Sickle Cell Uric Acid (SCUA) - Cohort Repository

Sickle Cell Disease Clinical Trial

Official title:

Sickle Cell Uric Acid (SCUA) - Cohort Repository

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04190888
• Other study ID #: HM20016157
• Status: Completed
• Start date: July 1, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: January 2022
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 29 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic
• Sickle Cell Disease

Intervention

Other:
• No intervention
No intervention - observational study

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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