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A Study of CellCept (Mycophenolate Mofetil) in Kidney Transplant Patients Switched From EC-MPS.

NCT ID: NCT00420472

Last Updated: 2007-11-20

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

TERMINATED

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Brief Summary

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This study will assess the safety, efficacy and effect on quality of life of switching kidney transplant patients from reduced dose EC-MPS treatment due to gastrointestinal problems to a higher than the equimolar dose of CellCept. Patients will be switched, initially, from EC-MPS (\<1440g/day) to an equimolar dose of CellCept, and at the next visit (day 10 +/- 5) the CellCept dose will be increased by 250mg/day, and the daily dose will be split into 3-4 doses. The anticipated time on study treatment is \<3 months, and the target sample size is \<100 individuals.

Detailed Description

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Conditions

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Kidney Transplantation

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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mycophenolate mofetil [CellCept]

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* adult patients, \>=18 years of age;
* first or second kidney transplant;
* EC-MPS therapy for \>=6 months, with a stable dose for \>=2 months;
* lower than recommended dose of EC-MPS (\<1440g/day) due to gastrointestinal complaints.

Exclusion Criteria

* patients who have participated in this study before;
* patients currently participating in another clinical trial, or who participated in one during the last 30 days.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Berlin, , Germany

Site Status

Berlin, , Germany

Site Status

Cologne, , Germany

Site Status

Dresden, , Germany

Site Status

Essen, , Germany

Site Status

Hanover, , Germany

Site Status

Münster, , Germany

Site Status

Countries

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Germany

Other Identifiers

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ML20240

Identifier Type: -

Identifier Source: org_study_id