The main objective of the study is the assessment of the overall graft rejection rate (acute, chronic and subclinical) between a treatment with ATG-Fresenius administered in addition to standard treatment consisting of CellCept® or Myfortic®/TAC and without corticosteroids and a treatment consisting of CellCept® or Myfortic®/TAC and corticosteroids during the first year after renal transplantation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Dosage: Single high-dose of 9 mg/kg pre-operatively, followed by 3 mg/kg/d at day +2 and +4. ATG-Fresenius treatment at Days 0, +2, and +4 is mandatory. (In case of persisting DGF, the treatment is left to the discretion of the investigator. Treatment options include the continuation of ATG-Fresenius treatment with 3 mg/kg/d at Day +6 and if deemed necessary also at Day +8 - but without corticosteroids).
Centro Hospitalar de Lisboa Ocidental
Carnaxide, Portugal
Hospitais da Universidade de Coimbra
Coimbra, Portugal
Hospital de Curry Cabral
Lisbon, Portugal
Hospital Geral de Santo António, SA
The primary endpoint is the incidence of biopsy-proven acute allograft rejection after 12 months, including all types of rejections like: • acute rejection • chronic rejection • subclinical rejection
Time frame: 1 year
Time of onset, histological severity and incidence of steroid resistance of acute and chronic rejections
Time frame: 1 year
Incidence and duration of initial DGF
Time frame: 1 year
Renal function
Time frame: 1 year
Patient and Graft survival
Time frame: 1 year
Safety endpoints are the incidence of AEs/SAEs and ADRs
Time frame: 1 year
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Porto, Portugal
Hospital Universitario Juan Canalejo
A Coruña, Spain
Hospital Universitari Clinic i Provincial
Barcelona, Spain
Hosptial Gregorio Maranon
Madrid, Spain
Fundación Jiménez Díaz
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain