Kidney de Novo Transplant
Conditions
Keywords
Kidney, de novo transplant, steroid withdrawal, adults, EC-MPS and cyclosporine
Brief summary
All patients of the core study who are interested of being treated with EC-MPS will be included in an open-label extension study to collect further information on the long-term safety, tolerability and efficacy of this drug. The purpose of this study is to evaluate the feasibility of steroid withdrawal in the setting of immunosuppression with a combination of EC-MPS, cyclosporine and steroids in de novo kidney allograft recipients.
Interventions
DRUGEnteric-coated Mycophenolate sodium (EC-MPS)
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Inclusion criteria
* Male or female patients undergoing first kidney transplant. * Patients aged 18 -70 years. * Patients receiving an ABO identical or compatible graft.
Exclusion criteria
* Multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any organ other than kidney. * Positive HBsAg test * Pre-Transplant PRA \>50% or historical PRA \>75% Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| biopsy proven acute rejection incidence at 1 year post-transplantation | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient and graft survival at 1 year | — |
| Incidence of biopsy proven acute rejection episodes at 6 months | — |
| Incidence of treated rejection episodes at 6 months and 1 year | — |
| Cardiovascular profile (as measured by Cholesterol, HbA1, Glucose, incidence of HTA) | — |
| Percentage of patients free from steroids at 6 months and 1 year | — |
| Incidence of steroid-resistant episodes at 6 months and 1 year | — |
| Treatment safety | — |
Outcome results
None listed