Recruiting

Observational Study

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT07064174

Conditions

Sickle Cell Trait

Sickle Cell Disease (SCD)

Chronic Kidney Disease

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Study Details

Brief 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 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.

Conditions

Sickle Cell Trait

Sickle Cell Disease (SCD)

Chronic Kidney Disease

Study ID

NCT07064174

Start date

Aug 22, 2024

Status verified date

Apr, 2026

Completion date

Dec, 2049

Anticipated

Primary completion date

Dec, 2049

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Age over 18 years,
2. Estimated glomerular filtration rate greater than or equal to 15 mL/min,
3. Presence of any hemoglobinopathy (will need to be confirmed by hemoglobin electrophoresis or genetic testing),
4. Controls (absence of hemoglobinopathy) will be subject to review and only selected if demographics are identical to a currently enrolled participant with a hemoglobinopathy.

Exclusion Criteria:

1. Age 66 years or older,
2. Estimated glomerular filtration rate less than 15 mL/min or on dialysis,
3. Active pregnancy (may be enrolled 4 weeks or more after delivery),
4. 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),
5. Active malignancy on induction or consolidation treatment. Maintenance chemotherapy in remission will be considered,
6. Prisoners.

Study Design

Enrollment

800 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Kidney function decline [ Time Frame: 10 years ]
  • Albuminuria [ Time Frame: 10 years ]

Central Contacts and Locations

Central contacts

Kabir O Olaniran, MD, MPH, FASN

214-645-8267SCeK@UTSouthwestern.edu

Locations

Parkland Memorial Hospital

Recruiting

Dallas, Texas, United States, 75235

Contacts

Kabir O Olaniran, MD, MPH, FASN

214-645-8267SCeK@UTSouthwestern.edu

Principal Investigator:

Kabir O Olaniran, MD, MPH, FASN

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Kidney Clinical Research Office

214-645-8267SCeK@UTSouthwestern.edu

Principal Investigator:

Kabir O Olaniran, MD, MPH, FASN

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2026-04-13.