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Kidney Transplantation in Patients With Sickle Cell Disease

This study has been terminated.
(Only 1 patient was enrolled. No funding, small number of eligible patients so would not achieve statistical power.)
Sponsor:
Information provided by (Responsible Party):
Nicole Turgeon MD, Emory University
ClinicalTrials.gov Identifier:
NCT00663507
First received: April 18, 2008
Last updated: February 25, 2013
Last verified: February 2013
History of Changes
  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

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Kidney Transplantation in Patients With Sickle Cell Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Emory University:

Primary Outcome Measures:
  • 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


Enrollment: 2
Study Start Date: March 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (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 65 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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00663507

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

No publications provided

Responsible Party: Nicole Turgeon MD, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT00663507     History of Changes
Other Study ID Numbers: IRB00004914
Study First Received: April 18, 2008
Last Updated: February 25, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 23, 2013