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NCT00149916 Clinical Trial

Follow-up Study of Safety of Enteric-coated Mycophenolate Sodium in Patients Who Successfully Completed Study CERL080A0107

Renal Transplant Clinical Trial

Official title:
Multicenter, Open-label Follow-up Study on the Safety of Enteric-coated Mycophenolate Sodium in Renal Transplant Patients.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00149916
Other study ID # CERL080A107E
Secondary ID
Status Completed
Phase Phase 3
First received September 6, 2005
Last updated November 1, 2011
Start date April 2000

Study information
Verified date November 2011
Source Novartis
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Aim of study is to provide safety and tolerability data on enteric-coated mycophenolate sodium in regard to adverse events, serious adverse events and patient and graft survival. After successful completion of the study CERL080A0107 study, patients could continue to receive enteric-coated mycophenolate sodium.

Recruitment information / eligibility
Status Completed
Enrollment 139
Est. completion date
Est. primary completion date April 2004
Accepts healthy volunteers
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Cadaveric or living donor kidney transplant recipients who completed the study CERL080A0107

Exclusion Criteria:

- Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Mycophenolate sodium (enteric coated)

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Outcome
Type Measure Description Time frame Safety issue
Primary To assess gastro-intestinal tolerability
Secondary Efficacy/safety of enteric-coated mycophenolate sodium based on AE reporting.
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