The purpose of this randomized clinical trial is to determine if lowering homocysteine levels in renal transplant recipients with a multivitamin will reduce the occurrence of cardiovascular disease outcomes.

Condition	Treatment or Intervention	Phase
Renal transplant recipients	Drug: multi-vitamin	Phase II Phase III

The hypothesis of the trial is as follows: Treatment with a high dose combination of folic acid, vitamin B6, and vitamin B12 will reduce the rate of pooled arteriosclerotic cardiovascular disease outcomes (i.e., pooled occurrence of non-fatal and fatal arteriosclerotic outcomes, including coronary heart, cerebrovascular, and peripheral vascular disease events) relative to treatment with an identical multivitamin containing no folic acid, and Estimated Average Requirement amounts of vitamin B6, vitamin B12, among chronic, stable renal transplant recipients

Ages Eligible for Study:  35 Years   -   75 Years,  Genders Eligible for Study:  Both

Criteria

• Age 35 to 75
• chronic renal transplant recipient (graft functioning for at least 6 months)
• Cockcroft-Gault serum creatinine based estimate of glomerular filtration rate equal to or greater than 30 ml/min
• non-fasting plasma homocysteine in men of 12 or greater micromole/liter, in women greater than or equal to 11 micromole per liter

Joyce L McKenney, MA, MPH      401-444-4833    jmckenney@lifespan.org

Alabama
      University of Alabama at Birmingham School of Medicine, Birmingham,  Alabama,  35233,  United States; Recruiting
California
      University of California at San Francisco, San Francisco,  California,  94143-0780,  United States; Recruiting
      University of California at Los Angeles, Los Angeles,  California,  United States; Recruiting
      Cedars-Sinai Health System/Center for Kidney Diseases and Transplantation, Los Angeles,  California,  90048,  United States; Recruiting
Indiana
      Indiana University, Indianapolis,  Indiana,  46202,  United States; Recruiting
Iowa
      University of Iowa Hospitals and Clinics, Iowa City,  Iowa,  52242,  United States; Recruiting
Maryland
      University of Maryland Medical Center, Baltimore,  Maryland,  21201,  United States; Recruiting
Michigan
      University of Michigan Medical Center, Ann Arbor,  Michigan,  48109-0364,  United States; Recruiting
Minnesota
      Hennepin County Medical Center, Minneapolis,  Minnesota,  55404,  United States; Recruiting
Missouri
      Washington University, St. Louis,  Missouri,  63110,  United States; Recruiting
New York
      Albany Medical Center, Albany,  New York,  12208,  United States; Recruiting
      State University of New York Downstate Medical Center, Brooklyn,  New York,  11203,  United States; Recruiting
North Carolina
      Duke University Medical Center, Durham,  North Carolina,  27710,  United States; Recruiting
Ohio
      The Ohio State University Medical Center, Columbus,  Ohio,  43210-1228,  United States; Recruiting
Oregon
      Oregon Health Sciences University, Portland,  Oregon,  97201-2940,  United States; Recruiting
Rhode Island
      Rhode Island Hospital, Providence,  Rhode Island,  02903,  United States; Recruiting
      Rhode Island Hospital/Lifespan, Providence,  Rhode Island,  02903,  United States; Recruiting
Wisconsin
      Medical College of Wisconsin, Milwaukee,  Wisconsin,  53226,  United States; Recruiting
      University of Wisconsin at Madison, Madison,  Wisconsin,  53792-1735,  United States; Recruiting
Canada, Ontario
      London Health Sciences Center, London,  Ontario,  N6A5A5,  Canada; Recruiting
      Toronto General Hospital, Toronto,  Ontario,  Canada; Recruiting

Study chairs or principal investigators

Andrew Bostom, M.D.,  Study Director,  abostom@lifespan.org   

Study ID Numbers:  FAVORIT
Record last reviewed:  July 2004
Record first received:  July 11, 2003
ClinicalTrials.gov Identifier:  NCT00064753
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-08