Baseline characteristics of participants in the Folic Acid for Vascular Outcome Reduction in Transplantation (FAVORIT) Trial.
BACKGROUND
Hyperhomocysteinemia may be a modifiable risk factor for the prevention of arteriosclerotic outcomes in patients with chronic kidney disease (CKD). Few clinical trials of homocysteine lowering have been conducted in persons with CKD before reaching end-stage renal disease. Kidney transplant recipients are considered individuals with CKD.


OBJECTIVE
To describe the baseline characteristics of renal transplant recipients enrolled in a clinical trial of homocysteine lowering with a standard multivitamin containing high doses of folic acid and vitamins B(6) and B(12) aimed at reducing arteriosclerotic outcomes. Factors considered were level of kidney function, total homocysteine concentration, and prevalence of diabetes and previous cardiovascular disease (CVD).


METHODS
Cross-sectional survey within a randomized controlled trial cohort.


METHODS
Participants were recruited from kidney transplant clinics in the United States, Canada, and Brazil. Eligible participants had increased levels of homocysteine (> or =12.0 micromol/L in men and > or =11.0 micromol/L in women) and kidney function measured by means of Cockroft-Gault estimated creatinine clearance of 30 mL/min or greater.


RESULTS
Of 4,110 randomly assigned participants, 38.9% had diabetes and 19.5% had previous CVD. Mean total homocysteine concentration was 17.1 +/- 6.3 (SD) micromol/L, whereas mean creatinine clearance was 66.4 +/- 23.2 mL/min. Approximately 90% of the trial cohort had an estimated glomerular filtration rate consistent with stages 2 to 3 CKD (i.e., 30 to 89 mL/min).


CONCLUSIONS
Analysis is based on cross-sectional data from a randomized controlled trial, self-report of comorbid illnesses, and level of kidney function was estimated.


CONCLUSIONS
A large population of stable renal transplant recipients who are at high risk of the development of CVD (both de novo and recurrent) has been recruited into the Folic Acid for Vascular Outcome Reduction in Transplantation Trial and are likely to experience a sufficient number of events to address the primary hypothesis of the trial.
Bostom
Andrew G
AG
Rhode Island Hospital, 593 Eddy Street, Providence, RI 02903, USA.
Carpenter
Myra A
MA
Hunsicker
Lawrence
L
Jacques
Paul F
PF
Kusek
John W
JW
Levey
Andrew S
AS
McKenney
Joyce L
JL
Mercier
Renee Y
RY
Pfeffer
Marc A
MA
Selhub
Jacob
J
D000328:Adult; D001938:Brazil; D002170:Canada; D002318:Cardiovascular Diseases / Q000097:blood / Q000209:etiology / Q000517:prevention & control*; D002908:Chronic Disease; D015331:Cohort Studies; D003404:Creatinine / Q000097:blood; D003430:Cross-Sectional Studies; D004305:Dose-Response Relationship, Drug; D005260:Female; D005492:Folic Acid / Q000627:therapeutic use*; D005919:Glomerular Filtration Rate / Q000502:physiology; D006710:Homocysteine / Q000097:blood; D006801:Humans; D007668:Kidney / Q000503:physiopathology; D007674:Kidney Diseases / Q000097:blood / Q000150:complications / Q000601:surgery*; D016030:Kidney Transplantation; D008297:Male; D008875:Middle Aged; D012307:Risk Factors; D016896:Treatment Outcome; D014481:United States; D014803:Vitamin B Complex / Q000627:therapeutic use*
D006710:Homocysteine; D014803:Vitamin B Complex; D005492:Folic Acid; D003404:Creatinine