Efficacy and Safety of ATG-Fresenius Following a Renal Transplantation, Without Corticosteroids

• Status: Terminated
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Neovii Biotech
• Collaborators: Eurotrials Brasil Consultores Cientificos Ltda; PsyConsult; Recerca Clínica S.L.

Criteria

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.