Folic Acid for Vascular Outcome Reduction In Transplantation (FAVORIT)



Status:Completed
Conditions:Peripheral Vascular Disease, Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Cardiology / Vascular Diseases, Nephrology / Urology
Healthy:No
Age Range:35 - 75
Updated:10/20/2017
Start Date:May 2002
End Date:October 2011

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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.

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

Inclusion Criteria:

- 35 - 75 years old

- Had kidney transplant at least 6 months

- Calculated Creatinine Clearance must be 25 mL/min or greater

- Must be willing to stop supplements (B6, B12, folic acid) for 4-6 weeks prior to visit

Exclusion Criteria:

- If pregnant or lactating

- If of child bearing potential and not on birth control

- If any of the following will limit life expectancy to less than 2 yrs:

- Cancer

- Congestive heart failure (CHF) (end stage)

- Liver disease (end stage)

- Severe pulmonary disease

- Progressive HIV

- Any other chronic wasting illness

- If patient had myocardial infarction (MI), stroke, lower extremity amputation above
ankle or percutaneous revascularization procedure (coronary, cerebrovascular, lower
extremity) in past 2months

- If patient had coronary artery bypass graft (CABG) or abdominal aortic aneurysm (AAA)
in past 5 months

- If patient has conditions that prevent reliable study participation e.g., depression,
alcohol or drug abuse, other cardiovascular disease (CVD) studies

- If patient has had multi-organ transplant, except kidney/pancreas
We found this trial at
28
sites
Madison, Wisconsin 53706
(608) 263-2400
University of Wisconsin-Madison In achievement and prestige, the University of Wisconsin-Madison has long been recognized...
1654
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Madison, WI
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
2578
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Boston, MA
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
1791
mi
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Indianapolis, IN
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Los Angeles, California 90095
310-825-4321
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
25
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Los Angeles, CA
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22 Bramhall St
Portland, Maine 04102
(207) 662-0111
Maine Medical Center One of the country's consistently highest rated hospitals is right in your...
2614
mi
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Portland, ME
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
2562
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Providence, RI
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Albany, New York 12208
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Albany, NY
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Ann Arbor, Michigan 48109
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Ann Arbor, MI
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22 S Greene St
Baltimore, Maryland 21201
(410) 328-8667
University of Maryland Medical Center Founded in 1823 as the Baltimore Infirmary, the University of...
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mi
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Baltimore, MD
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Birmingham, AL
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Brooklyn, NY
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303 East Superior Street
Chicago, Illinois 60611
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Chicago, IL
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1959
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Columbus, OH
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
2203
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Durham, NC
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1001 E 5th St
Greenville, North Carolina 27858
(252) 328-6131
East Carolina University Whether it's meeting the demand for more teachers and healthcare professionals or...
2290
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Greenville, NC
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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Iowa City, IA
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20
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Los Angeles, CA
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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Milwaukee, WI
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Minneapolis, Minnesota 55414
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Minneapolis, MN
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Minneapolis, Minnesota 55455
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Minneapolis, MN
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3301 Lancaster Avenue
Philadelphia, Pennsylvania 19102
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Philadelphia, PA
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Phoenix, Arizona 85004
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Phoenix, AZ
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Portland, Oregon 97227
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Portland, OR
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Rochester, Minnesota 55905
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Rochester, MN
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Saint Louis, Missouri 63110
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Saint Louis, MO
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San Francisco, California 94143
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San Francisco, CA
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Sao Paulo, SP 04023
6146
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Sao Paulo,
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327 W Calhoun Ave
Springfield, Illinois 62702
(217) 545-0223
Southern Illinois University From its humble beginnings as the state's second teachers college - founded...
1608
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Springfield, IL
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