Renal Transplant Rejection
Conditions
Keywords
acute rejection, chronic rejection, subclinical rejection, renal transplantation, steroid-free, kidney transplantation
Brief summary
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.
Interventions
DRUGATG-Fresenius S
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).
Sponsors
Eurotrials Brasil Consultores Cientificos Ltda
Recerca Clínica S.L.
PsyConsult
Neovii Biotech
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Signed and dated informed consent form, * End-stage renal disease, * Candidates for a first transplantation, * Re-transplant patients are eligible if a graft loss after transplantation was NOT due to immunological reasons, * Availability of a heart-beating cadaveric donor up to 70 years of age with a cold ischemia time shorter than 36 hours, * Male or female patients between 18 to 75 years of age inclusive, * Patients able to comply with all study related requirements, * Patients able to receive oral medication, * Women of childbearing age with a safe contraceptive method throughout the study.
Exclusion criteria
* Women who are pregnant or breast feeding, * Known Human Immunodeficiency Virus, * Hepatitis B Virus or Hepatitis C Virus infection, * Severe actual viral, bacterial or fungal infection not adequately controlled, * Patients with anamnestically known hypersensitivity to rabbit immunoglobulin antibodies or positive rabbit immunoglobulin skin test or known allergies to any component of the immunosuppressive drugs per protocol, * Patients at high immunological risk defined as current PRA \> 25% or historical PRA \> 50%, * Patients receiving pre-transplant immunosuppressive treatment, including corticosteroids, * Patients with current or history of malignancies (exception basal cell carcinoma or squamous cell carcinoma in remission), * Patients with previous transplantation except 1st graft loss due to surgical complications, * Patients receiving combined transplantation, * Patients with major organ dysfunctions, * Serious psychiatric or psychological disorders, * Pre-transplant thrombocytopenia: \< 50,000 thrombocytes/µl, Pre-transplant leukopenia: \< 2,000 leukocytes/µl, * Unable or unwilling to comply fully with the protocol, * Participation in another study of an investigational medicinal product concurrently or within the last 30 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Patient and Graft survival | 1 year |
| Safety endpoints are the incidence of AEs/SAEs and ADRs | 1 year |
| Renal function | 1 year |
| Time of onset, histological severity and incidence of steroid resistance of acute and chronic rejections | 1 year |
| Incidence and duration of initial DGF | 1 year |
Countries
Portugal, Spain
Outcome results
None listed