Translational Science in Transplantation

Two large NIH funded multicenter trials in transplantation are ongoing. Barbara Murphy, MD, is leading a genomics in transplantation study studying mechanisms of late graft injury (GOCAR) and Peter Heeger, MD runs the clinical trials in Organ Transplantation (CTOT) consortium evaluating biomarkers as predictors of heart or kidney transplant outcome. Both studies are open to enrollment for new patients. Additional efforts are focused on mechanisms of ischemic injury and the pathophysiology of rejection in kidney and liver transplant patients.

Principal Investigator: Jonathan Bromberg, MD, PhD
Project Title: Coronary screening in transplantation (COST) feasibility study. NIH sponsored (KIDNEY)
Project Title: Urinary kidney injury molecule-1 (KIM-1) as diagnostic biomarker of proximal tubular injury in adult and pediatric kidney transplant recipients. NIH sponsored (KIDNEY)

Principal Investigator: Barbara Murphy, MD
Project Title: GOCAR - Genomics of Chronic Renal Allograft Rejection. NIH sponsored (KIDNEY)

Principal Investigator: Peter Heeger, MD
Project Title: CTOT - Noninvasive monitoring to predict outcome in de novo kidney transplant recipients. NIH sponsored (KIDNEY)

Principal Investigator: Lawrence Liu, MD
Project Title: A multicenter group to study acute liver failure: Data and specimen collection protocol Acute liver injury and N-acetylcysteine in the treatment of ALF not cause by acetaminophen: NIH sponsored. (LIVER)

Principal Investigator: Barbara Murphy, MD; Thomas Schiano, MD
Project Title: Solid Organ Transplant in kidney and Liver HIV patients: Multi-Site Study. NIH sponsored. (KIDNEY AND LIVER)

Principal Investigator: Fred Suchy, MD
Project Title: Biliary Atresia Research Consortuium (BARC) – A randomized, double-blinded, placebo-controlled trial of corticosteriois therapy following portoenterostomy in infants with biliary atresa. NIH sponsored. (KIDNEY)
Project Title: Biliary Atresia Research Consortium (BARC) – A Prospective database of infants with cholestasis. NIH sponsored (LIVER)
Project Title: Biliary Atresia in Infants and Children (LIVER)
Project Title: The Rare Liver Diseases Network (CLiC) Longitudinal Study of Genetic Causes of Intrahepatic Cholestasis. NIH sponsored (LIVER)

Principal Investigator: Nanda Kerkar, MD
Project Title: Functional Outcomes in Pediatric Transplantation (FOG). NIH Sponsored. (LIVER)
Project Title: A multi-center study of the safety and efficacy of N-Acetylcysteine in the treatment of acute liver failure not caused by acetaminophen in pediatric patients. NIH sponsored. (LIVER)
Project Title: Pediatric ALF Study Group (PALF) NIH sponsored (LIVER)

Industry/Pharmaceutical Research

The RMTI is participating in multiple well designed clinical trials to assess the utility of novel approaches for prevention and treatment of rejection and graft loss following transplantation, with a particular focus on kidney and liver transplantation.

Principal Investigator: Lawrence Liu, MD
Project Title: Study of the antiviral activity of entecavir in adult patients receiving liver transplant due to chronic hepatitis B (LIVER)

Principal Investigator: Nanda Kerkur, MD
Project Title: Evaluation of the pharmacokinetics, safety, tolerability and efficacy of Entecavir in pediatric subjects with chronic hepatitis B infection who are HBeAg positive (PEDS LIVER)

Principal Investigator: Thomas Schiano, MD
Project Title: Phase II open label, randomized study to evaluate the efficacy and safety of the combination product Emtriitabine/Tenofovir Disoproxil Fumarate in the presence or absence of HBIg in preventing recurrence of chronic hepatitis B post-transplant. (LIVER)
Project Title: Interferon-induced graft dysfunction after liver transplant:a multicenter case-controlled study. (LIVER)
Project Title: Evaluation of HepaGam B in combination with antiviral treatment in Hepatitis B liver transplant patients. (LIVER)

Principal Investigator: Juan Del Rio Martin, MD
Project Title: A phase II open-label, multi-center, randomized trial to demonstrate the PK’s of LCP-Tacro tablets once daily and Prograf caps twice daily in adult de novo liver transplant patients. (LIVER)

Principal Investigator: Susan Lerner, MD
Project Title: Phase II randomized, open-label, parallel group, multi-center study to assess safety and efficacy of alefacept in de novo kidney transplant. (KIDNEY)

The following individuals run basic science laboratories with an interest in transplantation immunobiology. Specific research projects are outlined at each of the laboratory websites:

Jonathan Bromberg, MD, PhD
Bromberg Laboratory

Peter Heeger, MD

Barbara Murphy, MD

Rajani Dinavahi, MD

Bernd Schroppel, MD

Kishore Iyer, MD