Omega-3 Fatty Acids That Affect the Immune System in Kidney Transplant Patients

Completed · Early Phase 1

Conditions studied: Kidney Diseases

In brief

The purpose of this study is to evaluate the effectiveness of nutritional supplements in increasing the amount of omega-3 fatty acids (and arginine) in the red blood cell membranes and plasma of kidney transplant patients, and, secondarily, to compare patient compliance. The long-term goal of this study is to develop low risk therapies that will allow improved and lasting survival of donor tissue with minimal suppression of the immune system.

Key facts

Study ID

NCT00047983

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

75

Expected to finish

2004-04-01

Last updated by the study team

2017-01-11

Who can join

Age: 4 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• End-stage renal disease.
• Candidate to receive a living-related donor, living unrelated donor, or first cadaver kidney with at least 1 HLA mismatch.
• Negative crossmatch with the intended donor.
• Adults must have moderate to severe hypertension and/or take at least 1 medication for hypertension daily.
• Willingness to comply with the dietary supplements, including canola oil, a flavored drink mix, or an orange flavored pudding.

You may not qualify if…

• Pregnancy or breast-feeding.
• Women of childbearing age who are not willing or able to practice acceptable methods of contraception.
• HIV-positive.
• Positive test for HBV E-AG/DNA and HCV.
• Received an organ transplant or plan to receive a multiple organ transplant.
• Phenylketonuria.
• Participation in other investigational studies within 30 days of the renal transplant.
• Allergy or anaphylactic reactions to eggs or L-arginine.
• ABO blood incompatibility.
• Children who have previously received more than 5 blood transfusions.
• History of stroke.

Where it is running

• Washington Hospital Center — Washington D.C., District of Columbia, United States
• University of Maryland School of Medicine — Baltimore, Maryland, United States
• Duke University Medical Center — Durham, North Carolina, United States
• University of Cincinnati College of Medicine — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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