The purpose of this study is to compare the safety and efficacy of Prograf/MMF, Neoral/MMF and Modified Release (MR) Tacrolimus/MMF in de novo kidney transplant recipients.

Condition	Treatment or Intervention	Phase
Kidney Transplantation	Drug: Modified Release (MR) Tacrolimus	Phase III

Further Study Details: 

Expected Total Enrollment:  660

This will be a randomized, open-label, comparative, multi-center study in de novo kidney transplant recipients. Enrollment will include approximately 660 patients at 60-70 centers in the U.S., Canada and South America.

Ages Eligible for Study:  12 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

• Recipient of a primary or retransplanted non-HLA-identical living or non-HLA-identical cadaveric kidney transplant
• Age greater or equal to 12 years

Exclusion Criteria

• Recipient or donor is known seropositive for human immunodeficiency virus (HIV)
• Has current malignancy or history of malignancy
• Has significant liver disease
• Has uncontrolled concomitant infection or any other unstable medical condition
• Is receiving everolimus or enteric coated mycophenolic acid at any time during the study
• Received kidney with a cold ischemia time of equal or more than 36 hours
• Received kidney transplant from a cadaveric donor equal or more than 60 years of age
• Received IVIG therapy prior to randomization

Alabama
      Birmingham,  Alabama,  35294,  United States
      Mobile,  Alabama,  36617,  United States
California
      Los Angeles,  California,  90095-7306,  United States
      Los Angeles,  California,  90057,  United States
      Los Angeles,  California,  90048,  United States
      Sacramento,  California,  95817,  United States
      San Diego,  California,  92123,  United States
      San Diego,  California,  92103-8401,  United States
      Loma Linda,  California,  92354,  United States
      Los Angeles,  California,  90033,  United States
      Los Angeles,  California,  90095-7306,  United States
      San Francisco,  California,  94115,  United States
      Palo Alto,  California,  94304,  United States
      San Francisco,  California,  94143-0780,  United States
Colorado
      Denver,  Colorado,  80262,  United States
District of Columbia
      Washington, DC,  District of Columbia,  20010,  United States
Florida
      Gainesville,  Florida,  32610-0224,  United States
      Jacksonville,  Florida,  32216,  United States
      Orlando,  Florida,  32805,  United States
Georgia
      Augusta,  Georgia,  30912,  United States
Hawaii
      Honolulu,  Hawaii,  96813,  United States
Illinois
      Chicago,  Illinois,  60637,  United States
      Chicago,  Illinois,  60612,  United States
      Chicago,  Illinois,  60612,  United States
Indiana
      Indianapolis,  Indiana,  46202,  United States
      Indianapolis,  Indiana,  46202,  United States
Iowa
      Iowa City,  Iowa,  52242-1086,  United States
Kentucky
      Lexington,  Kentucky,  40536,  United States
Louisiana
      New Orleans,  Louisiana,  70121,  United States
      New Orleans,  Louisiana,  70112,  United States
Maine
      Portland,  Maine,  04102,  United States
Maryland
      Baltimore,  Maryland,  21287,  United States
      Baltimore,  Maryland,  21201,  United States
Massachusetts
      Boston,  Massachusetts,  02114,  United States
Michigan
      Ann Arbor,  Michigan,  48109-0364,  United States
      Detroit,  Michigan,  48202,  United States
New Jersey
      Livingston,  New Jersey,  07039,  United States
      New Brunswick,  New Jersey,  08903,  United States
New York
      New York,  New York,  10019,  United States
      Bronx,  New York,  10467,  United States
      Albany,  New York,  12208,  United States
      Hawthorne,  New York,  10532,  United States
      Buffalo,  New York,  14203,  United States
North Carolina
      Durham,  North Carolina,  27710,  United States
      Chapel Hill,  North Carolina,  27599,  United States
Ohio
      Cincinnati,  Ohio,  45267-0585,  United States
      Cincinnati,  Ohio,  45269-0558,  United States
Oregon
      Portland,  Oregon,  97239-2940,  United States
      Portland,  Oregon,  97210,  United States
Pennsylvania
      Philadelphia,  Pennsylvania,  19104,  United States
      Hershey,  Pennsylvania,  17033-0850,  United States
      Philadelphia,  Pennsylvania,  19107,  United States
      Philadelphia,  Pennsylvania,  19102,  United States
      Philadelphia,  Pennsylvania,  19141,  United States
      Harrisburg,  Pennsylvania,  17104,  United States
Tennessee
      Nashville,  Tennessee,  37232-4750,  United States
Texas
      Dallas,  Texas,  75246,  United States
      Houston,  Texas,  77030,  United States
      San Antonio,  Texas,  78229-3900,  United States
      Dallas,  Texas,  75235,  United States
Utah
      Salt Lake City,  Utah,  84132,  United States
Virginia
      Fairfax,  Virginia,  22041,  United States
Washington
      Seattle,  Washington,  98195,  United States
Wisconsin
      Madison,  Wisconsin,  53792-7375,  United States
      Milwaukee,  Wisconsin,  53226,  United States
Brazil
      Rio de Janeiro,  21041-003,  Brazil
      Campinas,  13083-971,  Brazil
      Sao Paulo,  04038-002,  Brazil
      Porto Alegre,  90850-250,  Brazil
      Sao Paulo,  05465-040,  Brazil
Canada, Alberta
      Edmonton,  Alberta,  T6G 2B7,  Canada
      Calgary,  Alberta,  T2N 2T9,  Canada
Canada, British Columbia
      Vancouver,  British Columbia,  V5Z 3X7,  Canada
Canada, Nova Scotia
      Halifax,  Nova Scotia,  B3H 1Y6,  Canada
Canada, Ontario
      Toronto,  Ontario,  M5C 2T2,  Canada

Study ID Numbers:  02-0-158
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  July 10, 2003
ClinicalTrials.gov Identifier:  NCT00064701
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08