CLEAR Study - A Study of CellCept (Mycophenolate Mofetil) in Recipients of Kidney Transplants

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

PHASE3

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2008-05-31

Brief Summary

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This study will compare the efficacy and safety of 2 dosing regimens of oral CellCept administered as a component of standard immunosuppressive therapy in recipients of kidney transplants. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

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Detailed Description

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Conditions

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Kidney Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

mycophenolate mofetil

Intervention Type DRUG

1

Interventions

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mycophenolate mofetil

1

Intervention Type DRUG

Other Intervention Names

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CellCept

Eligibility Criteria

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Inclusion Criteria

* adult patients \>=18 years of age;
* recipients of a primary kidney transplant.

Exclusion Criteria

* positive for HIV-1, human T-cell leukemia/lymphoma virus-1 (HTLV-1), or hepatitis B surface antigen;
* positive for hepatitis C virus, with moderate or severe liver disease;
* active malignancy or history of malignancy, excluding skin cancer (basal or squamous cell) that has been adequately treated;
* need for maintenance corticosteroids for another condition.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No