Sickle Cell Kidney Biorepository
Recruiting · NCT07064174 · Observational (researchers observe without assigning treatment) · Lead sponsor: University of Texas Southwestern Medical Center
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Where it is running
2 locations listed across 1 US state.
- Parkland Memorial Hospital - Dallas, Texas, United States
- University of Texas Southwestern Medical Center - Dallas, Texas, United States