Homocysteine Study (HOST)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00032435 |
Recruitment Status :
Completed
First Posted : March 22, 2002
Last Update Posted : October 15, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
End Stage Renal Disease Renal Failure | Drug: PAL-40 Active Drug: PAL-40 Placebo | Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 2003 participants |
Masking: | Double |
Official Title: | CSP #453 - Homocysteinemia in Kidney and Endstage Renal Disease Study (HOST) |
Study Start Date : | May 2001 |
Actual Primary Completion Date : | August 2006 |
Actual Study Completion Date : | September 2006 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
PAL-40 Active
|
Drug: PAL-40 Active |
Placebo Comparator: 2
PAL-40 Placebo
|
Drug: PAL-40 Placebo |

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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:

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00032435

Study Chair: | Rex L. Jamison | VA Palo Alto Health Care System |
Responsible Party: | Jamison, Rex - Study Chair, Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00032435 |
Other Study ID Numbers: |
453 |
First Posted: | March 22, 2002 Key Record Dates |
Last Update Posted: | October 15, 2010 |
Last Verified: | October 2010 |
folate pyridoxine vitamin B6 cyanocobalamin homoc |
Kidney Diseases Kidney Failure, Chronic Urologic Diseases Renal Insufficiency, Chronic Renal Insufficiency |