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

Kidney Transplantation Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02711202
• Other study ID #: EudraCT Number: 2006-003110-18
• Status: Completed
• Phase: N/A
• First received: March 9, 2016
• Last updated: March 12, 2016
• Start date: January 2007
• Est. completion date: March 2009

Study information

• Verified date: March 2016
• Source: Institute for Clinical and Experimental Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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-a

• 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Institute for Clinical and Experimental Medicine	Charite University, Berlin, Germany, Miltenyi Biotec GmbH

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of patients with functional graft		1 year	Yes
Primary	number of patients alive		1 year	Yes
Secondary	kidney graft function (measured by serum creatinine and glomerular filtration)		1 year	Yes
Secondary	the number of bioptically verified rejection episodes and their severity		1 year	Yes
Secondary	fibrosis grade and presence of subclinical rejection in protocol biopsy at 12 months		1 year	Yes
Secondary	intragraft gene expression (inflammatory cytokines, chemokines and protective factors)		1 year	No
Secondary	peripheral blood gene expression (inflammatory cytokines, chemokines and protective factors)		1 year	No