Emory Transplant Center Active Clinical Trials

The Emory Transplant Center Clinical Research Program provides support for clinical trials encompassing end-organ diseases and solid organ transplantation for the Kidney, Kidney/Pancreas, Liver, Lung, Islet and Vascularized Composite Allograft programs. It is the goal of the ETC Clinical Research Program to maintain an active and diverse research portfolio that benefits our patients by providing opportunities to participate in cutting edge research initiatives, to advance the field of transplantation and to allow our investigators to contribute to scientific discovery.

Overall, our group supports 34 studies with 8 new projects in development. The program currently offers:

• 18 actively enrolling trials

• Includes 9 interventional trials

Kidney Transplantation

“Optimization of Belatacept Usage as a Means of Avoiding CNI and steroids in Renal Transplantation” (CTOT-10)
Principal Investigator: Ken Newell, MD

“Use of Belatacept during Post Depletional Repopulation to Facilitate Tolerance in Renal Allograft Recipients”(BMS IM 103-036)
Principal Investigator: Allan D. Kirk, MD, PhD

“Controlled, Randomized, Prospective, Double-Blind, Multicenter, Phase I/II, Dose-Escalation Study of the Safety, PK, and Clinical Activity of I5NP for Prophylaxis of Delayed Graft Function in Patients Undergoing Deceased Donor Kidney Transplantation”
Principal Investigator: Paul Tso, MD

“An Observational Study to Assess the Prevalence of a Tolerance Signature in Renal Transplant Recipients” (ITN524st/CTOT-12)
Principal Investigator: Ken Newell, MD

Liver Transplantation

Liver Transplant

"A Multi-Center, Randomized, Prospective, Open-Label Phase III Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Hepatitis C Immune Globulin (HCIG) in Orthotopic Liver Transplant Recipients (Biotest study)"
Principal Investigator: James Spivey, MD

"International Randomized Trial to Evaluate the Effectiveness of the Portable Organ Care System (OCS™) Liver for Preserving and Assessing Donor Livers for Transplantation (OCS Liver PROTECT Trial)"
Principal Investigator: Joseph Magliocca, MD

Pre Liver Transplant/Liver Disease

"A Phase 2a Study to Evaluate the Safety and Tolerability of OCR-002 (ornithine phenylacetate) in the Treatment of Patients with Acute Liver Failure/Severe Acute Liver Injury (STOP-ALF)"
Principal Investigator: Ram Subramanian, MD

"Multicenter, Randomized Phase 2B Study to Evaluate the Efficacy, Safety and Tolerability of OCR-002 (ornithine phenylacetate) in Hospitalized Patients with Cirrhosis and Associated Hyperammonemia with an Episode of Hepatic Encephalopathy (Ocera STOP-HE Study)"
Principal Investigator: Ram Subramanian, MD

"A Multi-Center Group to Study Acute Liver Failure"
Principal Investigator: Ram Subramanian, MD

"Observational, Post-marketing Renal Safety Surveillance Registry in Subjects with Chronic Hepatitis B (HBV) Infection with Decompensated Liver Disease Receiving Nucleotide/side Therapy"
Principal Investigator: James Spivey, MD

"A Phase 3b, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Subjects with Primary Biliary Cirrhosis. Protocol 747-302"
Principal Investigator: Ryan Ford, MD

"A Phase 3, Double-Blind, Randomized, Long-Term, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Obeticholic Acid in Subjects with Nonalcoholic Steatohepatitis. REGENERATE study. Protocol 747-303"
Principal Investigator: Ryan Ford, MD

"A Randomized, Double-Blind, Exploratory Phase 2 Study to Assess the Effects of ARI–3037MO on Hepatic Fat Metabolism in Patients with Dysglycemia and Evidence of Hepatic Steatosis with Nonalcoholic Fatty Liver Disease or Nonalcoholic Steatohepatitis. Protocol: ARI-3037MO-006"
Principal Investigator: Ram Subramanian, MD

"A Randomized, Open-Label, Multicenter, Controlled, Pivotal Study to Assess Safety and Efficacy of ELAD® in Subjects with Alcohol-Induced Liver Decompensation (AILD). VTL-308"
Principal Investigator: Ram Subramanian, MD

"A Phase 3b, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Ledipasvir/Sofosbuvir, with or without Ribavirin, in HCV Infected Subjects Who Have Failed Prior Treatment with Sofosbuvir-based Therapies. Protocol GS-US-337-1746"
Principal Investigator: Anjana Pillai, MD

"Health Literacy Amongst Liver Transplant Candidates"
Principal Investigator: Joel Wedd, MD

Lung Transplantation

“A Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Aerosolized ALN-RSV01 Plus Standard of Care in Lung Transplant Patients Infected with Respiratory Syncytial Virus (RSV)”
Principal Investigator: David Neujahr, MD

Islet Transplantation

“Islet Transplantation versus Standard Medical Therapy in Type 1 Diabetic Kidney Allograft Recipients” (CIT-06)
Principal Investigator: Christian Larsen, MD, DPhil

“Islet Transplantation in Type 1 Diabetes with LEA29Y (Belatacept) Maintenance Therapy” (CIT-04)
Principal Investigator: Christian Larsen, MD, DPhil

“Islet Transplanation in Type 1 Diabetes” (CIT-07)
Principal Investigator: Christian Larsen, MD, DPhil

“Collaborative Islet Transplant Registry”
Principal Investigator: Nicole Turgeon, MD

Hand Transplantation

“Hand Transplantation for the Reconstruction of Below Elbow Amputations”
Principal Investigator: Linda Cendales, MD

If you are interested in learning more about these or other Emory Transplant Center Clinical Research projects, please call the ETC Clinical Research Program at 404-712-1114 to speak with one of our research coordinators.