Status:
COMPLETED
A One-year, Open Label Study to Investigate the Safety and the Effect of Enteric-coated Mycophenolate Sodium (EC-MPS) in Combination With Cyclosporine Microemulsion in de Novo Kidney Transplant Recipients.
Lead Sponsor:
Novartis
Conditions:
Kidney Transplantation
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
The study is a one-year prospective, open-label, safety and efficacy study. De novo renal transplant recipients will be receiving cyclosporine, 1.44g EC-MPS (720 mg b.i.d.), and corticosteroids .The s...
Eligibility Criteria
Inclusion
- Males and females aged 18-75 years. Recipients of de novo cadaveric, living unrelated or living related kidney transplants
Exclusion
- Multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any organ.
- Patients who are recipients of A-B-O incompatible transplants. Patients with a historical or current peak PRA of 50%. Patients with already existing antibodies against the HLA-type of the receiving transplant.
- Evidence of severe liver disease (incl. abnormal liver profile i.e. AST, ALT or total bilirubin 3 times UNL).
- Patients who are HIV or Hepatitis B surface antigen positive. Patients with any known hypersensitivity to mycophenolic acid, MMF, EC-MPS, 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 protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
End Date :
March 1 2006
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00154245
Start Date
January 1 2004
End Date
March 1 2006
Last Update
February 23 2017
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