BACKGROUND:Patients with chronic kidney disease, including kidney transplant recipients, are at high risk for cardiovascular disease (CVD). In addition to the constellation of traditional CVD risk factors in chronic kidney disease, elevated total homocysteine (tHcy) is notably more prevalent among the general population. The Folic Acid for Vascular Outcome Reduction In Transplantation (FAVORIT) trial is designed to evaluate whether lowering tHcy using vitamin supplementation reduces CVD events in renal transplant recipients. METHODS: FAVORIT is a multicenter double-blind randomized controlled clinical trial. Participants are clinically stable renal transplant recipients who are 6 months or longer posttransplant with elevated tHcy. Patients are randomized to a multivitamin that includes either a high-dose or low-dose of folic acid (5 or 0 mg), vitamin B6 (50 or 1.4 mg), and vitamin B12 (1000 or 2 microg). The primary end point is a composite of incident or recurrent CVD outcomes, that is, coronary heart, cerebrovascular, or abdominal aortic/lower extremity arterial events. A sample size of 4000 is estimated to provide 87% power to detect a 20% treatment effect. Recruitment is expected to continue until July 2006, with follow-up through June 2010. RESULTS:From August 2002 through December 2004, 2234 of the target4000 patients were enrolled. In accordance with trial design, mean (SD) screening tHcy was elevated (17.4 +/- 6.2 micromol/L), and mean (SD) estimated creatinine clearance was consistent with stable renal function (58.0 +/- 18.6 mL/min). Evaluating baseline results to date, 42% of the randomized participants had a history of diabetes mellitus, and 21% had prevalent CVD. CONCLUSIONS: The FAVORIT trial is designed with sufficient power and follow-up time to detect a clinically relevant change in CVD risk between renal transplant recipients receiving a high or low tHcy-lowering folic acid multivitamin. Preliminary screening and baseline data support the trial's objectives.
RCT Entities:
BACKGROUND:Patients with chronic kidney disease, including kidney transplant recipients, are at high risk for cardiovascular disease (CVD). In addition to the constellation of traditional CVD risk factors in chronic kidney disease, elevated total homocysteine (tHcy) is notably more prevalent among the general population. The Folic Acid for Vascular Outcome Reduction In Transplantation (FAVORIT) trial is designed to evaluate whether lowering tHcy using vitamin supplementation reduces CVD events in renal transplant recipients. METHODS: FAVORIT is a multicenter double-blind randomized controlled clinical trial. Participants are clinically stable renal transplant recipients who are 6 months or longer posttransplant with elevated tHcy. Patients are randomized to a multivitamin that includes either a high-dose or low-dose of folic acid (5 or 0 mg), vitamin B6 (50 or 1.4 mg), and vitamin B12 (1000 or 2 microg). The primary end point is a composite of incident or recurrent CVD outcomes, that is, coronary heart, cerebrovascular, or abdominal aortic/lower extremity arterial events. A sample size of 4000 is estimated to provide 87% power to detect a 20% treatment effect. Recruitment is expected to continue until July 2006, with follow-up through June 2010. RESULTS: From August 2002 through December 2004, 2234 of the target 4000 patients were enrolled. In accordance with trial design, mean (SD) screening tHcy was elevated (17.4 +/- 6.2 micromol/L), and mean (SD) estimated creatinine clearance was consistent with stable renal function (58.0 +/- 18.6 mL/min). Evaluating baseline results to date, 42% of the randomized participants had a history of diabetes mellitus, and 21% had prevalent CVD. CONCLUSIONS: The FAVORIT trial is designed with sufficient power and follow-up time to detect a clinically relevant change in CVD risk between renal transplant recipients receiving a high or low tHcy-lowering folic acid multivitamin. Preliminary screening and baseline data support the trial's objectives.
Authors: Myra A Carpenter; Matthew R Weir; Deborah B Adey; Andrew A House; Andrew G Bostom; John W Kusek Journal: Clin Transplant Date: 2012-07-09 Impact factor: 2.863
Authors: D E Weiner; M A Carpenter; A S Levey; A Ivanova; E H Cole; L Hunsicker; B L Kasiske; S J Kim; J W Kusek; A G Bostom Journal: Am J Transplant Date: 2012-05-17 Impact factor: 8.086
Authors: Augustine W Kang; Carol Ewing Garber; Charles B Eaton; Patricia M Risica; Andrew G Bostom Journal: Med Sci Sports Exerc Date: 2019-06 Impact factor: 5.411
Authors: Petr Jarolim; Brian L Claggett; Michael J Conrad; Myra A Carpenter; Anastasia Ivanova; Andrew G Bostom; John W Kusek; Lawrence G Hunsicker; Paul F Jacques; Lisa Gravens-Mueller; Peter Finn; Scott D Solomon; Daniel E Weiner; Andrew S Levey; Marc A Pfeffer Journal: Transplantation Date: 2017-01 Impact factor: 4.939
Authors: Rakesh Malhotra; Ronit Katz; Daniel E Weiner; Andrew S Levey; Alfred K Cheung; Andrew G Bostom; Joachim H Ix Journal: Am J Hypertens Date: 2019-08-14 Impact factor: 2.689
Authors: Andrew G Bostom; Myra A Carpenter; John W Kusek; Andrew S Levey; Lawrence Hunsicker; Marc A Pfeffer; Jacob Selhub; Paul F Jacques; Edward Cole; Lisa Gravens-Mueller; Andrew A House; Clifton Kew; Joyce L McKenney; Alvaro Pacheco-Silva; Todd Pesavento; John Pirsch; Stephen Smith; Scott Solomon; Matthew Weir Journal: Circulation Date: 2011-04-11 Impact factor: 29.690
Authors: Daniel E Weiner; Meyeon Park; Hocine Tighiouart; Alin A Joseph; Myra A Carpenter; Nitender Goyal; Andrew A House; Chi-Yuan Hsu; Joachim H Ix; Paul F Jacques; Clifton E Kew; S Joseph Kim; John W Kusek; Todd E Pesavento; Marc A Pfeffer; Stephen R Smith; Matthew R Weir; Andrew S Levey; Andrew G Bostom Journal: Am J Kidney Dis Date: 2018-07-20 Impact factor: 8.860