Folic Acid for Vascular Outcome Reduction In Transplantation (FAVORIT)

National Institutes of Health (NIH)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Chronic Kidney Disease; Death; Cardiovascular Disease

Treatments: Drug: High Dose Multivitamin; Device: Low Dose Multivitamin

Study type: Interventional

Funder types: NIH

Identifiers

NCT00064753

U01DK061700 (U.S. NIH Grant/Contract)

FAVORIT dk61700 IND

Details and patient eligibility

About

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.

Full description

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

Enrollment: 4,110 patients

Sex: All

Ages: 35 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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4,110 participants in 2 patient groups

High Dose Multivitamin

Experimental group

Description:

Multivitamin with increased folic acid, vitamin B6 and vitamin B12

Treatment:

Drug: High Dose Multivitamin

Low Dose Multivitamin

Active Comparator group

Description:

Multivitamin devoid of folic acid and with estimated average requirement amounts of vitamin B6 and vitamin B12

Treatment:

Device: Low Dose Multivitamin