Sickle Cell DiseaseNCT00663507
Kidney Transplantation in Patients With Sickle Cell Disease
An observational study of Sickle Cell Disease, run by Emory University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sickle Cell Disease
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Diagnosis of sickle cell disease (SS type) with end stage renal disease
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mason Outpatient Tranplant Clinic Emory University
Atlanta, Georgia, 30302
About this study
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.
- Conditions
- Sickle Cell Disease
- Keywords
- Sickle Cell Disease, Immunosuppression, Organ & Tissue Transplantation, Transplantation Immunology
- Medical subject headings
- Anemia, Sickle Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
No measure applied
One 12 month participant, with no actions. One subject was a screen failure due to hepatitis C.
Measured: 05/08/2008-6/05/2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionDec 2010
- Study completionDec 2010
Why it stopped: Only 1 patient was enrolled. No funding, small number of eligible patients so would not achieve statistical power.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicole Turgeon MD, Emory University
- Investigators
- Nicole A Turgeon, M.D., Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00663507
- Sponsor's protocol ID
- IRB00004914
- Status last verified
- Feb 2013
- First submitted
- 18 Apr 2008
- Last updated
- 27 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kidney Transplantation in Patients With Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT00663507
- Acronym / sponsor ID
- IRB00004914
- Conditions
- Sickle Cell Disease
- Keywords
- Sickle Cell Disease, Immunosuppression, Organ & Tissue Transplantation, Transplantation Immunology
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Only 1 patient was enrolled. No funding, small number of eligible patients so would not achieve statistical power.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 22 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diagnosis of sickle cell disease (SS type) with end stage renal disease
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study was stopped early (reason given: Only 1 patient was enrolled. No funding, small number of eligible patients so would not achieve statistical power.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicole A Turgeon, M.D. principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sickle Cell Disease, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Only 1 patient was enrolled. No funding, small number of eligible patients so would not achieve statistical power.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
No measure applied (time frame: 05/08/2008-6/05/2009). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2013.