Homocysteine Study (HOST)
CSP #453 - Homocysteinemia in Kidney and Endstage Renal Disease Study (HOST)
1 other identifier
interventional
2,003
2 countries
37
Brief Summary
The primary objective of this study is to test the hypothesis that administration of folate, pyridoxine (vitamin B6) and cyanocobalamin (vitamin B12) in high doses to patients with advanced chronic renal failure or end stage renal disease and abnormally high plasma homocysteine levels will lower the homocysteine levels and the death rate compared to patients who receive placebo. The secondary objective is to test the hypothesis that intake of the vitamins compared to placebo decreases the incidence of myocardial infarction, disabling stroke, and amputation of a lower extremity and, in hemodialysis patients, thrombosis of the vascular access.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2001
Longer than P75 for phase_3
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2001
CompletedFirst Submitted
Initial submission to the registry
March 20, 2002
CompletedFirst Posted
Study publicly available on registry
March 22, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2006
CompletedOctober 15, 2010
October 1, 2010
5.3 years
March 20, 2002
October 14, 2010
Conditions
Keywords
Study Arms (2)
1
EXPERIMENTALPAL-40 Active
2
PLACEBO COMPARATORPAL-40 Placebo
Interventions
Eligibility Criteria
You may qualify if:
- Patients will be screened by their plasma homocysteine concentration. They must have a level of at least 15 mM/L to be enrolled in the study.
- Patients will be excluded by any of the following criteria: age less than 21 years, expected life span less than 6 months, pregnancy, metastatic cancer, end-stage liver disease, treatment with methotrexate, other anti-folate medication or anticonvulsants, unreliable or likely noncompliant, participation in another long-term trial, or unwilling or unable to give informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- US Department of Veterans Affairslead
- Pan American Laboratoriescollaborator
- Abbott Diagnostics Divisioncollaborator
Study Sites (37)
VA Medical Center, Birmingham
Birmingham, Alabama, 35233, United States
Health Economics Resource Center (HERC), Menlo Park
Menlo Park, California, 94025, United States
VA Palo Alto Health Care System
Palo Alto, California, 94304-1290, United States
VA San Diego Healthcare System, San Diego
San Diego, California, 92161, United States
VA Eastern Colorado Health Care System, Denver
Denver, Colorado, 80220, United States
VA Connecticut Health Care System (West Haven)
West Haven, Connecticut, 06516, United States
VA Medical Center, DC
Washington D.C., District of Columbia, 20422, United States
VA Medical Center, Bay Pines
Bay Pines, Florida, 33708, United States
North Florida/South Georgia Veterans Health System
Gainesville, Florida, 32608, United States
VA Medical Center, Miami
Miami, Florida, 33125, United States
West Palm Beach VA Medical Center
West Palm Beach, Florida, 33410, United States
Edward Hines, Jr. VA Hospital
Hines, Illinois, 60141-5000, United States
Richard Roudebush VA Medical Center, Indianapolis
Indianapolis, Indiana, 46202-2884, United States
Southeast Veterans Healthcare System, New Orleans
New Orleans, Louisiana, 70112, United States
VA Medical Center, Jamaica Plain Campus
Boston, Massachusetts, 02130, United States
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, 48113, United States
John D. Dingell VA Medical Center, Detroit
Detroit, Michigan, 48201, United States
VA Medical Center, Minneapolis
Minneapolis, Minnesota, 55417, United States
G.V. (Sonny) Montgomery VA Medical Center, Jackson
Jackson, Mississippi, 39216, United States
VA Medical Center, Kansas City MO
Kansas City, Missouri, 64128, United States
VA Western New York Healthcare System at Buffalo
Buffalo, New York, 14215, United States
New York Harbor HCS
New York, New York, 10010, United States
VA Medical Center, Northport
Northport, New York, 11768, United States
VA Medical Center, Syracuse
Syracuse, New York, 13210, United States
VA Medical Center, Bronx
The Bronx, New York, 10468, United States
VA Medical Center, Cleveland
Cleveland, Ohio, 44106, United States
VA Medical Center, Dayton
Dayton, Ohio, 45428, United States
VA Medical Center, Portland
Portland, Oregon, 97201, United States
VA Pittsburgh Health Care System
Pittsburgh, Pennsylvania, 15240, United States
Ralph H Johnson VA Medical Center, Charleston
Charleston, South Carolina, 29401-5799, United States
VA Medical Center, Memphis
Memphis, Tennessee, 38104, United States
VA North Texas Health Care System, Dallas
Dallas, Texas, 75216, United States
Michael E. DeBakey VA Medical Center (152)
Houston, Texas, 77030, United States
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, 23249, United States
VA Puget Sound Health Care System, Seattle
Seattle, Washington, 98108, United States
Zablocki VA Medical Center, Milwaukee
Milwaukee, Wisconsin, 53295-1000, United States
VA Medical Center, San Juan
San Juan, 00921, Puerto Rico
Related Publications (3)
Brady CB, Gaziano JM, Cxypoliski RA, Guarino PD, Kaufman JS, Warren SR, Hartigan P, Goldfarb DS, Jamison RL. Homocysteine lowering and cognition in CKD: the Veterans Affairs homocysteine study. Am J Kidney Dis. 2009 Sep;54(3):440-9. doi: 10.1053/j.ajkd.2009.05.013. Epub 2009 Jul 23.
PMID: 19628319DERIVEDJamison RL, Shih MC, Humphries DE, Guarino PD, Kaufman JS, Goldfarb DS, Warren SR, Gaziano JM, Lavori P; Veterans Affairs Site Investigators. Effect of the MTHFR C677T and A1298C polymorphisms on survival in patients with advanced CKD and ESRD: a prospective study. Am J Kidney Dis. 2009 May;53(5):779-89. doi: 10.1053/j.ajkd.2008.12.023. Epub 2009 Mar 9.
PMID: 19272686DERIVEDJamison RL, Hartigan P, Kaufman JS, Goldfarb DS, Warren SR, Guarino PD, Gaziano JM; Veterans Affairs Site Investigators. Effect of homocysteine lowering on mortality and vascular disease in advanced chronic kidney disease and end-stage renal disease: a randomized controlled trial. JAMA. 2007 Sep 12;298(10):1163-70. doi: 10.1001/jama.298.10.1163.
PMID: 17848650DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Rex L. Jamison
VA Palo Alto Health Care System
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Masking
- DOUBLE
- Sponsor Type
- FED
Study Record Dates
First Submitted
March 20, 2002
First Posted
March 22, 2002
Study Start
May 1, 2001
Primary Completion
August 1, 2006
Study Completion
September 1, 2006
Last Updated
October 15, 2010
Record last verified: 2010-10