Status:
COMPLETED
Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in de Novo Kidney Transplant Recipients
Lead Sponsor:
Novartis
Conditions:
De Novo Kidney Transplant Recipients
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- Inclusion criteria
- Males and females aged 18 to 75 years.
- Recipients of living related kidney transplant, treated with cyclosporine, with or without corticosteroids, as primary immunosuppression.
- 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.
- 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:
- Multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any organ, other than kidney.
- Patients with any known hypersensitivity to other components of the formulation (e.g. lactose).
- 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.
- Patients who have received an investigational drug within four weeks prior to study entry.
- Patients with a history of malignancy within the last five years, except excised squamous or basal cell carcinoma of the skin.
- 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/exclusion criteria may apply
Exclusion
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2005
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00312143
Start Date
February 1 2004
End Date
October 1 2005
Last Update
February 2 2011
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