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Folic Acid for Vascular Outcome Reduction In Transplantation (FAVORIT) (FAVORIT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00064753
First Posted: July 15, 2003
Last Update Posted: October 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Office of Dietary Supplements (ODS)
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
July 11, 2003
July 15, 2003
October 26, 2015
November 26, 2015
October 18, 2017
May 2002
October 2011   (Final data collection date for primary outcome measure)
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 [ Time Frame: Up to 6 years (mean 4 years) ]
Not Provided
Complete list of historical versions of study NCT00064753 on ClinicalTrials.gov Archive Site
  • Renal Graft Failure [ Time Frame: Up to 6 years (mean 4 years) ]
  • Mortality (All-cause) [ Time Frame: Up to 6 years (mean 4 years) ]
    censored at 3 months after return to dialysis
  • Fatal/Non-fatal Myocardial Infarction (MI) [ Time Frame: Up to 6 years (mean 4 years) ]
    censored at 3 months after return to dialysis
  • Fatal/Non-fatal Stroke [ Time Frame: Up to 6 years (mean 4 years) ]
    censored at 3 months after return to dialysis
  • Resuscitated Sudden Death (RSD) [ Time Frame: Up to 6 years (mean 4 years) ]
    censored at 3 months after return to dialysis
  • CVD Death [ Time Frame: Up to 6 years (mean 4 years) ]
    censored at 3 months after return to dialysis
  • Coronary Artery Revascularization [ Time Frame: Up to 6 years (mean 4 years) ]
    censored at 3 months after return to dialysis
  • Lower Extremity Peripheral Arterial Disease (PAD) [ Time Frame: Up to 6 years (mean 4 years) ]
    censored at 3 months after return to dialysis
  • Carotid Endarterectomy or Angioplasty [ Time Frame: Up to 6 years (mean 4 years) ]
    censored at 3 months after return to dialysis
  • Abdominal Aortic Aneurysm Repair [ Time Frame: Up to 6 years (mean 4 years) ]
    censored at 3 months after return to dialysis
  • Renal Artery Revascularization [ Time Frame: Up to 6 years (mean 4 years) ]
    censored at 3 months after return to dialysis
Not Provided
Not Provided
Not Provided
 
Folic Acid for Vascular Outcome Reduction In Transplantation (FAVORIT)
Folic Acid for Vascular Outcome Reduction In Transplantation (FAVORIT)
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
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Chronic Kidney Disease
  • Cardiovascular Disease
  • Death
  • Drug: High Dose Multivitamin
    Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg
    Other Name: multivitamin
  • Device: Low Dose Multivitamin
    Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg
    Other Name: multivitamin
  • Experimental: High Dose Multivitamin
    Multivitamin with increased folic acid, vitamin B6 and vitamin B12
    Intervention: Drug: High Dose Multivitamin
  • Active Comparator: Low Dose Multivitamin
    Multivitamin devoid of folic acid and with estimated average requirement amounts of vitamin B6 and vitamin B12
    Intervention: Device: Low Dose Multivitamin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4110
October 2011
October 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
35 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Brazil,   Canada,   United States
 
 
NCT00064753
FAVORIT dk61700 IND
U01DK061700 ( U.S. NIH Grant/Contract )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Yes
Plan Description: Individual patient data and samples are available at the NIDDK Central repository
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: December 2013
URL: https://www.niddkrepository.org/studies/favorit/?query=favorit
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Office of Dietary Supplements (ODS)
Study Director: Andrew Levey, M.D. Tufts Medical Center
Principal Investigator: Myra A Carpenter, PhD University of North Carolina, Chapel Hill
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP