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
Overview
- Phase
- Not Applicable
- Intervention
- Sirolimus
- Conditions
- Kidney Transplantation
- Sponsor
- Institute for Clinical and Experimental Medicine
- Enrollment
- 20
- Primary Endpoint
- Number of Patients Alive
- Status
- Completed
- Last Updated
- 19 days ago
Overview
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.
Investigators
Petra Hruba
IKEM
Institute for Clinical and Experimental Medicine
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
Arms & Interventions
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.
Intervention: Sirolimus
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.
Intervention: Tacrolimus
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.
Intervention: MabCampath,
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.
Intervention: MabCampath,
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.
Intervention: Remicade
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.
Intervention: Remicade
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.
Intervention: Tacrolimus
Outcomes
Primary Outcomes
Number of Patients Alive
Time Frame: 1 year
Number of Patients With Functional Graft
Time Frame: 1 year
Secondary Outcomes
- Number of Participants With Biopsy-proven Subclinical Rejection(1 year)
- Kidney Graft Function (Measured by Serum Creatinine)(1 year)
- Number of Bioptically Verified Rejection Episodes(1 year)
- Presence of Subclinical Rejection in Protocol Biopsy at 12 Months (Based on Histological Examination Using Banff Classification)(1 year)