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

March 12, 2016 updated by: Petra Hruba, Institute for Clinical and Experimental Medicine

A Pilot, Open Single Centre, Prospective, Parallel Trail to Evaluate the Efficacy and Safety of Immunosuppressive Regimen Without Calcineurin Inhibitors and Steroids After Induction of Anti-CD52 and Anti-TNF-α Monoclonal Antibodies in Kidney Transplant Recipients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Drug: MabCampath,
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.
Other Names:
  • Alemtuzumab
Drug: Remicade
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.
Other Names:
  • Infliximab
Drug: Sirolimus
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.
Drug: Tacrolimus
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.
Active Comparator: 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.
Drug: MabCampath,
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.
Other Names:
  • Alemtuzumab
Drug: Remicade
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.
Other Names:
  • Infliximab
Drug: Tacrolimus
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
number of patients with functional graft
Time Frame: 1 year
1 year
number of patients alive
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
kidney graft function (measured by serum creatinine and glomerular filtration)
Time Frame: 1 year
1 year
the number of bioptically verified rejection episodes and their severity
Time Frame: 1 year
1 year
fibrosis grade and presence of subclinical rejection in protocol biopsy at 12 months
Time Frame: 1 year
1 year
intragraft gene expression (inflammatory cytokines, chemokines and protective factors)
Time Frame: 1 year
1 year
peripheral blood gene expression (inflammatory cytokines, chemokines and protective factors)
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute for Clinical and Experimental Medicine

Collaborators

Charite University, Berlin, Germany
Miltenyi Biomedicine GmbH

Investigators

  • Principal Investigator: Ondrej Viklicky, M.D.,Prof., Institute for Clinical and Experimental Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

March 9, 2016

First Submitted That Met QC Criteria

March 12, 2016

First Posted (Estimate)

March 17, 2016

Study Record Updates

Last Update Posted (Estimate)

March 17, 2016

Last Update Submitted That Met QC Criteria

March 12, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EudraCT Number: 2006-003110-18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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