Homocysteine Study (HOST) - Full Text View

Sponsor:	Department of Veterans Affairs
Collaborators:	Pan American Laboratories Abbott Diagnostics Division
Information provided by:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00032435

Purpose

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.

Condition	Intervention	Phase
End Stage Renal Disease Renal Failure	Drug: PAL-40 Active Drug: PAL-40 Placebo	Phase III

Study Type:	Interventional
Study Design:	Double-Blind, Placebo Control
Official Title:	CSP #453 - Homocysteinemia in Kidney and Endstage Renal Disease Study (HOST)

Resource links provided by NLM:

MedlinePlus related topics: Kidney Failure

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Estimated Enrollment:	2003
Study Start Date:	May 2001
Study Completion Date:	September 2006
Primary Completion Date:	August 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental PAL-40 Active	Drug: PAL-40 Active
2: Placebo Comparator PAL-40 Placebo	Drug: PAL-40 Placebo

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Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00032435

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Locations

United States, Alabama
VA Medical Center, Birmingham
Birmingham, Alabama, United States, 35233
United States, California
VA Palo Alto Health Care System
Palo Alto, California, United States, 94304-1290
Health Economics Resource Center (HERC), Menlo Park
Menlo Park, California, United States, 94025
VA San Diego Healthcare System, San Diego
San Diego, California, United States, 92161
United States, Colorado
VA Eastern Colorado Health Care System, Denver
Denver, Colorado, United States, 80220
United States, Connecticut
VA Connecticut Health Care System (West Haven)
West Haven, Connecticut, United States, 06516
United States, District of Columbia
VA Medical Center, DC
Washington, District of Columbia, United States, 20422
United States, Florida
VA Medical Center, Bay Pines
Bay Pines, Florida, United States, 33708
VA Medical Center, Miami
Miami, Florida, United States, 33125
West Palm Beach VA Medical Center
West Palm Beach, Florida, United States, 33410
North Florida/South Georgia Veterans Health System
Gainesville, Florida, United States, 32608
United States, Illinois
Edward Hines, Jr. VA Hospital
Hines, Illinois, United States, 60141-5000
United States, Indiana
Richard Roudebush VA Medical Center, Indianapolis
Indianapolis, Indiana, United States, 46202-2884
United States, Louisiana
Southeast Veterans Healthcare System, New Orleans
New Orleans, Louisiana, United States, 70112
United States, Massachusetts
VA Medical Center, Jamaica Plain Campus
Boston, Massachusetts, United States, 02130
United States, Michigan
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, United States, 48113
John D. Dingell VA Medical Center, Detroit
Detroit, Michigan, United States, 48201
United States, Minnesota
VA Medical Center, Minneapolis
Minneapolis, Minnesota, United States, 55417
United States, Mississippi
G.V. (Sonny) Montgomery VA Medical Center, Jackson
Jackson, Mississippi, United States, 39216
United States, Missouri
VA Medical Center, Kansas City MO
Kansas City, Missouri, United States, 64128
United States, New York
VA Medical Center, Bronx
Bronx, New York, United States, 10468
VA Western New York Healthcare System at Buffalo
Buffalo, New York, United States, 14215
New York Harbor HCS
New York, New York, United States, 10010
VA Medical Center, Northport
Northport, New York, United States, 11768
VA Medical Center, Syracuse
Syracuse, New York, United States, 13210
United States, Ohio
VA Medical Center, Cleveland
Cleveland, Ohio, United States, 44106
VA Medical Center, Dayton
Dayton, Ohio, United States, 45428
United States, Oregon
VA Medical Center, Portland
Portland, Oregon, United States, 97201
United States, Pennsylvania
VA Pittsburgh Health Care System
Pittsburgh, Pennsylvania, United States, 15240
United States, South Carolina
Ralph H Johnson VA Medical Center, Charleston
Charleston, South Carolina, United States, 29401-5799
United States, Tennessee
VA Medical Center, Memphis
Memphis, Tennessee, United States, 38104
United States, Texas
VA North Texas Health Care System, Dallas
Dallas, Texas, United States, 75216
Michael E. DeBakey VA Medical Center (152)
Houston, Texas, United States, 77030
United States, Virginia
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, United States, 23249
United States, Washington
VA Puget Sound Health Care System, Seattle
Seattle, Washington, United States, 98108
United States, Wisconsin
Zablocki VA Medical Center, Milwaukee
Milwaukee, Wisconsin, United States, 53295-1000
Puerto Rico
VA Medical Center, San Juan
San Juan, Puerto Rico, 00921

Sponsors and Collaborators

Department of Veterans Affairs

Pan American Laboratories

Abbott Diagnostics Division

Investigators

Study Chair:

Rex L. Jamison

VA Palo Alto Health Care System

More Information

Publications:

Jamison 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.

Jamison RL, Hartigan P, Gaziano JM, Fortmann SP, Goldfarb DS, Haroldson JA, Kaufman J, Lavori P, McCully KS, Robinson K. Design and statistical issues in the homocysteinemia in kidney and end stage renal disease (HOST) study. Clin Trials. 2004;1(5):451-60.

Jamison 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. Epub 2009 Mar 9.

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. Epub 2009 Jul 23.

Responsible Party:	Department of Veterans Affairs ( Jamison, Rex - Study Chair )
Study ID Numbers:	453
Study First Received:	March 20, 2002
Last Updated:	October 14, 2009
ClinicalTrials.gov Identifier:	NCT00032435 History of Changes
Health Authority:	United States: Federal Government; United States: Food and Drug Administration

Keywords provided by Department of Veterans Affairs:

folate, pyridoxine,vitamin B6,cyanocobalamin,homoc

Additional relevant MeSH terms:

Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic

Kidney Failure, Chronic
Kidney Diseases
Kidney Failure

ClinicalTrials.gov processed this record on November 20, 2009