Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This extension study is considered to allow patients being treated with EC-MPS to collect further information on the long-term safety of this drug.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enteric-Coated Mycophenolate Sodium (EC-MPS) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy based on level of serum creatinine and calculated creatinine clearance 6 months post transplantation. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy based on the level of serum creatinine and calculated creatinine clearance 12 months post transplantation. | ||
| Safety and tolerability of enteric-coated mycophenolate sodium at 6 and 12 months post transplantation |
Not provided
Inclusion/ Exclusion criteria
- All patients who completed study CERL080A2405-DE01 and who are willing to continue treatment with EC-MPS.
Other protocol-defined inclusion/exclusion criteria may apply.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Novartis | Novartis | Study Director |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Pharmacokinetics enteric coated mycophenolate sodium in a randomized subgroup |
| Efficacy based on the incidence of biopsy-proven acute rejection, graft loss or death 6 and 12 months post transplantation. |
| Efficacy based on the incidence of biopsy-proven acute rejection at 6 and 12 months post transplantation. |