NCT00241059

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
183

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 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

August 1, 2002

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 14, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 18, 2005

Completed
Last Updated

January 31, 2011

Status Verified

January 1, 2011

Enrollment Period

2.4 years

First QC Date

October 14, 2005

Last Update Submit

January 28, 2011

Conditions

Renal Transplantation

Keywords

Renal transplantation, maintenance patients, tolerability, EC-MPS

Outcome Measures

Primary Outcomes (1)

  • Safety parameters and graft function in maintenance renal transplant recipients.

Secondary Outcomes (1)

  • Incidence of acute rejection episodes and graft survival in maintenance renal transplant recipients.

Study Arms (1)

EC-MPS arm

EXPERIMENTAL
Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)

Interventions

Enteric-Coated Mycophenolate Sodium (EC-MPS)DRUG
EC-MPS arm

Eligibility Criteria

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Novartis Pharmaceuticals

    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 14, 2005

First Posted

October 18, 2005

Study Start

August 1, 2002

Primary Completion

January 1, 2005

Study Completion

January 1, 2005

Last Updated

January 31, 2011

Record last verified: 2011-01