Renal Transplant
Conditions
Keywords
Renal Transplant, adults, immunosuppressant
Brief summary
Aim of study is to collect long term safety and tolerability data on enteric-coated mycophenolate sodium with regard to adverse events, serious adverse events, and patient and graft survival. After successful completion of study CERL080A301 study, patients who previously were on enteric-coated mycophenolate sodium or MMF were given opportunity to remain on enteric-coated mycophenolate sodium or convert from MMF to enteric-coated mycophenolate sodium.
Interventions
Sponsors
Novartis
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
-First cadaveric, living unrelated or human antigen mismatched living related donor kidney transplant recipients who completed study CERL080A301
Exclusion criteria
* Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of biopsy proven acute rejection, graft loss, or death in the first six months of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of biopsy proven acute rejection in the first six months of treatment in de novo renal transplant recipients. | — |
| Efficacy of enteric-coated mycophenolate sodium | — |
| Safety of enteric-coated mycophenolate sodium based on AE reporting. | — |
| Pharmacokinetics (PK) of enteric-coated mycophenolate sodium (selected centers only). | — |
Outcome results
None listed