NCT00239070

Brief Summary

This extension study is 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
69

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2003

Typical duration for phase_3

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

April 1, 2003

Completed
2.5 years 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
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

January 31, 2011

Status Verified

January 1, 2011

Enrollment Period

3.1 years

First QC Date

October 12, 2005

Last Update Submit

January 28, 2011

Conditions

Renal Transplantation

Keywords

EC-MPS, renal transplantation, de novo patients

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

Enteric-Coated Mycophenolate Sodium (EC-MPS)DRUG

Eligibility Criteria

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Novartis

    Novartis

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
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

April 1, 2003

Primary Completion

May 1, 2006

Study Completion

May 1, 2006

Last Updated

January 31, 2011

Record last verified: 2011-01