CHAPEL HILL - Oct 23, 2018 - For Immediate Release

Rho Supports Pediatric Heart Transplantation Study

CRO serves as the Statistical and Clinical Coordinating Center for NIH-sponsored study

Chapel Hill, NC  ̶  October 22, 2018  Rho, a full-service contract research organization (CRO) focused on bringing new products to market through a full range of product development services, is part of a newly published study that is helping medical professionals better understand pediatric heart transplantation. The study, “Alloantibodies in Pediatric Heart Transplantation,” with results published in three manuscripts in the American Journal of Transplantation, investigated the consequences of alloantibodies-antibodies that recognize antigens from a genetically different individual-in pediatric heart recipients. These antibodies may be present prior to transplant, or they may arise after transplant. The research was funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).

This observational study of 240 pediatric transplant recipients is the first prospective and multi-institutional study to examine an important class of antibodies known as human leukocyte antigen (HLA) antibodies among the pediatric heart transplant population. The presence of these antibodies could lead to rejection of the transplanted organ. The study found that the composite incidence of death, repeat transplantation, or rejection with reduced function of the heart at 12 months post-transplantation did not differ between varying levels of antibodies.

Fortunately, organ failure is very uncommon in children, but when it does occur in pediatric patients, transplantation is usually the best therapeutic option. “Working with the NIH’s collaborative Clinical Trials in Organ Transplantation in Children group, we have been able to better understand pediatric heart transplantation, and hope that this study can help improve care for the children who need it,” said Kristen Mason, MS, senior biostatistician, Rho.   

The trial provided a wealth of longitudinal biopsy, antibody, immunosuppression management, and laboratory data collected both pre- and post-transplant. Researchers observed good short-term graft and patient survival, regardless of the presence of antibodies. The findings also demonstrate that with perioperative removal of antibodies and appropriate immunosuppression, patients with high levels of antibodies can achieve similar outcomes as those with no or low antibodies.

Additionally, the study found that development of newly detected donor-specific antibodies within the first year was not common, but when found, such antibodies developed early and were associated with an increased risk of acute cellular rejection.

For this study, Rho was the full-function Statistical and Clinical Coordinating Center, providing support for statistical analysis, safety monitoring, data management, clinical monitoring, as well as supporting study protocol and manuscript development. Mason, as well as Rho employees Brian Armstrong, MS, and David Iklé, PhD, were the biostatisticians for the study and were involved in writing the three manuscripts, of which they are co-authors.

ARTICLES:

Zuckerman WA, Zeevi A, Mason KL, Feingold B, Bentlejewski C, Addonizio LJ, Blume ED, Canter CE, Dipchand AI, Hsu DT, Shaddy RE, Mahle WT, Demetris AJ, Briscoe DM, Mohanakumar T, Ahearn JM, Iklé DN, Armstrong BD, Morrison Y, Diop H, Odim J, Webber SA. Study rationale, design, and pretransplantation alloantibody status: A first report of Clinical Trials in Organ Transplantation in Children-04 (CTOTC-04) in pediatric heart transplantation. Am J Transplant. 2018 Sep;18(9):2135-2147. doi: 10.1111/ajt.14695. Epub 2018 Mar 23. PMID: 29446208. PMC6093810 [Available on 2019-09-01]

Dipchand AI, Webber S, Mason K, Feingold B, Bentlejewski C, Mahle WT, Shaddy R, Canter C, Blume ED, Lamour J, Zuckerman W, Diop H, Morrison Y, Armstrong B, Iklé D, Odim J, Zeevi A; CTOTC-04 Investigators. Incidence, characterization, and impact of newly detected donor-specific anti-HLA antibody in the first year after pediatric heart transplantation: A report from the CTOTC-04 study. Am J Transplant. 2018 Sep;18(9):2163-2174. doi: 10.1111/ajt.14691. Epub 2018 Mar 24. PMID: 29442424. PMC6092243 [Available on 2019-09-01]

Webber S, Zeevi A, Mason K, Addonizio L, Blume E, Dipchand A, Shaddy R, Feingold B, Canter C, Hsu D, Mahle W, Armstrong B, Morrison Y, Iklé D, Diop H, Odim J; CTOTC-04 investigators. Pediatric Heart Transplantation Across a Positive Crossmatch: First Year Results from the CTOTC-04 Multi-Institutional Study. Am J Transplant. 2018 Sep;18(9):2148-2162. doi: 10.1111/ajt.14876. Epub 2018 May 28. PMID: 29673058

Research reported in these publications was supported by NIAID/NIH under Award Numbers UM2AI117870 and U01AI077867. The content is solely the responsibility of the authors and does not represent the official views of NIH. Additional details are available at ClinicalTrials.gov using the identifier NCT01005316.

To learn more about Rho, please visit www.rhoworld.com.

About Rho

Rho, a privately-held, full-service contract research organization (CRO) located in Chapel Hill, NC, provides a full range of clinical research services across the entire drug development process. For more than 35 years, Rho has been a trusted partner to some of the industry’s leading pharmaceutical, biotechnology, and medical device companies as well as academic and government organizations. Our commitment to excellence, our innovative technologies, and our therapeutic expertise accelerate time to market, maximize returns on investment, and lead to an exceptional customer experience. Please follow us on Twitter.

###