Kidney Transplantation
Conditions
Keywords
MYFORMS, Kidney Transplantation, Enteric-Coated Mycophenolate Sodium (EC-MPS), Cyclosporine microemulsion (CsA-ME)
Brief summary
The aim of MYFORMS is to assess efficacy and safety on clinical outcomes of EC-MPS in combination with Cyclosporine microemulsion (CsA-ME) in kidney transplant recipients.
Interventions
DRUGEnteric-Coated Mycophenolate Sodium (EC-MPS)
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
Inclusion criteria
De Novo-Inclusion criteria 1. Males and females aged 6 years or over. 2. Recipients of cadaveric, living unrelated or living related kidney transplant, treated with CsA-Me, with or without corticosteroids, as primary immunosuppression. Maintenance-Inclusion criteria 1. Males and females aged 6 years or over. 2. Recipients of first or secondary cadaveric, living related or unrelated donor kidney transplant. 3. Patients currently receiving CsA-ME with or without Mycophenolate mofetil (MMF) or azathioprine, with or without corticosteroids as part of their immunosuppressive regimen for at least 3 months prior to Screening. 4. Patients in a stable condition in terms of graft function (serum creatinine not above 2.3 mg/dL (=204 µmol/L) at screening and at baseline, or not increased by more than 20% at baseline compared to values obtained at screening), no change of immune suppressive regimen due to graft malfunction, and any known clinically significant physical and/or laboratory changes for at least 2 months prior to enrollment. De Novo and Maintenance-
Exclusion criteria
1. Multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any organ other than kidney. 2. Patients with any known hypersensitivity to MPA, EC-MPS or other components of the formulation (e.g. lactose). 3. 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. 4. Patients with a history of malignancy within the last five years, except excised squamous or basal cell carcinoma of the skin. Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| patient and graft survival | — |
| acute rejection incidence | — |
| graft function | — |
| safety | — |
Secondary
| Measure | Time frame |
|---|---|
| influence of demographic characteristics, transplant-related variables, medical conditions and post-transplantation complications on the main clinical outcomes, according to the immunosuppressive regimen used. | — |
Countries
Switzerland
Outcome results
None listed