None listed
Conditions
Interventions
experimental group Type of group
Receive Myfortic ™ at a dose of 0.72 g b.i.d. for patients over 18 years of age and 400 mg / m2 b.i.d. for children.
Patients will be instructed to administer the medication on a daily basis, that is, at 12-hour intervals, in the morning and in the evening, together with Neoral®
Sponsors
NOVARTIS BIOSCIENSES PERU S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female patients of at least 6 years of age. 2. Recipients of a primary or secondary kidney transplant of cadaveric origin, or from a related or unrelated living donor. 3. Patients currently receiving Neoral in association with MMF and corticosteroids as part of their immunosuppression regimen for at least 3 months prior to evaluation.
Exclusion criteria
Exclusion criteria: 1. Patients with multiple organ transplantation (eg, kidney and pancreas) or with a previous transplant of any other organ other than the kidney (secondary kidney transplant allowed). 2. Evidence of rejection of the graft or treatment of an episode of acute rejection within two months prior to the evaluation. 3. Patients with any known hypersensitivity to Myfortic or other components of the pharmaceutical form (eg, lactose) Patients with thrombocytopenia (<75,000 / mm2), an absolute neutrophil count <1,500 / mm2 and / or leukopenia (<2,500 / mm2), and / or hemoglobin <6.0 g / dL before recruitment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Monitoring and recording of all infections, all adverse events and all serious adverse events, regular monitoring of laboratory values of hematology, clinical chemistry and urine analyzes, and regular measurement of vital signs Measure:To evaluate the parameters related to the safety and function of the graft in the recipients of a kidney transplant in maintenance. Timepoints:throughout the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Acute rejection confirmed by biopsy Chronic rejection loss of the graft graft function Measure:To determine the efficacy, evaluated as the incidence of episodes of acute rejection and the survival of the graft, in the recipients of a renal transplant in maintenance. Timepoints:according to need | — |
Countries
Argentina, Australia, Brazil, Canada, Mexico, United States, Venezuela
Outcome results
None listed