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Kidney Transplantation in Patients With Sickle Cell Disease

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ClinicalTrials.gov Identifier: NCT00663507
Recruitment Status : Terminated (Only 1 patient was enrolled. No funding, small number of eligible patients so would not achieve statistical power.)
First Posted : April 22, 2008
Last Update Posted : February 27, 2013
Information provided by (Responsible Party):
Nicole Turgeon MD, Emory University

Brief Summary:
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 or disease
Sickle Cell Disease

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.

Study Type : Observational
Actual Enrollment : 2 participants
Time Perspective: Prospective
Official Title: Kidney Transplantation in Patients With Sickle Cell Disease
Study Start Date : March 2008
Primary Completion Date : December 2010
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. No measure applied [ Time Frame: 05/08/2008-6/05/2009 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Diagnosis of sickle cell disease (SS type) with end stage renal disease

Inclusion Criteria:

  1. Male or female patients between 18 and 65 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00663507

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

Responsible Party: Nicole Turgeon MD, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT00663507     History of Changes
Other Study ID Numbers: IRB00004914
First Posted: April 22, 2008    Key Record Dates
Last Update Posted: February 27, 2013
Last Verified: February 2013

Keywords provided by Nicole Turgeon MD, Emory University:
Sickle Cell Disease
Organ & Tissue Transplantation
Transplantation Immunology

Additional relevant MeSH terms:
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Hematologic Diseases
Genetic Diseases, Inborn