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Sponsored by: |
Novartis |
Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00537862 |
This study will evaluate the efficacy and safety of enteric-coated mycophenolate sodium (EC-MPS) in a cyclosporine microemulsion based regimen with C2 monitoring in de novo kidney transplant recipients
Condition | Intervention | Phase |
Kidney Transplant |
Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS) |
Phase IV |
MedlinePlus related topics: | Kidney Transplantation |
Drug Information available for: | Cyclosporine Cyclosporin Mycophenolate Mofetil Mycophenolate mofetil hydrochloride Mycophenolate sodium |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Efficacy and Safety of Enteric-Coated Mycophenolate Sodium (EC-MPS) in Cyclosporine Microemulsion Based Regimen in de Novo Living Donor Kidney Transplant Recipients ; A Prospective, Open Label, Multi-Center Study |
Enrollment: | 200 |
Study Start Date: | May 2006 |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
Korea, Republic of | |||||
Novartis Investigative Site | |||||
Seoul, Korea, Republic of, (138-736) | |||||
Novartis Investigative Site | |||||
Seoul, Korea, Republic of, (120-752) | |||||
Novartis Investigative Site | |||||
Seoul, Korea, Republic of, (137-701) | |||||
Novartis Investigative Site | |||||
Daegu, Korea, Republic of, (700-721) | |||||
Novartis Investigative Site | |||||
Jeollanam-do, Korea, Republic of, (501-757) | |||||
Novartis Investigative Site | |||||
Seoul, Korea, Republic of, (110-744) | |||||
Novartis Investigative Site | |||||
Busan, Korea, Republic of, (614-735) | |||||
Novartis Investigative Site | |||||
Daegu, Korea, Republic of, (700-712) |
Novartis |
Study Director: | Novartis | Novartis |
Study ID Numbers: | CERL080AKR02 |
First Received: | October 1, 2007 |
Last Updated: | October 1, 2007 |
ClinicalTrials.gov Identifier: | NCT00537862 |
Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
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