NCT00149942

Brief Summary

This open, single arm, explorative study aims to investigate the evolution of gastrointestinal adverse events after switch from MMF to EC-MPS in organ transplanted patients suffering from gastrointestinal adverse events while on MMF therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2004

Geographic Reach
1 country

1 active site

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

October 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

November 18, 2016

Status Verified

November 1, 2016

Enrollment Period

1.8 years

First QC Date

September 6, 2005

Last Update Submit

November 16, 2016

Conditions

Kidney TransplantationLiver Transplantation

Keywords

Enteric coated mycophenolate sodiumtransplantationgastrointestinal adverse eventsKidney and liver transplantation patients experiencing GI AEs with current MMF treatment

Outcome Measures

Primary Outcomes (1)

  • Gastro-intestinal adverse events before switch versus 3 months after switch

Secondary Outcomes (5)

  • Time to the first biopsy-proven rejection after conversion.

  • Severity of biopsy-proven rejections after conversion.

  • Proportion of patients who had graft loss after conversion.

  • Frequency of adverse events

  • Frequency of infections

Interventions

Enteric-coated Mycophenolate sodium (EC-MPS)DRUG

Eligibility Criteria

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

You may qualify if:

  • Kidney or liver transplanted patients
  • Currently under MMF therapy and currently suffering from upper or lower gastro-intestinal adverse events

You may not qualify if:

  • Recent graft rejection before the study
  • Other pre-existing conditions that may cause gastro-intestinal complaints
  • Use of other drugs known to cause gastro-intestinal complaints

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis

Basel, Switzerland

Location

Study Officials

  • Novartis

    Novartis

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 8, 2005

Study Start

October 1, 2004

Primary Completion

August 1, 2006

Study Completion

August 1, 2006

Last Updated

November 18, 2016

Record last verified: 2016-11

Locations

CH(1)