Clinical Trials
Current research studies:
Use of Belatacept during Post Depletional Repopulation to Facilitate Tolerance in Renal Allograft Recipients (IM103-036)
This study tests the safety and effectiveness of a new investigational drug combination using the drugs alemtuzumab, belatacept and sirolimus when given with or without donor bone marrow. Alemtuzumab (Campath®) is approved for use in patients with certain types of white blood cell cancers but is considered investigational in transplant patients. Belatacept is an investigational drug being studied in kidney transplant patients. Sirolimus (Rapamune®) is approved for use in transplant patients, but its use with belatacept and alemtuzumab is investigational. In some patients enrolled on this trial, we will also test whether an infusion of bone marrow from the kidney donor will improve the effect of these drugs. Bone marrow infusion is considered investigational. This study is for people who are receiving their first kidney transplant from a living donor.
Immune Monitoring and Assay Development in Organ Transplant
The purpose of this study is to establish a library or "biorepository" of well characterized blood, urine and tissue samples from transplant patients. These samples will be stored in a research lab at Emory for use by Emory researchers. These samples will be tested using a variety of biological tests to better understand how immunosuppressive drugs affect the various components of the immune system.
Bariatric Surgery in Obese End Stage Renal Disease Patients
Obese patients with end stage kidney disease will be enrolled in this study over a five-year period. We hope to determine the safety and effectiveness of three weight lowering procedures in patients with kidney disease. Patients will undergo laparoscopic gastric banding, laparoscopic gastric bypass, or sleeve gastrectomy. Once a weight loss Body Mass Index (BMI) goal of 35 has been achieved, patients will then be considered for placement on the kidney transplant waiting list. The purpose of this study is to determine if it is safe to perform weight lowering procedures in patients with renal failure. We hope to allow more patients safer access to kidney transplant.
Kidney Transplantation in Patients with Sickle Cell Disease
We are performing this study to follow patients with sickle cell disease who receive a kidney transplant. We hope to learn the best way to manage patients with sickle cell disease to improve both survival of the transplanted kidney and the patients. In addition, we are studying the immune system and how it responds to receiving a kidney transplant in sickle cell patients. We hope the information we learn about the immune system will allow us to prevent injury to the new kidney transplant and allow for better outcomes in sickle cell patients.
Following are some of the recent clinical trials our patients have participated in (no longer open for enrollment):
BENEFIT BMS (IM103-008)
This study examines treatment with an investigational drug called Belatacept as compared with cyclosporine. Patients receiving a kidney from a living or deceased donor were randomized to receive the investigational drug, Belatacept, given monthly by IV infusion, or cyclosporine (Neoral®).
BENEFIT-EXT (BMS IM103-027)
This study was for patients who received their first kidney transplant from a deceased donor who met certain criteria to be an ‘expanded criteria donor'. The participant was randomized receive either standard post- transplant medications or the investigational drug, Belatacept .
CTOT-01: Non-invasive Monitoring in Kidney Transplant
This study was for patients who received their first kidney transplant from either deceased or living donors. Blood and urine samples were collected at specific time points both before and after the transplant. Kidney biopsy samples were collected at 6 months after transplant. These samples have been sent to research laboratories for novel testing to see if there are biologic markers of immune activity that predict acute rejection or kidney injury.
PIP-01: The Impact of Chronic Immunosuppression on Protective Immunity
This study is examining whether there are unique differences in the immune system as a result of the different immunosuppression medications we currently use in kidney transplant. Blood samples are drawn at 6 time points over a two year period to monitor the different cells of the immune system over time.
PIP-02: Characterization of the Immune Response to Flu Vaccine in Kidney Transplant Recipients compared to Healthy Controls
In this study, researchers are looking at how kidney transplant patients' immune systems respond to the flu vaccine and comparing that response to the immune response of healthy volunteers.
If you are interested in learning more about research, please contact the
Emory Transplant Center Clinical Research Program at 404-712-1114.
