Kidney Transplantation in Patients With Sickle Cell Disease

NCT00663507 | Terminated DMC

• 1 other identifier: IRB00004914
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Sickle Cell Disease

Keywords

Sickle Cell Disease; Immunosuppression; Organ & Tissue Transplantation; Transplantation Immunology

Outcome Measures

Primary Outcomes (1)

• No measure applied

  One 12 month participant, with no actions. One subject was a screen failure due to hepatitis C.

  05/08/2008-6/05/2009

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Male or female patients between 18 and 65 years of age
• 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.
• Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to enrollment and must not be breast-feeding.
• Patients must be diagnosed with Sickle Cell Disease (SS phenotype)

You may not qualify if:

• Patients with any prior organ transplant or multi-organ transplant recipients.
• 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.
• Patients with history of malignancy in the last 5 years (except successfully treated localized non-melanotic skin cancer)
• Patients with active illegal drug use

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Mason Outpatient Tranplant Clinic Emory University

Atlanta, Georgia, 30302, United States

Location

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

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Nicole A Turgeon, M.D.

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 18, 2008
• First Posted: April 22, 2008
• Study Start: March 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: February 27, 2013

Record last verified: 2013-02

Locations

US (1)