Sickle Cell Uric Acid (SCUA) - Cohort R… | Clinical Trial

Key information

Conditions

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

Age range

5 year–29 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

No intervention - observational study

Primary outcomes

Percentage of participants in the sample with hyperuricemia

Time frame: Baseline

(i.e. high uric acid levels) out of all patients with a uric acid level measured at baseline.
Incidence rate of hyperuricemia per year

Time frame: Baseline to year 5

Calculate the incidence rate of new cases of hyperuricemia per year in each year of the cohort study
The mean rate of change of estimated glomerular filtration rate (eGFR) per year in those with hyperuricemia and those with normouricemia

Time frame: Baseline to year 5

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

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Registry information

Important dates

Study start: 2019
Primary completion: 2021
Study completion: 2021
First posted: Dec 9, 2019
Registry last updated: Feb 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed