CClinicalTrials.gg
TerminatedNCT00663507Updated Feb 27, 2013

Kidney Transplantation in Patients With Sickle Cell Disease

An observational study in Sickle Cell Disease, sponsored by Emory University. Terminated at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-02-27.

Sponsored by Emory University · Observational

Why this study was terminated
Only 1 patient was enrolled. No funding, small number of eligible patients so would not achieve statistical power.
Study type
Observational
Time perspective
Prospective
Enrollment
2
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Sickle Cell Disease

Browse trials for

Keywords

  • Sickle Cell Disease
  • Immunosuppression
  • Organ & Tissue Transplantation
  • Transplantation Immunology
03

In context

Anemia, Sickle Cell

1,103 studies on the registry are indexed under Anemia, Sickle Cell; 235 are open to participants now.

This study's enrollment of 2 is below the median of 100 across 287 observational studies indexed under Anemia, Sickle Cell.

Browse Anemia, Sickle Cell studies →

Lead sponsor

Emory University is the lead sponsor of 1,386 studies on the registry; 236 are open to participants now.

Of its 229 completed or terminated interventional studies of FDA-regulated products, 174 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
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

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
05

Study design

Time perspective
Prospective
Enrollment
2 participants (actual)
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. No measure applied

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

    Time frame: 05/08/2008-6/05/2009

07

Study locations

1 site
  • Mason Outpatient Tranplant Clinic Emory University
    Atlanta, Georgia 30302, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 27, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00663507
Lead sponsor
Emory University
Responsible party
Nicole Turgeon MD (Assistant Professor, Emory University) — Principal investigator
First posted
Apr 22, 2008
Start date
Mar 2008
Primary completion
Dec 2010
Completion
Dec 2010
Last update
Feb 27, 2013

Study contacts

Nicole A Turgeon, M.D.
principal investigator · Emory University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion