Study of Enteric-coated Mycophenolate Sodium Maintenance Therapy in Patients With Renal Transplant Receiving Cyclosporine Microemulsion and Steroids,
NCT00239057 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 23
Last updated 2011-01-31
Summary
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.
Conditions
- Maintenance Renal Transplantation
Interventions
- DRUG
-
Enteric-Coated Mycophenolate Sodium
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Novartis · Novartis
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2002-05-31
- Primary Completion
- 2005-01-31
- Completion
- 2005-01-31
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