Sickle Cell Uric Acid (SCUA) - Cohort Repository

NCT04190888 | Completed

• 1 other identifier: HM20016157
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to study the causes of Sickle Cell kidney disease, as well as to collect and store samples and information about people with Sickle Cell Disease.

Conditions

Chronic Kidney Diseases; Sickle Cell Disease

Keywords

Uric acid

Outcome Measures

Primary Outcomes (3)

• Percentage of participants in the sample with hyperuricemia

  (i.e. high uric acid levels) out of all patients with a uric acid level measured at baseline.

  Baseline

• Incidence rate of hyperuricemia per year

  Calculate the incidence rate of new cases of hyperuricemia per year in each year of the cohort study

  Baseline to year 5

• The mean rate of change of estimated glomerular filtration rate (eGFR) per year in those with hyperuricemia and those with normouricemia

  Determine the mean rate of change of eGFR per year for each group.

  Baseline to year 5

Study Arms (1)

Sickle Cell Disease

Patients with sickle cell disease will be followed prospectively

Other: No intervention

Interventions

No intervention OTHER

No intervention - observational study

Sickle Cell Disease

Eligibility Criteria

• Age: 5 Years - 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants currently receiving medical care from the pediatric or adult hematology comprehensive sickle cell centers.

You may qualify if:

• Age 5-29 years
• Sickle cell disease as diagnosed by hemoglobin electrophoresis, or by newborn screen per standard of care
• Currently receiving comprehensive sickle cell care at the Children's Hospital of Richmond at VCU or in the adult Internal Medicine sickle cell care clinic at VCU.

You may not qualify if:

• Those who have received organ, stem cell, or bone marrow transplantation. - Those who require chronic dialysis

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine and Serum samples will be stored in a research repository

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

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; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Cristin Kaspar, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2019
• First Posted: December 9, 2019
• Study Start: July 1, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: February 4, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)