Study of Therapeutic Monitoring of CellCept (Mycophenolate Mofetil) After Kidney Transplantation - Full Text View

Sponsor:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00087581

Purpose

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.

Condition	Intervention	Phase
Kidney Transplantation	Drug: mycophenolate mofetil [CellCept] Drug: Cyclosporine or tacrolimus	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Cyclosporine Cyclosporin Tacrolimus anhydrous Tacrolimus Mycophenolate mofetil hydrochloride Mycophenolate Mofetil

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Percentage of patients experiencing treatment failure [ Time Frame: Within 12 months post-transplant ] [ Designated as safety issue: No ]
Renal allograft function (by GFR) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

AEs [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment:	717
Study Completion Date:	January 2008

Arms	Assigned Interventions
1: Experimental	Drug: mycophenolate mofetil [CellCept] Concentration-controlled Drug: Cyclosporine or tacrolimus Reduced
2: Experimental	Drug: mycophenolate mofetil [CellCept] Concentration-controlled Drug: Cyclosporine or tacrolimus Standard, as prescribed
3: Experimental	Drug: mycophenolate mofetil [CellCept] 1g po bid Drug: Cyclosporine or tacrolimus Standard, as prescribed

Eligibility

Ages Eligible for Study:	13 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00087581

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Locations

United States, Alabama

BIRMINGHAM, Alabama, United States, 35294
United States, Arkansas

LITTLE ROCK, Arkansas, United States, 72205
United States, California

LOS ANGELES, California, United States, 90057

LOS ANGELES, California, United States, 90048

SAN FRANCISCO, California, United States, 94143-0116

BAKERSFIELD, California, United States, 93309
United States, Colorado

DENVER, Colorado, United States, 80262
United States, Florida

GAINESVILLE, Florida, United States, 32610-0224

ORLANDO, Florida, United States, 32804

MIAMI, Florida, United States, 33101

JACKSONVILLE, Florida, United States, 32216

TAMPA, Florida, United States, 33606
United States, Georgia

AUGUSTA, Georgia, United States, 30912
United States, Illinois

CHICAGO, Illinois, United States, 60637
United States, Indiana

INDIANAPOLIS, Indiana, United States, 46202-5124
United States, Kansas

WICHITA, Kansas, United States, 67214
United States, Kentucky

LEXINGTON, Kentucky, United States, 40536-0293
United States, Louisiana

NEW ORLEANS, Louisiana, United States, 70121

SHREVEPORT, Louisiana, United States, 71130
United States, Maryland

BALTIMORE, Maryland, United States, 21287-8611
United States, Massachusetts

BOSTON, Massachusetts, United States, 02215

BOSTON, Massachusetts, United States, 02111

SPRINGFIELD, Massachusetts, United States, 01107

BURLINGTON, Massachusetts, United States, 01805

WORCESTER, Massachusetts, United States, 01655
United States, Michigan

ANN ARBOR, Michigan, United States, 48109-0362

DETROIT, Michigan, United States, 48202-2689
United States, Minnesota

ROCHESTER, Minnesota, United States, 55905
United States, New Jersey

LIVINGSTON, New Jersey, United States, 07039

HACKENSACK, New Jersey, United States, 07601
United States, New York

BRONX, New York, United States, 10467

BUFFALO, New York, United States, 14203

NEW YORK, New York, United States, 10021

NEW YORK, New York, United States, 10029

NEW YORK, New York, United States, 10032

HAWTHORNE, New York, United States, 10532

ROCHESTER, New York, United States, 14642-8410
United States, North Carolina

CHAPEL HILL, North Carolina, United States, 27599

WINSTON-SALEM, North Carolina, United States, 27157
United States, North Dakota

FARGO, North Dakota, United States, 58122
United States, Ohio

CLEVELAND, Ohio, United States, 44106
United States, Oregon

PORTLAND, Oregon, United States, 97210
United States, Pennsylvania

PITTSBURGH, Pennsylvania, United States, 15212

PHILADELPHIA, Pennsylvania, United States, 19104

HERSHEY, Pennsylvania, United States, 17033

HARRISBURG, Pennsylvania, United States, 17101

PHILADELPHIA, Pennsylvania, United States, 19102-1192

PHILADELPHIA, Pennsylvania, United States, 19140
United States, Rhode Island

PROVIDENCE, Rhode Island, United States, 02903
United States, Texas

DALLAS, Texas, United States, 75246

SAN ANTONIO, Texas, United States, 78284
United States, Utah

SALT LAKE CITY, Utah, United States, 84132
United States, Vermont

BURLINGTON, Vermont, United States, 05401
United States, Virginia

FALLS CHURCH, Virginia, United States, 22042-3300

NORFOLK, Virginia, United States, 23502
United States, Washington

SEATTLE, Washington, United States, 98104
United States, Wisconsin

MADISON, Wisconsin, United States, 53792

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	ML17225
Study First Received:	July 12, 2004
Last Updated:	May 13, 2009
ClinicalTrials.gov Identifier:	NCT00087581 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Anti-Infective Agents
Cyclosporine
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Mycophenolic Acid
Enzyme Inhibitors
Tacrolimus

Antibiotics, Antineoplastic
Cyclosporins
Immunosuppressive Agents
Pharmacologic Actions
Therapeutic Uses
Antifungal Agents
Mycophenolate mofetil
Antirheumatic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on November 30, 2009