None listed
Conditions
Interventions
Patients in maintenance treatment with Neoral, in whom the detailed retrospective data will be collected, in addition to the prospective evaluations.
Receptors of a de novo organ with collection of prospective data only.
Group name:GROUP III Type of group
Sponsors
NOVARTIS BIOSCIENSES PERU S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: • Man or woman who is a recipient of a de novo transplant or who is in the maintenance phase. • The prescribed and prescribed immunosuppression regimen should be based on the use of Neoral. • The patient has given written informed consent (if required or if appropriate).
Exclusion criteria
Exclusion criteria: • Patients who are currently receiving a non-patented medication research or planning to participate in a study with a research drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:• Clinical and laboratory parameters used to evaluate the function of the graft • Occurrence of acute rejection • Chronic rejection • Graft loss (moment and main cause) • Death (moment and cause) Measure:Maintenance of an optimal graft function and in the necessary medication adjustments Timepoints:Months 1, 3, 6 and 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Late graft function, cardiovascular diseases, infections, neoplasms and other relevant complications that affect the graft or specific body systems. Measure:Postransplant-specific complications that affect the function of the graft or the outcome of the patient. Timepoints:Months 1, 3, 6 and 12 | — |
Countries
Australia, Canada, United States
Outcome results
None listed