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

Novartis

Status and phase: Completed; Phase 3

Conditions: Renal Transplant

Treatments: Drug: Mycophenolate sodium (enteric coated)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00149916

CERL080A107E

Details and patient eligibility

About

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.

Enrollment: 139 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

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)

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139 participants in 1 patient group

Mycophenolate sodium (enteric coated)

Experimental group

Treatment:

Drug: Mycophenolate sodium (enteric coated)