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    Steroids Can Be Avoided in Pediatric Kidney Transplants

    Contact: Amy Weitz, 510-206-1855
    weitza@sutterhealth.org

    Landmark Clinical Trial Shows Steroids Can Be Avoided in Pediatric Kidney Transplants Without Greater Risk of Rejection

    Groundbreaking research is changing treatment protocols around the world; non-steroid treatment results in dramatic benefits and fewer side effects

    San Francisco – September 27, 2012 -- A landmark multi-center trial has shown that steroids can be avoided in treating children who have had a kidney transplant with no greater risk of transplant rejection. The findings, which run counter to long-held beliefs, could prompt a sea change in how children are treated post transplant and promise to improve the health and quality of life for thousands of children and teens.

    In the most extensive study ever conducted, involving 12 medical centers and 130 children throughout the US, researchers found that alternative treatments could be just as effective as steroids with fewer short-term and long-term side effects. The results are setting a new standard for kidney transplant treatment for low-risk children with end-stage renal disease.

    “Until recently, the conventional wisdom was that steroids were necessary to reduce acute rejection after a kidney transplant,” said Minnie Sarwal, MD, FRCP, PhD, a professor of pediatrics and director of the BIOMARC program at the California Pacific Medical Center Research Institute (CPMCRI, a Sutter Health affiliate) and lead author of the study, which appears in the October 2012 issue of the American Journal of Transplantation. “But steroid treatment is especially harmful for young people – causing a host of problems from growth retardation and body disfigurement to diabetes, bone loss, cataracts and increased risk of infection,” she noted. “Finding a way to protect against transplant rejection without steroids is a tremendous advance in patient care.”

    The randomized, three-year prospective study, co-led by Dr. Sarwal and Oscar Salvatierra, Jr., MD, emeritus professor of surgery at Stanford University, involved two groups of pediatric transplant patients who were placed in either the ‘steroid-free’ or ‘steroid-based’ arm. Dr. Sarwal’s 12-member research team, which began its work at Stanford University before relocating to CPMCRI, identified a new protocol to replace steroids by using a longer treatment period with an immunosuppressive regimen (consisting of an IL2R monoclonal antibody) and eventually maintaining children on fewer drugs and lower doses than if they were on a steroid-based protocol. The avoidance of steroids improved growth in young children and allowed for significant ‘catch-up’ growth after transplantation. The children in the study received primary kidney transplants between 2004 and 2006.

    Fewer side effects, no increased risk in steroid-free group
    In addition to showing that there was no difference in transplant rejection between the two arms of the trial, the study also showed fewer side effects in the steroid-free group, including lower systolic blood pressure, lower total cholesterol levels and lower rates of viral infections. Moreover, in a companion study involving the same participants, more than 650 biopsies taken over a two-year period showed no difference in tissue damage in the transplant between the two groups of children. This study appears separately in the October 2012 issue of the American Journal of Transplantation.

    Compliance can be greater with non-steroid treatment
    “These findings are important not only because they show we can move away from steroid treatment for kids receiving kidney transplants, but also because doing so most likely will result in greater compliance with treatment overall,” said Dr. Sarwal. “We know that young people in particular are often reluctant to adhere to a strict steroid regimen because of the serious debilitating effects – and this lack of compliance can have life-threatening results. If we can remove this treatment complication, we can hope to see better patient outcomes.”

    Dr. Sarwal, who is an internationally known expert in the field of pediatric kidney transplant research, pointed out that much work still needs to be done to further reduce transplant injury and extend the life of the transplant for both children and adults. “Our research has come a long way but even now the average lifespan for a kidney transplant is only 11 years,” Dr. Sarwal said. “Identifying ways to extend the transplant lifespan and further improve patient health is the ultimate goal.”

    The above-referenced studies, “Complete Steroid Avoidance Is Effective and Safe in Children With Renal Transplants: A Multicenter Randomized Trial With Three-Year Follow-Up” and “Subclinical Inflammation and Chronic Renal Allograft Injury in a Randomized Trial on Steroid Avoidance in Pediatric Kidney Transplantation,” were supported by the National Institutes of Health, Astellas and Roche Pharmaceuticals.

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