Extension Study on the Safety and Efficacy of Enteric-coated Mycophenolate Sodium in Kidney Transplant Recipients

A Prospective, Open-label, Multicenter, International Follow-up Study on the Safety and Efficacy of Enteric-coated Mycophenolate Sodium (EC-MPS) in Kidney Transplant Recipients

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00239070

Enrollment

Registered

2005-10-14

Start date

2003-04-30

Completion date

2006-05-31

Last updated

2011-01-31

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

Conditions

Renal Transplantation

Keywords

EC-MPS, renal transplantation, de novo patients

Brief summary

This extension study is to assess the long-term safety of EC-MPS

Interventions

DRUGEnteric-Coated Mycophenolate Sodium (EC-MPS)

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Inclusion criteria

Inclusion /

Exclusion criteria

- All patients who completed study CERL080A2405-IN01 and who are willing to continue treatment with Enteric-Coated Mycophenolate Sodium. Other protocol-defined inclusion /

Design outcomes

Primary

Measure	Time frame
To assess patient and graft survival, acute rejection incidence, graft function and specific pertinent safety parameters in de novo renal transplant recipients.	—

Secondary

Measure	Time frame
To assess the respective influence of parameters (demographic characteristics, transplant-related variables, medical conditions and post-transplantation complications) on clinical outcomes.	—

Outcome results

None listed

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