May 13, 2005

Researchers test antibody that may stop kidney failure

Featured Image

Jennifer Ezell, left, an acute care nurse practitioner, was given the Vanderbilt University School of Nursing Faculty Nurse Award by Marilyn Dubree, chief nursing officer, at the annual State of Nursing address last week.
photo by Kats Barry

Researchers test antibody that may stop kidney failure

Vanderbilt Medical Center will embark on a phase one clinical trial of a new antibody that could be used in children to protect them from hemolytic uremic syndrome (HUS).

HUS is a leading cause of acute renal failure in children and is typically a complication that may follow infection from E. coli. There are few options currently available for the prevention and treatment of HUS. It is hoped that this antibody can be given at the onset of symptoms and prevent HUS from developing.

The Vanderbilt research study will determine the safest and most effective dose of the investigational product, a protein called a monoclonal antibody (chimeric anti-shiga toxin 1 (cáStx1).

This study is the first time cáStx1 is being given to humans. Vanderbilt will be the only site in the country testing this new product. Twenty-five adults will be screened and four different dosages of the product will be evaluated.

“The intended usage of this product is to protect children infected with E. coli-producing Stxs against developing hemolytic uremic syndrome,” explained Kathryn Edwards M.D., principal investigator for the study.

CáStx1 was created to prevent E.coli infections from progressing to HUS, a complication that may follow certain food borne infections. HUS may cause kidney failure, anemia, and bleeding problems and is most commonly found in children and elderly adults. HUS is very serious in children and is a leading cause of kidney failure.

To determine the highest and safest dose, participants will receive different dose levels of the drug.

Volunteers will be split up into groups. The first group will receive the lowest dose level, and if no severe side effects are noted, the dose will be increased for the next group of participants.

For every group, the dose will be increased unless participants have side effects. If there are side effects, more participants may receive the lower dose.

For more information contact Deborah Hunter at: