Phase 3 N=4,110 Randomized Quadruple-blind Treatment

Folic Acid for Vascular Outcome Reduction In Transplantation (FAVORIT)

Chronic Kidney Disease · Cardiovascular Disease · Death

Bottom Line

View on ClinicalTrials.gov: NCT00064753 ↗

Enrolled (actual)

4,110

Serious AEs

0.0%

Results posted

Nov 2015

Primary outcome: 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 — 269; 278 participants — p=0.93

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: High Dose Multivitamin (Drug); Low Dose Multivitamin (Device)
Age: Adult, Older Adult · 35+ yrs
Sex: All
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Primary completion: Oct 2011

Outcome Measures

Outcome	Result	p-value
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	269; 278	0.93
SECONDARY Renal Graft Failure	181; 162	0.19
SECONDARY Mortality (All-cause)	217; 214	0.67
SECONDARY Fatal/Non-fatal Myocardial Infarction (MI)	90; 86	0.61
SECONDARY Fatal/Non-fatal Stroke	35; 32	0.64
SECONDARY Resuscitated Sudden Death (RSD)	7; 9	0.66
SECONDARY CVD Death	75; 91	0.28
SECONDARY Coronary Artery Revascularization	111; 120	0.70
SECONDARY Lower Extremity Peripheral Arterial Disease (PAD)	59; 53	0.49
SECONDARY Carotid Endarterectomy or Angioplasty	10; 9	0.78
SECONDARY Abdominal Aortic Aneurysm Repair	3; 5	0.50
SECONDARY Renal Artery Revascularization	9; 7	0.60

Summary

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00064753). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.