Renal Transplantation
Conditions
Keywords
Kidney transplantation, enteric-coated mycophenolate sodium
Brief summary
Clinical trial for the novo transplant recipients, which aims to assess tolerability and safety and clinical outcomes of EC-MPS in combination with cyclosporine microemulsion (CsA-ME) with or without steroids in a population of kidney transplant recipients.
Interventions
DRUGEnteric-Coated Mycophenolate Sodium (EC-MPS)
Sponsors
Novartis
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Inclusion criteria
* Male and females aged 18 to 75 * Recipients of cadaveric, living unrelated or living related kidney transplant, treated with CsA-ME, with or without corticosteroids, as primary immunosuppression
Exclusion criteria
* Multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any organ, other than kidney. * Patients with any known hypersensitivity to MPA, EC-MPS or other components of the formulation (e.g. lactose). * Patients with thrombocytopenia (\< 75,000/mm3), with an absolute neutrophil count of \< 1,500/mm3, and/or leukocytopenia (\< 2,500/mm3), and/or hemoglobin \< 6 g/dL at Screening or Baseline. Other inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6 Month evaluation | — |
| patient and graft survival | — |
| acute rejection (suspected or biopsy confirmed) | — |
| graft function (serum creatinine, calculated creatinine clearance and glomerular filtration rate), | — |
| infections, adverse events, serious adverse events. | — |
Secondary
| Measure | Time frame |
|---|---|
| Influence of parameters: demography, medical conditions, complications post transplantation on main clinical outcomes. 6 month evaluation | — |
Countries
Switzerland
Outcome results
None listed