Not Signed In -
Nafcillin Sodium Injection |
Nallpen; Unipen Injection |
Clinical Trial: Follow-Up Study of Safety of Enteric-Coated Mycophenolate Sodium in Patients Who Successfully Completed Study CERL080A301
This study is no longer recruiting patients.
|
Purpose
Aim of study is to collect long term safety and tolerability data on enteric-coated mycophenolate sodium with regard to adverse events, serious adverse events, and patient and graft survival. After successful completion of study CERL080A301 study, patients who previously were on enteric-coated mycophenolate sodium or MMF were given opportunity to remain on enteric-coated mycophenolate sodium or convert from MMF to enteric-coated mycophenolate sodium.
| Condition | Intervention | Phase |
|---|---|---|
| Renal transplant | Drug: Mycophenolate sodium (enteric coated) | Phase III |
MedlinePlus consumer health information
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title: Multicenter, Open-Label Follow-Up Study on the Safety of Enteric-Coated Mycophenolate Sodium in De Novo Renal Transplant Patients
Further Study Details:
Study start: December 1999
Eligibility
Ages Eligible for Study: 18 Years - 75 Years, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
-First cadaveric, living unrelated or human antigen mismatched living related donor kidney transplant recipients who completed study CERL080A301
Exclusion Criteria:
- Other protocol-defined inclusion/exclusion criteria may apply.
Location Information
Study chairs or principal investigators
Novartis, Study Director, Novartis
More Information
Study ID Numbers: CERL080A301E
Last Updated: September 7, 2005
Record first received: September 6, 2005
ClinicalTrials.gov Identifier: NCT00149929
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13
Last Updated: September 7, 2005
Record first received: September 6, 2005
ClinicalTrials.gov Identifier: NCT00149929
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13
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