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Conversion Trial From Mycophenolate Mofetil (MMF) to Enteric-coated Mycophenolate Sodium (EC-MPS) in Stable Transplanted Patients Suffering From Gastrointestinal (GI) Adverse Events While on Mycophenolate Mofetil Therapy (MMF) Therapy

NCT ID: NCT00149942

Last Updated: 2016-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2006-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Kidney Transplantation Liver Transplantation

Keywords

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Enteric coated mycophenolate sodium transplantation gastrointestinal adverse events Kidney and liver transplantation patients experiencing GI AEs with current MMF treatment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Enteric-coated Mycophenolate sodium (EC-MPS)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Principal Investigators

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Novartis

Role: STUDY_DIRECTOR

Novartis

Locations

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Novartis

Basel, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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CERL080ABE01

Identifier Type: -

Identifier Source: org_study_id