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Extension Study to Assess Tolerability and Safety of Enteric-coated Mycophenolate Sodium in Renal Transplant Recipients Who Received Mycophenolate Mofetil

NCT ID: NCT00238966

Last Updated: 2011-01-31

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

187 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-30

Study Completion Date

2005-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Renal Transplantation

Keywords

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Renal transplantation, Enteric-Coated Mycophenolate Sodium (EC-MPS)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Enteric-Coated Mycophenolate Sodium (EC-MPS)

Intervention Type DRUG

Eligibility Criteria

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Exclusion Criteria

\- Only patients who were participating in study CERL080A2405-DE02 and have completed the first 6 months of the core study can be included in this additional extension study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 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

Other Identifiers

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CERL080A2405DE02E1

Identifier Type: -

Identifier Source: org_study_id