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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00149916

Enrollment

139

Registered

2005-09-08

Start date

2000-04-30

Completion date

Unknown

Last updated

2011-11-02

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, immunosuppressants

Brief summary

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.

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

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

Exclusion criteria

* Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
To assess gastro-intestinal tolerability	—

Secondary

Measure	Time frame
Efficacy/safety of enteric-coated mycophenolate sodium based on AE reporting.	—

Outcome results

None listed

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