IRB Number:

1965-04

Trial Status:

Open for Enrollment

Phase: III

Why is this study being done?

This research study is a multi-center trial to determine whether high doses of folic acid and vitamins B6 and B12 can reduce the rate of cardiovascular disease in renal transplant patients by lowering homocysteine levels.

Who is Eligible to Participate in the Study?

Participants may be eligible for this research study if:

• they have had a renal transplant at least 6 months ago


• are between the ages of 35 an 75, and are in general good health


• they have not had a recent heart attack, stroke or cardiovascular surgery


• they qualify through blood work and questionnaires and are willing to take the study medication

Minimum Age:

35

Maximum Age:

75

What is Involved With this Study?

Participants will be seen for a screening visit where you will have physical measurements, blood pressure and a history taken. Blood and urine samples will be taken and be tested to see if you qualify for the study. The participant will continue to have their routine, yearly clinic visit with their transplant doctor for a physical, history, medication review and blood and urine samples.

A small portion of the blood and urine collected will be stored for future testing related only to the risk for cardiac kidney disease. Participants will also have a phone "visit" every 6 months for a short medical history. Participants will be asked to take the study medication provided.

How long will the Study run?

Participants will be enrolled in this research study for up to 5 years.

Who can I Contact for Additional Information on this Trial?

For more information or to participate in this research study, please contact Brenda Ingalls Hanson at (507) 538-2918.

What is/are the Locations of this Clinical Trial?

• Rochester, MN

Last updated: 09/14/2005