De Novo Kidney Transplant Recipients
Conditions
Keywords
De novo Kidney Transplant recipients, enteric-coated mycophenolate sodium
Brief summary
This trial is designed to assess the efficacy, tolerability, and safety of EC-MPS in combination with cyclosporine microemulsion (CsA-ME) with or without steroids in 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
1. Males and females aged 18 to 75 years. 2. Recipients of living related kidney transplant, treated with cyclosporine, with or without corticosteroids, as primary immunosuppression. 3. Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to or at screening. Effective contraception must be used during the trial, and for 6 weeks following discontinuation of the study medication, even where there has been a history of infertility. 4. Patients who are willing and able to participate in the full course of the study and from whom written informed consent has been obtained.
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 other components of the formulation (e.g. lactose). 3. Patients with low platelet count (\< 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 who have received an investigational drug within four weeks prior to study entry. 5. Patients with a history of malignancy within the last five years, except excised squamous or basal cell carcinoma of the skin. 6. Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception. Additional protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| patient and graft survival | — |
| acute rejection incidence | — |
| graft function at 6 months post transplant. | — |
Secondary
| Measure | Time frame |
|---|---|
| influence of age, gender, and post-transplantation complications on the main clinical outcomes | — |
Outcome results
None listed