Trial information
CLEAR study - A Study of CellCept (Mycophenolate Mofetil) in Recipients of Kidney Transplants
Status: Completed
Protocol number: ML18496
Sponsor: Hoffman-La Roche
Company division: Pharmaceutical
Official Scientific Title: 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
Brief 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.
Target sample size is 140.
Study phase: III
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: Kidney Transplantation
Intervention type: Drug
Intervention name: mycophenolate mofetil[CellCept]
Primary outcome: 1. Proportion of patients achieving therapeutic window by Day 5
Key secondary outcomes: 1. Efficacy: Achieving therapeutic window at Day 3, maintaining therapeutic window at day of discharge, Months 1, 3, and 6
Safety: Renal function, opportunistic infections, malignancies, and adverse events
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.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 08/29/2005
Date last updated: 8/29/2008
Link to trial result
This trial was conducted at the following locations:
Canada
- Edmonton, AB
- Vancouver, BC
- Halifax, NS
- Toronto, ON
- Montreal, QC
- Quebec City, QC
- Saskatoon, SK
