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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00239057 |
The aim of this study is to evaluate if the addition of EC-MPS to CsA-ME allows the safe withdrawal of the concomitant corticosteroid therapy in long-term maintenance renal allograft recipients.
All patients of the core study who are interested of being treated with EC-MPS will be included in an open-label extension study to collect further information on the long-term safety, tolerability and efficacy of this drug.
Condition | Intervention | Phase |
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Maintenance Renal Transplantation |
Drug: Enteric-Coated Mycophenolate Sodium |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Enteric-Coated Mycophenolate Sodium (EC-MPS) Administration in Maintenance Renal Transplant Patients Receiving Cyclosporine Microemulsion (CsA-ME) and Steroids, for the Withdrawal of Concomitant Steroid Therapy: a Prospective, Open-Label, Exploratory Study |
Estimated Enrollment: | 25 |
Study Start Date: | May 2002 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Inclusion criteria
1. Male or female, 18 years of age or older. 2. Recipients of first or secondary cadaver, living related or unrelated donor kidney transplant performed at least 6 month before screening (Visit 1) 3. Patients currently receiving CsA-ME and corticosteroids (at least 5 mg of prednisone equivalents) for at least 3 months prior to Screening, with or without Mycophenolate mofetil or azathioprine.
4. Serum creatinine levels < 2.3 mg/dL (=204 µmol/L) at screening and at baseline 5. Stable kidney function, i.e. increase in serum creatinine less than 20% in the last 3 months before screening and at baseline (baseline value as compared to the value obtained at screening) Exclusion Criteria
Histological evidence of acute rejection or treatment for acute rejection within the three months prior to Screening, or histological signs or clinical signs of chronic rejection (as significant proteinuria, i.e.
> 300 mg/24 hours.
Study ID Numbers: | CERL080A2405IT03 |
Study First Received: | October 12, 2005 |
Last Updated: | July 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00239057 History of Changes |
Health Authority: | Italy: National Monitoring Centre for Clinical Trials - Ministry of Health |
Renal transplantation, EC-MPS |
Cyclosporine Immunologic Factors Mycophenolate mofetil Immunosuppressive Agents Cyclosporins |
Immunologic Factors Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Mycophenolate mofetil |
Enzyme Inhibitors Immunosuppressive Agents Cyclosporins Pharmacologic Actions |