Extension Study of 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 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00241059

Enrollment

183

Registered

2005-10-18

Start date

2002-08-31

Completion date

2005-01-31

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

Renal transplantation, maintenance patients, tolerability, EC-MPS

Brief summary

The objective of this extension study is to allow patients being treated with enteric-coated mycophenolate sodium (core study CERL080A2405LA01) to continue on the same treatment and 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 No maximum

Healthy volunteers

Inclusion criteria

* All patients who completed study CERL080A2405-LA01 and who are willing to continue treatment with Enteric-Coated Mycophenolate Sodium.

Exclusion criteria

* Other protocol-defined inclusion /

Design outcomes

Primary

Measure	Time frame
Safety parameters and graft function in maintenance renal transplant recipients.	—

Secondary

Measure	Time frame
Incidence of acute rejection episodes and graft survival in maintenance renal transplant recipients.	—

Outcome results

None listed

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