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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00171392 |
The aim of the study is to assess the safety and efficacy of enteric-coated mycophenolate sodium, given in combination with tacrolimus, after equimolar dose conversion from MMF to enteric-coated mycophenolate sodium in stable renal transplant patients.
Condition | Intervention | Phase |
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Prevention of Acute Rejection After Kidney Transplantation |
Drug: Enteric-coated mycophenolate sodium |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Open-Label Study to Evaluate the Tolerability, Safety and Efficacy of the Equimolar Conversion From Mycophenolate Mofetil (MMF) to Enteric-Coated Mycophenolate Sodium in Patients With Stable Renal Transplant Receiving Tacrolimus |
Estimated Enrollment: | 170 |
Study Start Date: | March 2004 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
Subjects expected to discontinue tacrolimus therapy;
Study ID Numbers: | CERL080AIT02 |
Study First Received: | September 12, 2005 |
Last Updated: | July 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00171392 |
Health Authority: | Italy: National Monitoring Centre for Clinical Trials - Ministry of Health |
Kidney transplantation; acute rejection; gastrointestinal adverse events; quality of life; mycophenolate sodium, tacrolimus. |
Mycophenolic Acid Mycophenolate mofetil Quality of Life Tacrolimus |
Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Therapeutic Uses Physiological Effects of Drugs |
Enzyme Inhibitors Antibiotics, Antineoplastic Immunosuppressive Agents Pharmacologic Actions |