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. - Article High blood pressure (hypertension)
Clinical Trial: 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.
This study is no longer recruiting patients.
|Kidney Transplantation || Drug: Enteric-Coated Mycophenolate sodium (EC-MPS) ||Phase IV |
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Study Type: Interventional
Study Design: Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Study start: November 2003
- Males and females aged 18-75 years.
- Recipients of de novo cadaveric, living unrelated or living related kidney transplants
- 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.
Novartis, Study Director, Novartis
Last Updated: September 9, 2005
Record first received: September 8, 2005
ClinicalTrials.gov Identifier: NCT00154245
Health Authority: Taiwan: Department of Health
ClinicalTrials.gov processed this record on 2005-09-13
- High Blood Pressure and Kidney Disease (National Institute of Diabetes and Digestive and Kidney Diseases)