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Trial information
Study of Therapeutic Monitoring of CellCept (Mycophenolate Mofetil) After Kidney Transplantation
Status: Completed
Protocol number: ML17225
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label study of various dosing regimens of CellCept combined with various dosing regimens of cyclosporine or tacrolimus on treatment failure in kidney transplantation patients
Brief summary: This 3 arm study will evaluate the efficacy and safety of various dosing regimens of CellCept combined with various dosing regimens of cyclosporine or tacrolimus in kidney transplantation patients. Patients will be randomized to one of 3 dosing regimens to receive concentration-controlled CellCept with reduced cyclosporine or tacrolimus, concentration-controlled CellCept with standard cyclosporine or tacrolimus, or fixed-dose CellCept (1g bid) with standard cyclosporine or tacrolimus. The anticipated time on study treatment is 1-2 years, and the target sample size is 500+ individuals.
Target sample size is
720.
Study phase: IV
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. Percentage of patients experiencing treatment failure Time frame: Within 12 months post-transplant
2. Renal allograft function (by GFR) Time frame: 12 months
Key secondary outcomes: 1. AEs Time frame: Throughout study
Inclusion criteria: - male or female patients 13-75 years of age
- single organ recipient (kidney only) from living (related or unrelated) or cadaveric heart-beating donors
- patient receiving first or second kidney transplant
Exclusion criteria: - immunosuppressive therapy (except corticosteroid treatment) within previous 28 days for a first transplant and 3 months for a second transplant
- history of malignancy in last 5 years (except successfully treated localized non-melanoma skin cancer)
Gender: Males or Females
Age limits: Min: 13 Years Max: 75 Years
Accepts healthy volunteers: No
Trial registration date: 08/26/2005
Date last updated: 11/21/2008
Link to trial result
This trial was conducted at the following locations:United States - Birmingham, AL
- Little Rock, AR
- Los Angeles, CA
- San Francisco, CA
- Denver, CO
- Gainesville, FL
- Jacksonville, FL
- Orlando, FL
- Tampa, FL
- Augusta, GA
- Chicago, IL
- Indianapolis , IN
- Wichita, KS
- Lexington, KY
- Boston, MA
- Springfield, MA
- Ann Arbor, MI
- Detroit, MI
- Rochester, MN
- Hackensack, NJ
- Livingston, NJ
- Buffalo, NY
- Hawthorne, NY
- New York, NY
- Rochester, NY
- Chapel Hill, NC
- Winston-Salem, NC
- Fargo, ND
- Cleveland, OH
- Portland, OR
- Harrisburg, PA
- Philadelphia, PA
- Providence, RI
- Dallas, TX
- San Antonio, TX
- Salt Lake City, UT
- Burlington, VT
- Falls Church, VA
- Norfolk , VA
- Seattle, WA
- Madison, WI
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