Duke Health Referring Physicians

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Clinical Trials Improve Abdominal Transplant

Research aims to increase access and decrease post-transplant side effects

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Physician researchers in lab with one looking in a microscope

Duke Health continues to lead in research, with recent and current clinical trials that seek to increase access to transplant and improve outcomes for recipients. Ongoing trials in abdominal transplant include testing ways to help improve education about transplant options as well as testing an alternative anti-rejection drug to decrease side effects.

Living donation education: the STEPS study

The System Interventions to Achieve Early and Equitable Transplants (STEPS) study, led at Duke by abdominal transplant surgeon Debra L. Sudan, MD, and her colleagues in the Department of Medicine, introduced additional education on living donation to candidates for kidney transplant. “Historically, the African-American population has had less living donation than patients of other races,” says Sudan. “We hoped to achieve equity in the use of living donation through education.”

The trial has completed data collection and is in the analysis phase. Even if the educational arm of the study doesn’t improve living donation rates, the study still points toward useful information: “If the data indicate that it’s not education that’s the barrier, that’s still an important finding,” says Sudan. “Other barriers may still be prohibitive, so understanding these challenges helps us offer the resources to support these potential donors.”

Although not the only site for this study, Duke was a particularly good fit because of the diverse patient population. “We have a high proportion of Black patients at Duke compared with a much lower percentage nationwide,” Sudan says. “This study helps to bring our attention to this issue. As transplant centers, we need to focus on this more to ensure everyone achieves the best outcome.” 

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New anti-rejection drugs: the BESTOW study

The BESTOW study, led at Duke by abdominal transplant surgeon Kadiyala V. Ravindra, MBBS, compares the efficacy and safety of a new anti-rejection drug over the current standard of care. The study hypothesizes that tegoprubart, the monoclonal antibody therapy being tested, could improve long-term kidney function and decrease the risk of diabetes versus the current standard of care medicine, tacrolimus.

“Success in solid organ transplant was largely achieved because of current anti-rejection drugs,” says Ravindra. “However, these drugs come with their own side effects: They cause an increased risk of diabetes, hypertension, and kidney damage long term, sometimes requiring retransplantation. The new drug explores a new pathway for possibly preventing rejection and preserving kidney function long term with potentially longer graft & patient survival.”

Tegoprubart has been shown to be safe in animal and phase one trials before this international phase two trial. “Our patients’ data is very promising so far,” Ravindra says.

“Duke has led the way in offering research opportunities to any of our patients who might be eligible,” says Ravindra. “We are ideally suited for this type of research with our multidisciplinary teams, our expertise, and our infrastructure to keep patient safety at the forefront.”