Know Cancer

or
forgot password

A Randomized, Open-label Study of the Achievement of a Mycophenolic Acid Therapeutic Window During Treatment With 2 Dosing Regimens of Oral CellCept Administered as a Component of Standard Immunosuppressive Therapy in Patients With Kidney Transplants


Phase 3
18 Years
N/A
Not Enrolling
Both
Kidney Transplantation

Thank you

Trial Information

A Randomized, Open-label Study of the Achievement of a Mycophenolic Acid Therapeutic Window During Treatment With 2 Dosing Regimens of Oral CellCept Administered as a Component of Standard Immunosuppressive Therapy in Patients With Kidney Transplants


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Proportion of patients achieving therapeutic window by Day 5\n

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Chair

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Canada: Health Canada

Study ID:

ML18496

NCT ID:

NCT00788567

Start Date:

June 2005

Completion Date:

May 2008

Related Keywords:

  • Kidney Transplantation

Name

Location