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More on New Test to Detect Early Kidney Transplant Rejection

Research and Clinical Trials

Return to New Test to Detect Early Kidney Transplant Rejection Overview

More on New Test to Detect Early Kidney Transplant Rejection

New Test to Detect Early Kidney Transplant Rejection

NEW YORK (May 1, 2013)

Organ rejection is the most common and serious complication of kidney transplantation. NewYork-Presbyterian/Weill Cornell Medical Center researchers have developed a urine test that is 85 percent accurate for detecting early signs of organ rejection in transplanted kidneys and identifying which patients may be at risk for rejection weeks or months before they develop any symptoms. Patients who show signs of early organ rejection may have changes made to the medications they are taking to promote the health of the new kidney and prevent rejection.

Manikkam Suthanthiran, M.B., B.S.
Manikkam Suthanthiran,
M.B., B.S.

Such a noninvasive test is sorely needed to help improve the longevity of kidney transplants and the lives of patients who receive them. "With this test, we have – for the first time – the opportunity to manage transplant patients in a more precise, individualized fashion," says the study's lead author, Manikkam Suthanthiran, M.B., B.S., the Stanton Griffis Distinguished Professor of Medicine at Weill Cornell Medical College and chief of transplantation medicine, nephrology and hypertension at NewYork-Presbyterian/Weill Cornell Medical Center. "This is good news, since it moves us from the current 'one-size-fits-all' treatment approach to a much more personalized plan." A clinical study evaluating the test was published in the July 4, 2013 issue of the New England Journal of Medicine.

After organ transplantation, patients receive "immunosuppressive therapy" – a combination of drugs given to keep the recipient's immune system from attacking the donated organ. Too little immunosuppressive therapy can lead to organ rejection, while too much can lead to infection or even cancer. The new urine test can help doctors refine the right amount of immunosuppressive drugs to give a patient.

Darshana Manji Dadhania, M.D.
Darshana Manji
Dadhania, M.D.

The urine test is a "gene expression profile" that measures three genetic molecules in a sample of urine. A composite score calculated using the test is used to determine if changes need to be made to a patient's immunosuppressive therapy. If the score starts to rise over time, the patient may be at risk for rejection and require more immunosuppressive therapy. If the score remains steady, the patient is not at risk for organ rejection and can stay on the same treatment plan.

The new test is also noninvasive. Until now, doctors have measured patients' levels of urinary creatinine to assess kidney function. But creatinine can rise in response to other problems – even simple dehydration – prompting unnecessary needle-stick biopsies to examine kidney tissue for signs of rejection. This new test can help doctors avoid those needle biopsies.

The clinical trial in the New England Journal of Medicine was a five-center study (which also included NewYork-Presbyterian/Columbia University Medical Center) of nearly 500 kidney transplant patients. It showed that the test was highly accurate for distinguishing between kidney biopsy specimens showing signs of organ rejection at the cellular level and tissue samples that did not show these signs. The study was supported with funding from the National Institutes of Health, which is interested in submitting the test to the U.S. Food and Drug Administration for approval.

"Our goal is to provide the most effective care possible for our kidney transplant patients, and that means individualizing their care after transplant," adds study co-author Darshana Manji Dadhania, M.D., associate professor of medicine and medicine in surgery at Weill Cornell Medical College and associate attending physician at NewYork-Presbyterian Hospital."Using an innovative test like this will eliminate unnecessary biopsies and provide a yardstick to measure adequate immunosuppression to keep organs – and our patients – healthy."

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