Renal Transplant
Conditions
Brief summary
Purpose of study is to compare the efficacy of enteric-coated mycophenolate sodium compared to mycophenolate mofetil in Chinese patients (study conducted in China) as measured by the incidence of biopsy proven acute rejection, graft loss, or death within six months of treatment in de novo renal transplant patients.
Interventions
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Inclusion criteria
* Recipients of first, cadaveric (with donor written consent form) or living related non-HLA identical donor kidney transplant, * treated with cyclosporine and corticosteroids as primary immunosuppression.
Exclusion criteria
* Second or subsequent kidney transplant or multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any other organ * Patients who have received an investigational drug within four weeks prior to study entry Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy of EC-MPS compared to MMF in Chinese patients as measured by the incidence of biopsy proven acute rejection, graft loss, or death within six months of treatment in de novo renal transplant recipients. | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of biopsy proven acute rejection within six months of treatment in de novo renal transplant recipients | — |
| Other variables of efficacy: chronic rejection, graft loss, death. | — |
| Safety of EC-MPS as measured by incidence of adverse events and serious adverse events. | — |
Countries
China
Outcome results
None listed