Kidney Transplantation in Patients With Sickle Cell Disease
The purpose of this research is to better characterize the components and mechanisms of the immune systems of persons with sickle cell disease who have had a kidney transplant and are immunosuppressed. If we can improve our scientific understanding of the fundamental mechanisms involved in patient outcomes, we can potentially maximize the benefits that we seek from transplantation in sickle cell patients with end stage renal disease.
Sickle Cell Disease
|Study Design:||Time Perspective: Prospective|
|Official Title:||Kidney Transplantation in Patients With Sickle Cell Disease|
- No measure applied [ Time Frame: 05/08/2008-6/05/2009 ] [ Designated as safety issue: No ]One 12 month participant, with no actions. One subject was a screen failure due to hepatitis C.
Biospecimen Retention: Samples With DNA
100 mLs of whole blood will be collected at designated time points. Baseline, and at 1,3,6,9,12,18 and 24 months post-transplant
|Study Start Date:||March 2008|
|Study Completion Date:||December 2010|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Sickle cell disease is a common disease in the African-American population. In sickle cell disease red blood cells are abnormal in shape and can damage organs. In particular, patients with sickle cell disease can have damage to the kidneys, resulting in renal failure. The number of patients developing renal failure with sickle cell disease is unknown. This is largely due to the high mortality of patients with sickle cell disease and renal failure.
There are two types of renal replacement therapy available to patients with sickle cell disease- dialysis and kidney transplantation. The best form of renal replacement therapy has not been determined for patients with sickle cell disease and renal failure. There have been approximately 190 renal transplants performed in the United States since 1988 in patients with sickle cell disease. Patients do well, but do not survive as long as patients with other causes of renal failure. It appears that patients with sickle cell disease who meet the criteria for kidney transplantation may derive a benefit from transplantation rather than undergoing dialysis.
We are performing this study to follow patients with sickle cell disease who have received a renal 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00663507
|United States, Georgia|
|Mason Outpatient Tranplant Clinic Emory University|
|Atlanta, Georgia, United States, 30302|
|Principal Investigator:||Nicole A Turgeon, M.D.||Emory University|