Sickle Cell Uric Acid (SCUA) - Cohort Repository

Completed

• Conditions: Sickle Cell Disease; Chronic Kidney Diseases
• Interventions: Other: No intervention

• Registration Number: NCT04190888
• Lead Sponsor: Virginia Commonwealth University

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.

Detailed Description

Sickle Cell Disease causes kidney injury over time, but it is not clear why some individuals have very significant chronic kidney disease and why some do not. The purpose of this research is to study whether having high levels of 'uric acid,' which is a naturally occurring molecule in the body that may increase kidney injury and systemic inflammation, accelerates the progression of chronic kidney disease over time. Researchers will measure the number of participants that have high uric acid levels at the beginning of the study, as well as the number of participants that develop new high levels throughout the study. The study will also try to determine what causes the high uric acid levels in some patients but not others. The results of this study could help understand kidney injury and uric acid in sickle cell disease better.

Study Timeline

• Study Start: 2019-07-01
• Study First Submitted: 2019-12-05
• Study First Submitted QC: 2019-12-06
• Study First Posted: 2019-12-09
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-21
• Last Update Posted: 2022-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

• 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.

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sickle Cell Disease	No intervention	Patients with sickle cell disease will be followed prospectively

Primary Outcome Measures

Name	Time	Method
Incidence rate of hyperuricemia per year	Baseline to year 5	Calculate the incidence rate of new cases of hyperuricemia per year in each year of the cohort study
Percentage of participants in the sample with hyperuricemia	Baseline	(i.e. high uric acid levels) out of all patients with a uric acid level measured at baseline.
The mean rate of change of estimated glomerular filtration rate (eGFR) per year in those with hyperuricemia and those with normouricemia	Baseline to year 5	Determine the mean rate of change of eGFR per year for each group.

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States