Follow-up Study of Safety of Enteric-coated Mycophenolate Sodium in Patients Who Successfully Completed Study CERL080A301

Renal Transplant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00149929
• Other study ID #: CERL080A301E
• Status: Completed
• Phase: Phase 3
• First received: September 6, 2005
• Last updated: February 1, 2011
• Start date: December 1999
• Est. completion date: April 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 246
• Est. completion date: April 2003
• Est. primary completion date: April 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

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	Incidence of biopsy proven acute rejection, graft loss, or death in the first six months of treatment.
Secondary	Incidence of biopsy proven acute rejection in the first six months of treatment in de novo renal transplant recipients.
Secondary	Efficacy of enteric-coated mycophenolate sodium
Secondary	Safety of enteric-coated mycophenolate sodium based on AE reporting.
Secondary	Pharmacokinetics (PK) of enteric-coated mycophenolate sodium (selected centers only).