The Folic Acid for Vascular Outcome Reduction in Transplantation (FAVORIT)

• Study Description
• Centers
• FAVORIT Website
• Study Inventory
• Recruiting patients: see www.clinicaltrials.gov (Key Word: 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