A prospective, randomized, open, multicenter study to evaluate the efficacy and tolerability of induction therapy with a single high-dose anti-T-lymphocyte globulin (ATG-Fresenius) in renal transplant patients with a kidney from a non-heart-beating donor and tacrolimus, mycophenolate mofetil, and steroids as basic immunosuppression.

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2007
INTERVENTION: Trade Name: ATG‐Fresenius Pharmaceutical Form: Solution for infusion CONDITION: Transplantation of a renal graft from a non‐heart‐beating donor PRIMARY OUTCOME: Main Objective: Main objective of this study is to compare the efficacy and tolerability of polyclonal antibody as induction therapy vs. no antibody induction, with special regard to the incidence of initial delayed graft function.; ; Primary end point(s): Incidence of initial DGF (defined as the need for dialysis after transplantation). Secondary Objective: The main secondary objectives of the trial are:; ‐ the duration of initial DGF ; ‐ Incidence of primary non‐functioning grafts.; ‐ Acute rejection (biopsy proven):; ‐ overall incidence and time until first manifestation; ‐ histopathological severity (BANFF); ‐ incidence of subclinical rejection ; ‐ Renal function as determined by creatinine clearance (MDRD) at 1, 2, and 3 months.; INCLUSION CRITERIA: 1. Non‐heart‐beating‐donors (Maastricht III/IV) 2. Female patients of childbearing age agree to maintain effective birth control practice during the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Epistemonikos ID: 4683fdf0b25cc68a866848868352706a43069d83
First added on: Aug 21, 2024