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Completed

NCT Number: NCT02711202

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

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.

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Key information

Conditions

Kidney Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Alemtuzumab

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.

Other names: Infliximab

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.

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.

Primary outcomes

  1. Number of Patients Alive

    Time frame: 1 year

  2. Number of Patients With Functional Graft

    Time frame: 1 year

Secondary outcomes

  1. Kidney Graft Function (Measured by Serum Creatinine)

    Time frame: 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.

  2. Number of Participants With Biopsy-proven Subclinical Rejection

    Time frame: 1 year

    We calculated the number of participants with biopsy-proven subclinical rejection (based on Banff classification) within 1 year post-transplantation.

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

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Institute for Clinical and Experimental Medicine

Other Gov

Collaborators

  • Charite University, Berlin, Germany
  • Miltenyi Biomedicine GmbH

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Mar 17, 2016
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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