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Kidney Transplantation in Patients With Sickle Cell Disease
This study is currently recruiting participants.
Verified by Emory University, April 2008
Sponsored by: Emory University
Information provided by: Emory University
ClinicalTrials.gov Identifier: NCT00663507
  Purpose

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
Sickle Cell Disease

Genetics Home Reference related topics: sickle cell disease
MedlinePlus related topics: Kidney Transplantation Sickle Cell Anemia
U.S. FDA Resources
Study Type: Observational
Study Design: Prospective
Official Title: Kidney Transplantation in Patients With Sickle Cell Disease

Further study details as provided by Emory University:

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

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)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Diagnosis of sickle cell disease (SS type) with end stage renal disease

Criteria

Inclusion Criteria:

  1. Male or female patients between 18 and 55 years of age
  2. Patients capable of understanding the purposes and risks of the study, who can give written informed consent and who are willing to participate in and comply with the study.
  3. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to enrollment and must not be breast-feeding.
  4. Patients must be diagnosed with Sickle Cell Disease (SS phenotype)

Exclusion Criteria:

  1. Patients with any prior organ transplant or multi-organ transplant recipients.
  2. Patients with evidence of an active systemic infection requiring the continued use of antibiotics, evidence of an HIV infection, or the presence of a chronic active hepatitis B or C.
  3. Patients with history of malignancy in the last 5 years (except successfully treated localized non-melanotic skin cancer)
  4. Patients with active illegal drug use
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00663507

Contacts
Contact: Rivka S Elbein, BSN 404-712-4117 rivka.elbein@emoryhealthcare.org
Contact: Beth B Begley, BSN 404-712-7168 beth.begley@emoryhealthcare.org

Locations
United States, Georgia
Mason Outpatient Tranplant Clinic Emory University Recruiting
Atlanta, Georgia, United States, 30302
Principal Investigator: Nicole A Turgeon, M.D.            
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Nicole A Turgeon, M.D. Emory University
  More Information

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

Keywords provided by Emory University:
Sickle Cell Disease
Immunosuppression
Organ & Tissue Transplantation
Transplantation Immunology

Study placed in the following topic categories:
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn
Hematologic Diseases
Hemoglobinopathies
Anemia
Anemia, Hemolytic
Hemoglobinopathy
Anemia, Sickle Cell
Sickle cell anemia

ClinicalTrials.gov processed this record on January 16, 2009