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

Hoffmann-La Roche136 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

136

Conditions

Kidney Transplantation

Interventions

mycophenolate mofetilDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (9)

Unnamed facility

Edmonton, Alberta, Canada

Unnamed facility

Vancouver, British Columbia, Canada

Unnamed facility

Vancouver, British Columbia, Canada

Unnamed facility

Halifax, Nova Scotia, Canada

Outcomes

Primary Outcomes

Proportion of patients achieving therapeutic window by Day 5\n

Secondary Outcomes

Efficacy: Achieving therapeutic window at Day 3, maintaining therapeutic window at day of discharge, Months 1, 3, and 6\nSafety: Renal function, opportunistic infections, malignancies, and adverse events\n

Data from ClinicalTrials.gov

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