Efficacy and Safety of ATG-Fresenius Following a Renal Transplantation, Without Corticosteroids (NCT01324934) | Clinical Trial Compass
TerminatedPhase 3
Efficacy and Safety of ATG-Fresenius Following a Renal Transplantation, Without Corticosteroids
Stopped: Recruitment became very slow.
Portugal, Spain40 participantsStarted 2006-10
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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 c…
What they're measuring
1
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