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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00239083 |
The aim of MYFORMS is to assess efficacy and safety on clinical outcomes of EC-MPS in combination with Cyclosporine microemulsion (CsA-ME) in kidney transplant recipients.
Condition | Intervention | Phase |
---|---|---|
Kidney Transplantation |
Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS) |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase IV Study of Efficacy and Safety of Enteric-Coated Mycophenolate Sodium (EC-MPS) in Combination With Cyclosporine Microemulsion (CsA-ME) in Kidney Transplant Patients |
Estimated Enrollment: | 40 |
Study Start Date: | January 2005 |
Ages Eligible for Study: | 6 Years and older |
Genders Eligible for Study: | Both |
De Novo-Inclusion criteria
Maintenance-Inclusion criteria
De Novo and Maintenance-Exclusion Criteria
Other protocol-defined inclusion/exclusion criteria may apply
Responsible Party: | Novartis ( Novartis ) |
Study ID Numbers: | CERL080ATR01 |
Study First Received: | October 12, 2005 |
Last Updated: | September 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00239083 |
Health Authority: | Turkey: Ministry of Health |
MYFORMS, Kidney Transplantation, Enteric-Coated Mycophenolate Sodium (EC-MPS), Cyclosporine microemulsion (CsA-ME) |
Cyclosporine Mycophenolate mofetil Cyclosporins |
Immunologic Factors Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions |