NCT00239018

Brief Summary

The objective of this extension study is to allow patients being treated with enteric-coated mycophenolate sodium (core study CERL080A2405FR01) 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
144

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2003

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

April 1, 2003

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
3 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

2.3 years

First QC Date

October 12, 2005

Last Update Submit

January 28, 2011

Conditions

De Novo Kidney Transplantation

Keywords

Enteric-Coated Mycophenolate Sodium (EC-MPS), de novo, kidney transplantation, long-term safety.

Outcome Measures

Primary Outcomes (1)

  • To assess glomerular filtration rate at month 3 post transplantation

Secondary Outcomes (5)

  • Renal function of patients requiring post transplantation dialysis, experiencing slow graft function (defined as S. Creat level>264 μmol/l at D5) or with immediate graft function.

  • Incidence of patients requiring post transplantation dialysis, experience slow graft function (defined as S. Creat level>264 μmol/l at D5 or with immediate graft function.

  • Incidence of biopsy proven acute rejection, any treated acute rejection, and any treated acute rejection requiring antibody therapy, recurrent acute rejection and the severity of acute rejection episodes within 6 and 12 months

  • Incidence of graft and patient survival within 6 and 12 months

  • Safety and tolerability based on adverse event (AE) reporting.

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-FR01 and who are willing to continue treatment with Enteric-Coated Mycophenolate Sodium.

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

April 1, 2003

Primary Completion

July 1, 2005

Study Completion

July 1, 2005

Last Updated

January 31, 2011

Record last verified: 2011-01