej Viklický, M.D., Ph.D.
• Organization: Institute for Clinical and Experimental Medicine

ondrej.viklicky@ikem.cz

+420 2 6136 4110

Study Officials

• Ondrej Viklicky, M.D.,Prof.

  Institute for Clinical and Experimental Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: IKEM

Study Record Dates

• First Submitted: March 9, 2016
• First Posted: March 17, 2016
• Study Start: January 1, 2007
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: April 13, 2026
• Results First Posted: June 4, 2025

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share