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

Novartis

Status and phase: Completed; Phase 3

Conditions: Renal Transplant

Treatments: Drug: Mycophenolate sodium (enteric coated)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00149864

CERL080A302E

Details and patient eligibility

About

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.

Enrollment: 264 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)