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Sponsored by: |
Emory University |
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Information provided by: | Emory University |
ClinicalTrials.gov Identifier: | NCT00663507 |
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.
Condition |
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Sickle Cell Disease |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | Kidney Transplantation in Patients With Sickle Cell Disease |
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
Estimated Enrollment: | 50 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | March 2012 |
Estimated Primary Completion Date: | March 2011 (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.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Diagnosis of sickle cell disease (SS type) with end stage renal disease
Inclusion Criteria:
Exclusion Criteria:
Contact: Rivka S Elbein, BSN | 404-712-4117 | rivka.elbein@emoryhealthcare.org |
Contact: Beth B Begley, BSN | 404-712-7168 | beth.begley@emoryhealthcare.org |
United States, Georgia | |
Mason Outpatient Tranplant Clinic Emory University | Recruiting |
Atlanta, Georgia, United States, 30302 | |
Principal Investigator: Nicole A Turgeon, M.D. |
Principal Investigator: | Nicole A Turgeon, M.D. | Emory University |
Responsible Party: | Emory University ( Nicole Turgeon, MD ) |
Study ID Numbers: | IRB00004914 |
Study First Received: | April 18, 2008 |
Last Updated: | April 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00663507 |
Health Authority: | United States: Institutional Review Board |
Sickle Cell Disease Immunosuppression Organ & Tissue Transplantation Transplantation Immunology |
Anemia, Hemolytic, Congenital Genetic Diseases, Inborn Hematologic Diseases Hemoglobinopathies Anemia |
Anemia, Hemolytic Hemoglobinopathy Anemia, Sickle Cell Sickle cell anemia |