Folic Acid for Vascular Outcome Reduction In Transplantation (FAVORIT)

Completed · Phase 2/Phase 3

Conditions studied: Chronic Kidney Disease, Cardiovascular Disease, Death

In brief

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.

Key facts

Study ID

NCT00064753

Run by

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

People needed

4110

Starts

2002-05-01

Expected to finish

2011-10-01

Last updated by the study team

2017-10-18

Who can join

Age: 35 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham School of Medicine — Birmingham, Alabama, United States
• Banner Good Samaritan Transplant — Phoenix, Arizona, United States
• Cedars-Sinai Health System/Center for Kidney Diseases and Transplantation — Los Angeles, California, United States
• University of California at Los Angeles — Los Angeles, California, United States
• University of California at San Francisco — San Francisco, California, United States
• Northwestern University — Chicago, Illinois, United States
• Southern Illinois University — Springfield, Illinois, United States
• Indiana University — Indianapolis, Indiana, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• Maine Medical Center — Portland, Maine, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• University of Michigan Medical Center — Ann Arbor, Michigan, United States
• Hennepin County Medical Center — Minneapolis, Minnesota, United States
• Faireview University Medical Center — Minneapolis, Minnesota, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Washington University — St Louis, Missouri, United States
• Albany Medical Center — Albany, New York, United States
• State University of New York Downstate Medical Center — Brooklyn, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• East Carolina University — Greenville, North Carolina, United States
• The Ohio State University Medical Center — Columbus, Ohio, United States
• Oregon Health Sciences University — Portland, Oregon, United States
• Drexel University — Philadelphia, Pennsylvania, United States
• Rhode Island Hospital — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.