Sickle Cell Kidney Sample Bank

Sickle Cell Kidney (SCeK) Biorepository

This project will collect blood and urine from adults with sickle cell disease or sickle cell trait to see if linked samples and medical records can help researchers learn how kidney disease starts and progresses.

Quick facts

• Study type: Observational
• Enrollment: 800 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: University of Texas Southwestern Medical Center (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 2 sites (Dallas, Texas and 1 other locations)
• Trial ID: NCT07064174 on ClinicalTrials.gov

What this trial studies

Chronic kidney disease occurs early and more often in people with sickle cell disease and sickle cell trait, but the underlying causes and risk factors are not well understood. The SCeK Biorepository collects well-annotated blood and urine samples from consenting adults and links those samples to detailed clinical data. Stored samples can be re-tested with new laboratory methods to search for biomarkers, mechanisms, and predictors of kidney disease onset and progression. The repository is maintained by UT Southwestern and Parkland to support future research and development of tailored prevention or treatment strategies.

Who should consider this trial

Good fit: Ideal participants are adults (18–65 years) with a confirmed hemoglobinopathy (sickle cell disease or trait) and an eGFR ≥15 mL/min, with demographically matched controls without hemoglobinopathy considered selectively.

Not a fit: People on dialysis or with eGFR <15 mL/min, those 66 or older, active pregnant individuals, those with recent severe sickle pain requiring acute care, active induction cancer treatment, or prisoners are excluded and unlikely to receive direct benefit from participation.

Why it matters

Potential benefit: If successful, this could identify early markers and biological targets that help prevent or slow kidney disease in people with sickle cell disease or trait.

How similar studies have performed: Other disease-focused biorepositories have successfully produced biomarkers and mechanistic insights, though dedicated kidney-focused collections for sickle cell disease and trait are relatively limited so far.

Eligibility criteria

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.

Where this trial is running

Dallas, Texas and 1 other locations

• Parkland Memorial Hospital — Dallas, Texas, United States (Recruiting)
• University of Texas Southwestern Medical Center — Dallas, Texas, United States (Recruiting)

Study contacts

• Study coordinator: Kabir O Olaniran, MD, MPH, FASN

Conditions Sickle Cell Trait; Sickle Cell Disease; Chronic Kidney Disease