NCT00238966

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
187

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2002

Typical duration for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2002

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 14, 2005

Completed
Last Updated

January 31, 2011

Status Verified

January 1, 2011

Enrollment Period

2.4 years

First QC Date

October 12, 2005

Last Update Submit

January 28, 2011

Conditions

Renal Transplantation

Keywords

Renal transplantation, Enteric-Coated Mycophenolate Sodium (EC-MPS)

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (5)

  • 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.

Interventions

Enteric-Coated Mycophenolate Sodium (EC-MPS)DRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • \- 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Novartis

    Novartis

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 12, 2005

First Posted

October 14, 2005

Study Start

November 1, 2002

Primary Completion

April 1, 2005

Study Completion

April 1, 2005

Last Updated

January 31, 2011

Record last verified: 2011-01