Extension Study to Assess Tolerability and Safety of Enteric-coated Mycophenolate Sodium in Renal Transplant Recipients Who Received Mycophenolate Mofetil

A One Arm, Open-label Study to Investigate the Tolerability and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in Renal Transplant Recipients Who Received Mycophenolate Mofetil (MMF)

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00238966

Enrollment

187

Registered

2005-10-14

Start date

2002-11-30

Completion date

2005-04-30

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, Enteric-Coated Mycophenolate Sodium (EC-MPS)

Brief summary

This extension study is considered to allow patients being treated with EC-MPS to collect further information on the long-term safety of this drug.

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

\- Only patients who were participating in study CERL080A2405-DE02 and have completed the first 6 months of the core study can be included in this additional extension study. Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
Safety/tolerability based on adverse events within 6 months after switching patients from MMF to optimized enteric-coated mycophenolate sodium.	—

Secondary

Measure	Time frame
Safety based on renal function within 6 months after medication switch.	—
Pharmacokinetics (PK) in a randomized subpopulation.	—
Efficacy measured by the incidence of biopsy-proven acute rejection, graft loss or death within 6 months post medication switch.	—
Efficacy measured by the incidence of biopsy-proven acute rejection 6 months post medication switch.	—
Graft survival and patient survival 6 months post medication switch.	—

Outcome results

None listed

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