NCT00238940

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
55

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 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

February 1, 2003

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
1 month 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

2.6 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)

  • Efficacy based on level of serum creatinine and calculated creatinine clearance 6 months post transplantation.

Secondary Outcomes (5)

  • Efficacy based on the level of serum creatinine and calculated creatinine clearance 12 months post transplantation.

  • Safety and tolerability of enteric-coated mycophenolate sodium at 6 and 12 months post transplantation

  • Pharmacokinetics enteric coated mycophenolate sodium in a randomized subgroup

  • Efficacy based on the incidence of biopsy-proven acute rejection, graft loss or death 6 and 12 months post transplantation.

  • Efficacy based on the incidence of biopsy-proven acute rejection at 6 and 12 months post transplantation.

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:

  • \- All patients who completed study CERL080A2405-DE01 and who are willing to continue treatment with EC-MPS.

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

February 1, 2003

Primary Completion

September 1, 2005

Study Completion

September 1, 2005

Last Updated

January 31, 2011

Record last verified: 2011-01