Follow-up Study of Safety of Enteric-coated Mycophenolate Sodium in Patients Who Successfully Completed Study CERL080A302

Renal Transplant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00149864
• Other study ID #: CERL080A302E
• Status: Completed
• Phase: Phase 3
• First received: September 6, 2005
• Last updated: February 1, 2011
• Start date: February 2000
• Est. completion date: December 2003

Study information

• Verified date: February 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 collect long term safety data on enteric-coated mycophenolate sodium 720 mg bid in combination with cyclosporine with/without steroids in regard to adverse events, serious adverse events, and patient and graft survival. After successful completion of the study CERL080A302, patients who previously were receiving enteric-coated mycophenolate sodium or MMF were given opportunity to remain on enteric-coated mycophenolate sodium or convert MMF to enteric-coated mycophenolate sodium.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 264
• Est. completion date: December 2003
• Est. primary completion date: December 2003
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

-First cadaveric, living unrelated or living related donor kidney transplant recipients who completed study CERL080A302

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

• Renal Transplant

Intervention

Drug:
• Mycophenolate sodium (enteric coated)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the incidence and severity of GI adverse events (AEs) and neutropenia in the first 3 months of treatment in maintenance renal transplant patients.
Secondary	Safety/efficacy based on adverse event (AE) reporting.