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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00788567
Other study ID # ML18496
Secondary ID
Status Completed
Phase Phase 3
First received November 10, 2008
Last updated November 2, 2015
Start date June 2005
Est. completion date May 2008

Study information

Verified date November 2015
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 136
Est. completion date May 2008
Est. primary completion date May 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
mycophenolate mofetil
1

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of patients achieving therapeutic window by Day 5\n No
Secondary 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 No
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