Renal Transplant
Conditions
Interventions
Trade Name: Rapamune
Product Name: Rapamune
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Sirolimus
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Tr
Sponsors
Roche Farma S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: – Patients who are males or non-pregnant females > 18 years old. – Patients who are recipients of primary kidney allografts. – Patients who are single-organ recipients (kidney only). – Patients with PRA =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: – Patients previously treated with Daclizumab, MMF or SRL. – Patients who require in addition to the study immunosuppresive regimen anti-lymphocyte preparations for induction therapy. – Women lactating, pregnant or of childbearing potential not using a reliable contraceptive method during the study. – Patients with severe gastrointestinal disorders that interfere with Their ability to receive or absorb oral medication and patients with severe diarrhoea. – Patients who are expected than to require oral corticosteroids post-transplant (i.e. patients suffering autoinmune diseases). – Patients with active peptic ulcer disease. – Patients receiving bile-acid sequestrants. – Patients with severe anemia (Hb<6 g/dl), leucopenia (WBC<2500/mm3) or thrombocytopenia (Tc<100’000/mm3) – Patients with a history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study. – HIV positive donor or patient – Patients with history of malignancy within the last 5 years, except localised and treated non melanoma skin cancer, treated and without recidive evidence. – Patients for whom the investigator considers a treatment with the following medications necessary: ? Azathioprine, ? methotrexate ? cyclophosphamide, ? Cyclosporine ? Tacrolimus ? Everolimus ? Mycophenolate sodium ? polyclonal and monoclonal anti-lymphocyte antibodies other than daclizumab (e.g. OKT3, ATG, basiliximab) – Known hypersensitivity or absolute contraindications to any of the medications administered in the context of the study or any other substances present in the study medications – Patients who require concomitant treatment with other investigational or prohibited drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of a steroid free regimen against normal doses of corticosteroids for prevention of acute rejection, when given in conjunction with daclizumab, mycophenolate mofetil (MMF) and sirolimus as maintenance therapy in the management of renal allograft recipients.;Secondary Objective: To assess clinical efficacy and safety of the two treatment regimens ;Primary end point(s): Proportion of patients experiencing a biopsy proven acute rejection episode 6 months post-randomization | — |
Countries
Spain
Outcome results
None listed