Sickle Cell TraitSCeKNCT07064174
Sickle Cell Kidney Biorepository
An observational study of Sickle Cell Trait and Sickle Cell Disease (SCD), run by University of Texas Southwestern Medical Center at 2 sites in United States.
Trial summary
Kidney disease is a major cause of illness and death in people with sickle cell disease and sickle cell trait. Despite these concerning facts, we do not (1) have an in-depth understanding of how kidney disease starts in sickle cell disease and sickle cell trait, (2) have detailed insights into why kidney disease is… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sickle Cell Trait, Sickle Cell Disease (SCD), Chronic Kidney Disease
- How many people
- 800 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Aug 2024to Dec 2049
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants include all eligible adults who are able to provide samples at the primary study site(s). Health data and surveys can be completed electronically.
Who may be able to join
- Age over 18 years,
- Estimated glomerular filtration rate greater than or equal to 15 mL/min,
- Presence of any hemoglobinopathy (will need to be confirmed by hemoglobin electrophoresis or genetic testing),
- Controls (absence of hemoglobinopathy) will be subject to review and only selected if demographics are identical to a currently enrolled participant with a hemoglobinopathy.
Who cannot join
- Age 66 years or older,
- Estimated glomerular filtration rate less than 15 mL/min or on dialysis,
- Active pregnancy (may be enrolled 4 weeks or more after delivery),
- Active sickle cell pain episode requiring hospitalization or emergency room visit or pain infusion clinic visit (may be enrolled 2 weeks or more after resolution of severe pain),
- Active malignancy on induction or consolidation treatment. Maintenance chemotherapy in remission will be considered,
- Prisoners.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Parkland Memorial Hospital
Dallas, Texas, 75235
Kabir O Olaniran, MD, MPH, FASN, 214-645-8267, SCeK@UTSouthwestern.edu
Kabir O Olaniran, MD, MPH, FASN
- Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Kidney Clinical Research Office, 214-645-8267, SCeK@UTSouthwestern.edu
Kabir O Olaniran, MD, MPH, FASN
About this study
Official title: Sickle Cell Kidney (SCeK) Biorepository
Kidney disease is a major cause of illness and death in people with sickle cell disease and sickle cell trait. Despite these concerning facts, we do not (1) have an in-depth understanding of how kidney disease starts in sickle cell disease and sickle cell trait, (2) have detailed insights into why kidney disease is worse in people with sickle cell disease and sickle cell trait, (3) have management options that are tailored to treating or preventing kidney disease in people with sickle cell disease or sickle cell trait.
The SCeK Biorepository is a specialized, secure repository designed for the collection of blood and urine samples from people with sickle cell disease and sickle cell trait. These samples are connected to detailed medical records, with the sole purpose of allowing researchers to better understand how kidney disease starts and progresses in people with the sickle cell gene. By studying these stored samples (using new tests) together with health information, researchers can find better early warning signs of kidney injury and develop better ways to protect kidney health in people with sickle cell disease and sickle cell trait.
Read the detailed description
Chronic kidney disease is one of the most common causes of morbidity and mortality in sickle cell disease, occurring at a much earlier age and with a far higher frequency as compared to the general population. Furthermore, sickle cell trait has emerged as an under-recognized major risk factor for chronic kidney disease.
Despite the seriousness of these findings, there are significant gaps in our understanding of the pathophysiology of and risk factors for incident chronic kidney disease and chronic kidney disease progression in both sickle cell disease and sickle cell trait.
The UT Southwestern and Parkland Health Sickle Cell Kidney (SCeK) Biorepository aims to address these knowledge gaps by collecting well annotated, high quality dedicated bio-samples integrated with routine clinical data to facilitate improved prognostication, provide mechanistic insights, and form the basis for the investigation of novel therapeutic options.
- Medical subject headings
- Sickle Cell Trait, Anemia, Sickle Cell, Renal Insufficiency, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
Kidney function decline
Mean change in the estimated glomerular filtration rate per year
Measured: 10 years
Albuminuria
Mean change in the urine albumin-to-creatinine ratio per year
Measured: 10 years
Secondary outcomes (3)
Mortality
Time to death over follow up period
Measured: 10 years
Hospitalization rates
Frequency of hospitalizations and emergency room visits over follow up
Measured: 10 years
Cardiovascular outcomes
Incident left ventricular hypertrophy, diastolic dysfunction, heart failure, pulmonary hypertension, or stroke.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start22 Aug 2024
- Primary completionDec 2049 (estimated)
- Study completionDec 2049 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell TraitStudies of the same condition, open and under way.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kabir Olaniran, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07064174
- Sponsor's protocol ID
- STU-2022-1024
- Acronym
- SCeK
- Status last verified
- Apr 2026
- First submitted
- 2 Jul 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sickle Cell Kidney (SCeK) Biorepository
- ClinicalTrials.gov ID
- NCT07064174
- Acronym / sponsor ID
- SCeK / STU-2022-1024
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 22 Aug 2024 (actual)
- Primary completion
- Dec 2049 (estimated)
- Study completion
- Dec 2049 (estimated)
- First posted
- 14 Jul 2025 (actual)
- 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.
Kidney disease is a major cause of illness and death in people with sickle cell disease and sickle cell trait. Despite these concerning facts, we do not (1) have an in-depth understanding of how kidney disease starts in sickle cell disease and sickle cell trait, (2) have detailed insights into why kidney disease is worse in people with sickle cell disease and sickle cell trait, (3) have management options that are tailored to treating or preventing kidney disease in people with sickle cell disease or sickle cell trait.
The SCeK Biorepository is a specialized, secure repository designed for the collection of blood and urine samples from people with sickle cell disease and sickle cell trait. These samples are connected to detailed medical records, with the sole purpose of allowing researchers to better understand how kidney disease starts and progresses in people with the sickle cell gene. By studying these stored samples (using new tests) together with health information, researchers can find better early warning signs of kidney injury and develop better ways to protect kidney health in people with sickle cell disease and sickle cell trait.
Detailed description
Chronic kidney disease is one of the most common causes of morbidity and mortality in sickle cell disease, occurring at a much earlier age and with a far higher frequency as compared to the general population. Furthermore, sickle cell trait has emerged as an under-recognized major risk factor for chronic kidney disease.
Despite the seriousness of these findings, there are significant gaps in our understanding of the pathophysiology of and risk factors for incident chronic kidney disease and chronic kidney disease progression in both sickle cell disease and sickle cell trait.
The UT Southwestern and Parkland Health Sickle Cell Kidney (SCeK) Biorepository aims to address these knowledge gaps by collecting well annotated, high quality dedicated bio-samples integrated with routine clinical data to facilitate improved prognostication, provide mechanistic insights, and form the basis for the investigation of novel therapeutic options.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants include all eligible adults who are able to provide samples at the primary study site(s). Health data and surveys can be completed electronically.
Key inclusion criteria (4 listed)
- Age over 18 years,
- Estimated glomerular filtration rate greater than or equal to 15 mL/min,
- Presence of any hemoglobinopathy (will need to be confirmed by hemoglobin electrophoresis or genetic testing),
- Controls (absence of hemoglobinopathy) will be subject to review and only selected if demographics are identical to a currently enrolled participant with a hemoglobinopathy.
Key exclusion criteria (6 listed)
- Age 66 years or older,
- Estimated glomerular filtration rate less than 15 mL/min or on dialysis,
- Active pregnancy (may be enrolled 4 weeks or more after delivery),
- Active sickle cell pain episode requiring hospitalization or emergency room visit or pain infusion clinic visit (may be enrolled 2 weeks or more after resolution of severe pain),
- Active malignancy on induction or consolidation treatment. Maintenance chemotherapy in remission will be considered,
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
Kidney function decline
Time frame: 10 years
Mean change in the estimated glomerular filtration rate per year
Albuminuria
Time frame: 10 years
Mean change in the urine albumin-to-creatinine ratio per year
3 secondary outcomes
Mortality
Time frame: 10 years
Hospitalization rates
Time frame: 10 years
Cardiovascular outcomes
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: Yes
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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.
2 sites 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 Trait and Sickle Cell Disease (SCD), run by University of Texas Southwestern Medical Center at 2 sites 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 6 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: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kabir O Olaniran, MD, MPH, FASN (214-645-8267, SCeK@UTSouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kidney function decline (time frame: 10 years). The study lists 2 primary outcomes in all. 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 13 Apr 2026.