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Clinical Trial Details

Trial ID: L0800
Source ID: NCT00064753
Associated Drug: High Dose Multivitamin
Title: Folic Acid for Vascular Outcome Reduction In Transplantation (FAVORIT)
Acronym: FAVORIT
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00064753/results
Conditions: Chronic Kidney Disease|Cardiovascular Disease|Death
Interventions: DRUG: High Dose Multivitamin|DEVICE: Low Dose Multivitamin
Outcome Measures: Primary: Recurrent or de Novo Arteriosclerotic Cardiovascular Disease (CVD) Defined as the Occurrence of Non-fatal or Fatal Arteriosclerotic Outcomes Including Coronary Heart, Cerebrovascular, and Peripheral Vascular Disease Events, Up to 6 years (mean 4 years) | Secondary: Renal Graft Failure, Up to 6 years (mean 4 years)|Mortality (All-cause), censored at 3 months after return to dialysis, Up to 6 years (mean 4 years)|Fatal/Non-fatal Myocardial Infarction (MI), censored at 3 months after return to dialysis, Up to 6 years (mean 4 years)|Fatal/Non-fatal Stroke, censored at 3 months after return to dialysis, Up to 6 years (mean 4 years)|Resuscitated Sudden Death (RSD), censored at 3 months after return to dialysis, Up to 6 years (mean 4 years)|CVD Death, censored at 3 months after return to dialysis, Up to 6 years (mean 4 years)|Coronary Artery Revascularization, censored at 3 months after return to dialysis, Up to 6 years (mean 4 years)|Lower Extremity Peripheral Arterial Disease (PAD), censored at 3 months after return to dialysis, Up to 6 years (mean 4 years)|Carotid Endarterectomy or Angioplasty, censored at 3 months after return to dialysis, Up to 6 years (mean 4 years)|Abdominal Aortic Aneurysm Repair, censored at 3 months after return to dialysis, Up to 6 years (mean 4 years)|Renal Artery Revascularization, censored at 3 months after return to dialysis, Up to 6 years (mean 4 years)
Sponsor/Collaborators: Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Collaborators: Office of Dietary Supplements (ODS)
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2|PHASE3
Enrollment: 4110
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2002-05
Completion Date: 2011-10
Results First Posted: 2015-11-26
Last Update Posted: 2017-10-18
Locations: University of Alabama at Birmingham School of Medicine, Birmingham, Alabama, 35233, United States|Banner Good Samaritan Transplant, Phoenix, Arizona, 85004-1608, United States|Cedars-Sinai Health System/Center for Kidney Diseases and Transplantation, Los Angeles, California, 90048, United States|University of California at Los Angeles, Los Angeles, California, 90095-7306, United States|University of California at San Francisco, San Francisco, California, 94143-0780, United States|Northwestern University, Chicago, Illinois, 60611, United States|Southern Illinois University, Springfield, Illinois, 62794-9638, United States|Indiana University, Indianapolis, Indiana, 46202, United States|University of Iowa Hospitals and Clinics, Iowa City, Iowa, 52242, United States|Maine Medical Center, Portland, Maine, 04102, United States|University of Maryland Medical Center, Baltimore, Maryland, 21201, United States|Brigham and Women's Hospital, Boston, Massachusetts, 02120, United States|University of Michigan Medical Center, Ann Arbor, Michigan, 48109-0364, United States|Hennepin County Medical Center, Minneapolis, Minnesota, 55404, United States|Faireview University Medical Center, Minneapolis, Minnesota, 55455, United States|Mayo Clinic, Rochester, Minnesota, 55905, United States|Washington University, Saint Louis, Missouri, 63110, United States|Albany Medical Center, Albany, New York, 12208, United States|State University of New York Downstate Medical Center, Brooklyn, New York, 11203, United States|Duke University Medical Center, Durham, North Carolina, 27710, United States|East Carolina University, Greenville, North Carolina, 27834, United States|The Ohio State University Medical Center, Columbus, Ohio, 43210-1228, United States|Oregon Health Sciences University, Portland, Oregon, 97201-2940, United States|Drexel University, Philadelphia, Pennsylvania, 19102-1192, United States|Rhode Island Hospital, Providence, Rhode Island, 02903, United States|University of Wisconsin at Madison, Madison, Wisconsin, 53792, United States|Medical College of Wisconsin, Milwaukee, Wisconsin, 53226, United States|Universidade Federal de Sao Paulo, Sao Paulo, SP, 04023-900, Brazil|London Health Sciences Center, London, Ontario, N6A 5A5, Canada|Toronto General Hospital, Toronto, Ontario, M5G 2N2, Canada
URL: https://clinicaltrials.gov/show/NCT00064753