Sickle Cell Kidney Biorepository

NCT07064174 | Recruiting

• 1 other identifier: STU-2022-1024
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (2)

• Kidney function decline

  Mean change in the estimated glomerular filtration rate per year

  10 years

• Albuminuria

  Mean change in the urine albumin-to-creatinine ratio per year

  10 years

Secondary Outcomes (3)

• Mortality

  10 years

• Hospitalization rates

  10 years

• Cardiovascular outcomes

  10 years

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (2)

Parkland Memorial Hospital

Dallas, Texas, 75235, United States

RECRUITING

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Serum, Plasma (lithium heparin and K2 EDTA), Citrate whole blood, K2EDTA Buffy coat, Urine supernatant, Urine sediment.

MeSH Terms

Conditions

Sickle Cell Trait; Anemia, Sickle Cell; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Kabir O Olaniran, MD, MPH, FASN

CONTACT

214-645-8267; SCeK@UTSouthwestern.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 14, 2025
• Study Start: August 22, 2024
• Primary Completion (Estimated): December 1, 2049
• Study Completion (Estimated): December 1, 2049
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: IPD will be available beginning 6 months after publication of the primary results and will remain available for up to 10 years.
• Access Criteria: Data will be shared with qualified researchers who provide a methodologically sound research proposal. Requests can be submitted to the study principal investigator by email. A data request portal will be added to the website in due course (www.utsouthwestern.edu/scek-study). Only researchers affiliated with academic, non-profit, or governmental institutions, pending data use agreement and ethical approval from their institutional review boards will be provided with data.

Locations

US (2)