Study of Therapeutic Monitoring of CellCept (Mycophenolate Mofetil) After Kidney Transplantation

Condition(s) targeted: Kidney Transplantation

Intervention: mycophenolate mofetil [CellCept] (Drug); mycophenolate mofetil [CellCept] (Drug); Cyclosporine or tacrolimus (Drug); Cyclosporine or tacrolimus (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche, +1 973 235 5000

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.

Official 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

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

Percentage of patients experiencing treatment failure

Renal allograft function (by GFR)

Secondary outcome: AEs

Minimum age: 13 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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)

BIRMINGHAM, Alabama 35294, United States

LITTLE ROCK, Arkansas 72205, United States

LOS ANGELES, California 90057, United States

LOS ANGELES, California 90048, United States

SAN FRANCISCO, California 94143-0116, United States

BAKERSFIELD, California 93309, United States

DENVER, Colorado 80262, United States

GAINESVILLE, Florida 32610-0224, United States

ORLANDO, Florida 32804, United States

JACKSONVILLE, Florida 32216, United States

TAMPA, Florida 33606, United States

AUGUSTA, Georgia 30912, United States

CHICAGO, Illinois 60637, United States

INDIANAPOLIS, Indiana 46202-5124, United States

WICHITA, Kansas 67214, United States

LEXINGTON, Kentucky 40536-0293, United States

NEW ORLEANS, Louisiana 70121, United States

SHREVEPORT, Louisiana 71130, United States

BALTIMORE, Maryland 21287-8611, United States

BOSTON, Massachusetts 02215, United States

BOSTON, Massachusetts 02111, United States

SPRINGFIELD, Massachusetts 01107, United States

BURLINGTON, Massachusetts 01805, United States

WORCESTER, Massachusetts 01655, United States

ANN ARBOR, Michigan 48109-0362, United States

DETROIT, Michigan 48202-2689, United States

ROCHESTER, Minnesota 55905, United States

LIVINGSTON, New Jersey 07039, United States

HACKENSACK, New Jersey 07601, United States

BRONX, New York 10467, United States

BUFFALO, New York 14203, United States

HAWTHORNE, New York 10532, United States

NEW YORK, New York 10029, United States

NEW YORK, New York 10021, United States

ROCHESTER, New York 14642-8410, United States

CHAPEL HILL, North Carolina 27599, United States

WINSTON-SALEM, North Carolina 27157, United States

FARGO, North Dakota 58122, United States

CLEVELAND, Ohio 44106, United States

PORTLAND, Oregon 97210, United States

PITTSBURGH, Pennsylvania 15212, United States

PHILADELPHIA, Pennsylvania 19104, United States

HERSHEY, Pennsylvania 17033, United States

HARRISBURG, Pennsylvania 17101, United States

PHILADELPHIA, Pennsylvania 19102-1192, United States

PHILADELPHIA, Pennsylvania 19140, United States

PROVIDENCE, Rhode Island 02903, United States

DALLAS, Texas 75246, United States

SAN ANTONIO, Texas 78284, United States

SALT LAKE CITY, Utah 84132, United States

BURLINGTON, Vermont 05401, United States

FALLS CHURCH, Virginia 22042-3300, United States

NORFOLK, Virginia 23502, United States

SEATTLE, Washington 98104, United States

MADISON, Wisconsin 53792, United States

Ending date: January 2008
Last updated: June 17, 2008