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NCT04190888 Clinical Trial

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
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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