The Folic Acid for Vascular Outcome Reduction in Transplantation (FAVORIT)
Study Description
Patients with chronic renal disease are at high risk for cardiovascular disease.
Some of this elevated risk is due to a higher prevalence of established arteriosclerotic
risk factors such as advanced age, hypertension, dyslipidemia, diabetes, and physical
inactivity, but unique renal insufficiency/uremia-related risk factors may also
exist. Prominent among these risk factors are elevated levels of homocysteine.
The Folic Acid for Vascular Outcome Reduction in Transplantation project, which
began in August 2001 and will end January 31, 2006, is conducting a nationwide,
multicenter clinical trial that will determine whether total homocysteine-lowering
treatment with a high-dose combination of folic acid, vitamin B12, and vitamin B6
will reduce the rate of cardiovascular disease outcomes among stable renal transplant
recipients with mild to moderately elevated total homocysteine levels.
For several reasons, renal transplant recipients are a unique subpopulation for
testing the study's hypothesis. They exhibit a high rate of new and recurrent cardiovascular
disease outcomes. They display an excess prevalence of hyperhomocysteinemia despite
the nationwide fortification of cereal grain flour that is credited with reducing
homocysteine levels in the general population. And, their total homocysteine levels
can be safely and successfully normalized with folic acid and vitamins B12 and B6.
These overall conditions are representative of the population of people in the United
States with chronic renal insufficiency (serum creatinine of 1.5 mg/dL or higher)
who have not yet reached end-stage renal disease.
Recruitment for FAVORIT (www.clinicaltrials.gov) began in July 2002. Over two years,
the study will recruit a total of 4,000 renal transplant recipients. Participants
will be randomized to either a multivitamin that contains high doses of folic acid
and vitamins B6 and B12 or a multivitamin that contains no folic acid and the estimated
average daily requirements of vitamins B6 and B12. The primary outcome of the trial
is recurrent or de novo arteriosclerotic cardiovascular disease, defined as nonfatal
or fatal coronary heart, cerebrovascular, and peripheral vascular disease events:
myocardial infarction, resuscitated sudden death, coronary artery revascularization,
stroke, and peripheral or renovascular disease that requires an invasive procedure
such as angioplasty, stenting, endarterectomy, aneurysm repair, or lower extremity
amputation for an arteriosclerotic complication.
Centers
The double-masked study will be conducted under a cooperative agreement at 20 major
renal transplant centers in the United States and Canada. Participating institutions
are Rhode Island Hospital; University of Iowa; Albany Medical Center; Cedars Sinai
Health System; Duke University Medical Center; Hennepin County Medical Center; Indiana
University; London (Ontario, Canada) Health Sciences Center; Medical College of
Wisconsin; Ohio State University; Oregon Health Sciences University; SUNY Downstate
Medical Center; University of Alabama at Birmingham; University of California at
Los Angeles; University of California at San Francisco; University of Maryland Medical
Center; University of Michigan Medical Center; University of Toronto; University
of Wisconsin; and Washington University. The data-coordinating center is at the
University of North Carolina.
NIDDK Program Director: Dr. John W. Kusek, 301-594-7717
Last Update: 4/13/2004
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