This study will compare the effects on kidney function of CellCept (drug to prevent organ rejection) along with a calcineurin inhibitor (another drug to prevent organ rejection) in 3 different dosing regimens. This study will also look at the safety and effectiveness of using therapeutic drug monitoring (TDM) of CellCept to determine the dose of drug (amount to be given) compared to a fixed (unchanging) dose. Therapeutic drug monitoring measures the amount of drug in the blood and requires a blood sample be drawn. The amount of drug given will be adjusted (increased, decreased or unchanged) based on the blood test results. Patients will be randomly assigned one of three groups: Group A: CellCept dose will be adjusted based on blood test result (therapeutic drug monitoring) along with reduced (less than usual) dose of calcineurin inhibitor Group B: CellCept dose will be adjusted based on blood test result (therapeutic drug monitoring) along with standard (usual) dose of calcineurin inhibitor Group C: CellCept dose will be standard (usual) along with standard (usual) dose of calcineurin inhibitor. Participants will be required to make 10 study visits over a 24 month period

Condition	Treatment or Intervention	Phase
renal transplant	Drug: mycophenolate mofetil	Phase IV

Ages Eligible for Study:  13 Years   -   75 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Male or female between 13-75 years old.
• Patient receiving one organ transplant, kidney only.
• Patient receiving a first or second kidney transplant.
• Patient receiving a kidney from living a donor (related or unrelated).
• Patient receiving kidney from a deceased heart-beating donor.
• Patient able to receive the study medication CellCept within 24 hours of transplant.
• Patient willing and able to provide a written informed consent
• Patients willing and able to stay the course of therapy required by the study and complete all the assessments.
• Patients able to take the medications required in the study.
• Females capable of becoming pregnant: 1) Must not be pregnant, this must be confirmed by a negative pregnancy test within one week before starting CellCept. 2) Must agree to use an effective birth control method before beginning treatment, during treatment and for 6 weeks after stopping treatment, even if there is a history of infertility.

Exclusion Criteria:

• Females who are pregnant.
• Females who are breast-feeding.
• Patients with evidence of chronic active hepatitis B infection.
• Patients with evidence of chronic active hepatitis C infection.
• Patients with gastrointestinal disorders that may interfere with absorption of drugs used in the study.
• Patients needing antacids containing magnesium or aluminum after transplant or needing drugs known as bile acid sequestrants (drugs that bind bile acid to help lower cholesterol).
• Patient with an active infection requiring continued use of antibiotics.
• Patients with HIV infection.
• Patients with a PRA (Panel Reactive Antibody-a blood test) greater than 50% within 6 months prior to enrollment.
• Patients receiving medications to suppress the immune system within 28 days before 1st transplant and within 3 months before 2nd transplant. (Drugs given 48 hours before transplant and treatment with corticosteroids are permitted).
• Females capable of becoming pregnant who are not willing to use a reliable form of birth control.
• Patients with history of cancer in the last five years, except for successfully treated skin cancer (not melanoma).
• Patients allergic to any of the drugs to be given during the study or to any ingredients in those drugs (mycophenolate mofetil, cyclosporine, tacrolimus, corticosteroids).
• Blood type not compatible with donor.
• Patients with any form of substance abuse or with psychiatric disorder or condition, which in the opinion of the investigator, may interfere with patient's ability to meet study requirements.
• Patients with severe anemia.
• Patients receiving experimental drugs for prevention or treatment of acute rejection.

Please reference Study ID Number: RLI-ML17225      973-235-5000 
or      800-526-6367 (FOR US ONLY) 

Alabama
      Birmingham,  Alabama,  35294,  United States; Recruiting
Arkansas
      Little Rock,  Arkansas,  72205,  United States; Recruiting
California
      San Francisco,  California,  94143,  United States; Recruiting
      Los Angeles,  California,  90057,  United States; Recruiting
      San Diego,  California,  92103,  United States; Not yet recruiting
      Los Angeles,  California,  90048,  United States; Not yet recruiting
Colorado
      Denver,  Colorado,  80262,  United States; Not yet recruiting
Florida
      Miami,  Florida,  33101,  United States; Not yet recruiting
      Gainesville,  Florida,  32610,  United States; Recruiting
      Orlando,  Florida,  32804,  United States; Recruiting
      Jacksonville,  Florida,  32216,  United States; Not yet recruiting
      Tampa,  Florida,  33606,  United States; Not yet recruiting
Georgia
      Augusta,  Georgia,  30912,  United States; Recruiting
Indiana
      Indianapolis,  Indiana,  46202,  United States; Recruiting
Kansas
      Wichita,  Kansas,  67214,  United States; Recruiting
Kentucky
      Lexington,  Kentucky,  40536,  United States; Not yet recruiting
Louisiana
      New Orleans,  Louisiana,  70121,  United States; Not yet recruiting
Maryland
      Baltimore,  Maryland,  21287,  United States; Not yet recruiting
Massachusetts
      Boston,  Massachusetts,  02111,  United States; No longer recruiting
      Boston,  Massachusetts,  02111,  United States; Recruiting
      Worcester,  Massachusetts,  01655,  United States; Recruiting
      Boston,  Massachusetts,  02215,  United States; Not yet recruiting
      Springfield,  Massachusetts,  01107,  United States; Recruiting
      Burlington,  Massachusetts,  01805,  United States; Not yet recruiting
Michigan
      Ann Arbor,  Michigan,  48109,  United States; Recruiting
      Detroit,  Michigan,  48202,  United States; Not yet recruiting
Minnesota
      Rochester,  Minnesota,  55905,  United States; Not yet recruiting
New Jersey
      Livingston,  New Jersey,  07039,  United States; Recruiting
      Hackensack,  New Jersey,  07601,  United States; Recruiting
New York
      New York,  New York,  10029,  United States; Recruiting
      Bronx,  New York,  10467,  United States; Not yet recruiting
      New York,  New York,  10021,  United States; Not yet recruiting
      Hawthorne,  New York,  10532,  United States; Recruiting
      Buffalo,  New York,  14203,  United States; Not yet recruiting
North Carolina
      Chapel Hill,  North Carolina,  27599,  United States; Not yet recruiting
      Winston Salem,  North Carolina,  27157,  United States; Not yet recruiting
North Dakota
      Fargo,  North Dakota,  58122,  United States; Not yet recruiting
Ohio
      Cleveland,  Ohio,  44106,  United States; Recruiting
Oregon
      Portland,  Oregon,  97232,  United States; Recruiting
Pennsylvania
      Philadelphia,  Pennsylvania,  19104,  United States; Not yet recruiting
      Harrisburg,  Pennsylvania,  17108,  United States; Recruiting
      Hershey,  Pennsylvania,  17033,  United States; Not yet recruiting
      Philadelphia,  Pennsylvania,  19102,  United States; Recruiting
      Pittsburgh,  Pennsylvania,  15212,  United States; Not yet recruiting
      Philadelphia,  Pennsylvania,  19140,  United States; Not yet recruiting
Rhode Island
      Providence,  Rhode Island,  02903,  United States; Recruiting
Texas
      Dallas,  Texas,  75204,  United States; Recruiting
      Dallas,  Texas,  75204,  United States; Recruiting
      San Antonio,  Texas,  78229,  United States; No longer recruiting
      San Antonio,  Texas,  78229,  United States; Recruiting
Vermont
      Burlington,  Vermont,  05401,  United States; Recruiting
Virginia
      Falls Church,  Virginia,  22042,  United States; Recruiting
      Norfolk,  Virginia,  23502,  United States; Not yet recruiting
Washington
      Seattle,  Washington,  98122,  United States; Recruiting
Wisconsin
      Madison,  Wisconsin,  53792,  United States; Recruiting

Study ID Numbers:  ML17225
Record last reviewed:  April 2005
Last Updated:  April 6, 2005
Record first received:  July 12, 2004
ClinicalTrials.gov Identifier:  NCT00087581
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08