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| Sponsors and Collaborators: |
Department of Veterans Affairs 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 |
|
Renal Failure End Stage Renal Disease |
Drug: PAL-40 Active Drug: PAL-40 Placebo |
Phase III |
| MedlinePlus related topics: | Kidney Failure |
| Drug Information available for: | Folic acid Vitamin B 12 Hydroxocobalamin Vitamin B 6 5-Hydroxy-6-methyl-3,4-pyridinedimethanol hydrochloride Pyridoxine Homocysteine |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study |
| Official Title: | CSP#453 - Homocysteinemia in Kidney and Endstage Renal Disease Study (HOST) |
| Estimated Enrollment: | 2003 |
| Study Start Date: | May 2001 |
| Study Completion Date: | August 2006 |
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Show Detailed Description |
Eligibility
| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations |
Show 37 Study Locations |
| Department of Veterans Affairs |
| Pan American Laboratories |
| Abbott Diagnostics Division |
More Information
| Study ID Numbers: | 453 |
| First Received: | March 20, 2002 |
| Last Updated: | March 15, 2007 |
| ClinicalTrials.gov Identifier: | NCT00032435 |
| Health Authority: | United States: Food and Drug Administration |
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