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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00149864

Enrollment

264

Registered

2005-09-08

Start date

2000-02-29

Completion date

2003-12-31

Last updated

2011-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Transplant

Keywords

Renal Transplant, adults, immunosuppressant

Brief 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.

Interventions

DRUGMycophenolate sodium (enteric coated)

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Inclusion criteria

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

Exclusion criteria

* Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Safety/efficacy based on adverse event (AE) reporting.	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026