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NCT07064174RecruitingAccepts Healthy Volunteers

Sickle Cell Kidney Biorepository

University of Texas Southwestern Medical Center

Start Date

8/22/2024

Completion Date

12/1/2049

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.

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.

Eligibility Criteria

Age Range: 18 years to 65 years

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.

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Conditions

Sickle Cell TraitSickle Cell Disease (SCD)Chronic Kidney Disease

Locations

Parkland Memorial Hospital

Dallas, Texas 75235

United States

University of Texas Southwestern Medical Center

Dallas, Texas 75390

United States