The FAVORIT trial has several design features that enhance its ability to address the question of whether lowering total homocysteine (tHcy) concentrations can reduce the risk of CVD among patients with chronic kidney disease (CKD). At the current three month rate of 152 randomizations per month FAVORIT will complete enrollment well within the target deadline of January 31, 2007 The sample size (n=4000;n=3621 recruited as of July 5, 2006) is the largest to date for a trial with our objective, the planned follow-up time through June 2011, is the longest, and preliminary screening data suggest baseline tHcy levels are higher in FAVIORIT than in trials conducted among non-renal disease populations. Assuming the projected FAVORIT event rate for CVD among controls occurs, the trial will remain well-powered (i.e., 0.87) to discern a moderate 20% reduction in events (if achieved) with active tHcy-lowering treatment. The FAVORIT trial provides a unique opportunity to obtain biologic specimens on a large cohort of stable kidney transplant recipients at baseline and annually throughout 4.5 to 9 years of proposed follow-up. Appropriate consent has been obtained to make specimens available for ancillary studies and many of the specimens have already been transferred to the NIDDK Specimen Repository. For use in ancillary studies, the following specimen types are being collected: EDTA plasma, buffy coat, red blood cells, serum, sodium citrate plasma, and urine. These specimens have bar-coded'ID labels without any personal identifiers. Regardless of whether or not the tHcy-lowering intervention in FAVORIT significantly reduces CVD event rates, monitoring the trial cohort of 4000 chronic stable renal transplant recipients, ranging from a minimum follow-up of 4.5 years, to a maximum of 9 years, will provide unique data on arteriosclerotic CVD outcomes, and (potential) antecedent CVD risk factors, in this patient population. Complementary ancillary studies under review will further address the interrelationships between initial renal function and degree of albuminuria, and/or serial changes in these parameters, with both renal and CVD outcomes in the FAVORIT cohort. An ongoing NIH-funded FAVORIT ancillary study (R01 DK65114-03 """"""""FAVORIT Ancillary Cognitive Trial [FACT]"""""""" is already providing unprecedented data on cognitive function and affect in chronic renal transplantation.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
3U01DK061700-09S2
Application #
8182175
Study Section
Special Emphasis Panel (ZDK1-GRB-8 (J1))
Program Officer
Kusek, John W
Project Start
2001-08-01
Project End
2012-01-31
Budget Start
2010-02-01
Budget End
2011-01-31
Support Year
9
Fiscal Year
2011
Total Cost
$900,000
Indirect Cost
Name
Rhode Island Hospital
Department
Type
DUNS #
075710996
City
Providence
State
RI
Country
United States
Zip Code
02903
Foster, M C; Weiner, D E; Bostom, A G et al. (2017) Filtration Markers, Cardiovascular Disease, Mortality, and Kidney Outcomes in Stable Kidney Transplant Recipients: The FAVORIT Trial. Am J Transplant 17:2390-2399
Jarolim, Petr; Claggett, Brian L; Conrad, Michael J et al. (2017) B-Type Natriuretic Peptide and Cardiac Troponin I Are Associated With Adverse Outcomes in Stable Kidney Transplant Recipients. Transplantation 101:182-190
Scott, T M; Rogers, G; Weiner, D E et al. (2017) B-Vitamin Therapy for Kidney Transplant Recipients Lowers Homocysteine and Improves Selective Cognitive Outcomes in the Randomized FAVORIT Ancillary Cognitive Trial. J Prev Alzheimers Dis 4:174-182
Merhi, Basma; Shireman, Theresa; Carpenter, Myra A et al. (2017) Serum Phosphorus and Risk of Cardiovascular Disease, All-Cause Mortality, or Graft Failure in Kidney Transplant Recipients: An Ancillary Study of the FAVORIT Trial Cohort. Am J Kidney Dis 70:377-385
Park, M; Katz, R; Shlipak, M G et al. (2017) Urinary Markers of Fibrosis and Risk of Cardiovascular Events and Death in Kidney Transplant Recipients: The FAVORIT Trial. Am J Transplant 17:2640-2649
Bansal, Nisha; Carpenter, Myra A; Weiner, Daniel E et al. (2016) Urine Injury Biomarkers and Risk of Adverse Outcomes in Recipients of Prevalent Kidney Transplants: The Folic Acid for Vascular Outcome Reduction in Transplantation Trial. J Am Soc Nephrol 27:2109-21
Dad, Taimur; Tighiouart, Hocine; Joseph, Alin et al. (2016) Aspirin Use and Incident Cardiovascular Disease, Kidney Failure, and Death in Stable Kidney Transplant Recipients: A Post Hoc Analysis of the Folic Acid for Vascular Outcome Reduction in Transplantation (FAVORIT) Trial. Am J Kidney Dis 68:277-286
Weir, Matthew R; Gravens-Muller, Lisa; Costa, Nadiesda et al. (2015) Safety events in kidney transplant recipients: results from the folic Acid for vascular outcome reduction in transplant trial. Transplantation 99:1003-8
Carpenter, Myra A; John, Alin; Weir, Matthew R et al. (2014) BP, cardiovascular disease, and death in the Folic Acid for Vascular Outcome Reduction in Transplantation trial. J Am Soc Nephrol 25:1554-62
Troen, Aron M; Scott, Tammy M; D'Anci, Kristen E et al. (2012) Cognitive dysfunction and depression in adult kidney transplant recipients: baseline findings from the FAVORIT Ancillary Cognitive Trial (FACT). J Ren Nutr 22:268-76.e1-3

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