January 14, 1998

New Transplant Rejection Drug Shows Significant Results; IU Team Leads Pediatric Research

New England Journal of Medicine

INDIANAPOLIS --Adults and children suffering from kidney failure now have a better chance for a successful transplant because of a drug tested by researchers at the Indiana University School of Medicine. The full research report will appear in the January 15 edition of the New England Journal of Medicine.

The monoclonal antibody called Zenapax blocks immune cells from attacking the new kidney during the first eight weeks after transplant, which is the riskiest period for organ rejection to occur. Zenapax is administered together with standard anti-rejection drugs. One of its best features is that it causes no additional side effects, even with increased dosage, a common problem with most anti-rejection drugs. Since anti-rejection drugs suppress the body’s immune system so it won’t attack the new organ, patients are vulnerable to severe infections and serious side effects.

IU Associate Professor of Surgery and Microbiology/Immunology Mark Pescovitz, MD, and his team were the lead pediatric research group on the Zenapax trial. “The great thing about Zenapax is that it is programmed to attack very specific cells during a critical time,” says Dr. Pescovitz. Patients only take Zenapax during the first eight-weeks after transplant and the effect lasts for 12 weeks. They must continue to take other anti-rejection drugs for the rest of their lives.

During a six-month study of 260 adult patients, only 22 percent of patients with Zenapax added to the standard drug regimen experienced signs of rejection, compared to 35 percent on standard anti-rejection treatment. Further testing in children is currently underway, but so far the results are excellent. “We saw the same absence of side effects in the children that was noted in adults. The children also were able to leave the hospital sooner,” says Pescovitz. Children who were part of the trial at IU were transplanted at Riley Hospital for Children.

About 38,000 Americans are on a waiting list for kidney transplants. The IU transplant ream performs an average of 90-100 kidney transplants per year. Researchers hope that Zenapax will prove to be effective for patients receiving other organs as well. The next clinical trials will test liver and heart transplant patients.

There has been an explosion of clinical research for anti-rejection and anti-viral drugs for transplant patients during the last few years. The IU Transplant Team is one of the major clinical research sites in the United States It has been involved with the development of seven new drugs during the last five years. Research at IU includes work on an NIH study looking at replacements for the drug prednisone, a common anti-rejection drug that causes many side effects.

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