A randomized, open-label, multi-center study comparing a steroid sparing regimen versus standard steroid regimen in combination with daclizumab, mycophenolate mofetil and sirolimus in the prevention of acute renal allograft rejection.Estudio abierto, aleatorizado, multicéntrico, nacional, comparando un régimen libre de esteroides frente a un régimen de esteroides estándar, en combinación con Daclizumab, Micofenolato Mofetil y Sirolimus, en la prevención del rechazo agudo en trasplante renal.
- Conditions
- Renal Transplant
- Registration Number
- EUCTR2005-003383-39-ES
- Lead Sponsor
- Roche Farma S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 144
–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 <20%
–If patients are women of childbearing potential, they must have a negative pregnancy test, and use a reliable form of contraception
–Patients and their guardians must be capable of understanding the purpose and risks of the study.
–Patients who are willing to give written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
–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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br>;Primary end point(s): Proportion of patients experiencing a biopsy proven acute rejection episode 6 months post-randomization
- Secondary Outcome Measures
Name Time Method