Efficacy and Safety of Two Anti-T-lymphocyte Immune Globulin (ATG-F) Induction Regimens in Anew Kidney Transplant Patients

Study Overview
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Brief Summary
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To investigate the efficacy and safety of ATG-F induction regimen using a single dose of ATG-F compared with a five-day dose regimen of ATG-F in anew kidney transplant recipients.

Detailed Description
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To investigate the efficacy and safety of ATG-F induction regimen using a single dose of ATG-F compared with a five-day dose regimen of ATG-F in de novo kidney transplant recipients. The primary analysis of this study is to demonstrate the non-inferiority of the two regimens with regard to efficacy, defined as failure rate. The secondary objective of the study is the assessment of safety and further efficacy parameters in terms of incidence of acute rejections, graft/patient survival, DGF(delayed graft function) and renal function

Official Title
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Efficacy and Safety of Two Anti-T-lymphocyte Immune Globulin (ATG-F) Induction Regimens in de Novo Kidney Transplant Patients - a Multicenter, Randomized, Parallel Group Study

Conditions
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De Novo Kidney Transplant Patients

Intervention / Treatment
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* Drug: ATG-F


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with end stage kidney disease who is a suitable candidate for primary kidney transplantation. Patients scheduled to undergo renal allograft transplantation with compatible ABO blood type. Peak PRA <50% Females of childbearing potential must have a negative pregnancy test within 48hrs prior to randomization and reliable methods of contraception should be started 4 weeks prior to and during the whole study. Patients capable to understand the purposes and risks of the study, who are willing and able to participate in the study and from whom written and dated informed consent to participate in the study is obtained. Exclusion Criteria: Subject has previously received or is receiving an organ transplant other than kidney Subject is receiving double-kidney transplant. Subject is receiving an ABO incompatible or T-cells cross match positive transplant. Cold ischemia time of allograft is > 24 hours before kidney transplantation surgery. Subject is receiving organ from a Human Leukocyte Antibody (HLA) identical donor. Known contraindication to administration of ATG-F, including: Subject has known hypersensitivity to rabbit proteins Subject with severe thrombocytopenia Subject with bacterial, viral or mycotic infections which are not under therapeutically control Subject has known hypersensitivity to tacrolimus, macrolide antibiotics, mycophenolate mofetil, or any of the product excipients. Subject is unlikely to comply with the visits scheduled in the protocol in the opinion of the investigator or has a history of non-compliance. Pregnant women, nursing mothers, lactating women, and women of child-bearing potential who are unwilling to use reliable contraception during the study and for 6 weeks following completion of the study. Patients with evidence of active liver disease (liver function tests ≥ 2 times upper limit of normal) or the presence of a chronic active hepatitis B or C. Recipient or donor is seropositive for human immunodeficiency virus (HIV).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ATG-F single dosing group<br>Intravenous (IV) | Drug: ATG-F<br>* Intravenous (IV)<br>|
| Experimental: ATG-F continuous dosing group<br>Intravenous (IV) | Drug: ATG-F<br>* Intravenous (IV)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy failure | Efficacy failure is defined as any of the following events: patient's death, graft loss, acute rejection, and/or lost to follow-up. | 12 months post-transplant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of acute rejection |  | 6 and 12 months | 
| Incidence of DGF | DGF = delayed graft function | 6 and 12 months | 
| Incidence of patient survival |  | 6 and 12 months | 
| Incidence of graft survival |  | 6 and 12 months | 
| Renal function: serum creatinine/eGFR |  | 1, 3, 6 and 12 months | 
| incidence and severity of AEs |  | 6 months and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kidney Transplant Patients, ATG-F