Sickle Cell Uric Acid (SCUA) - Cohort Repository

Sponsor

Virginia Commonwealth University (Other)

Overall Status

Completed

CT.gov ID

NCT04190888

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Kidney Diseases Sickle Cell Disease	Other: No intervention

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 Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

78 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Sickle Cell Uric Acid (SCUA) - Cohort Repository

Actual Study Start Date :

Jul 1, 2019

Actual Primary Completion Date :

Dec 31, 2021

Actual Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Sickle Cell Disease Patients with sickle cell disease will be followed prospectively	Other: No intervention No intervention - observational study

Arm

Intervention/Treatment

Sickle Cell Disease

Patients with sickle cell disease will be followed prospectively

Other: No intervention

No intervention - observational study

Outcome Measures

Primary Outcome Measures

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.
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
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 29 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Virginia Commonwealth University	Richmond	Virginia	United States	23298

Sponsors and Collaborators

Virginia Commonwealth University

Investigators

Principal Investigator: Cristin Kaspar, MD, Virginia Commonwealth University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Virginia Commonwealth University

ClinicalTrials.gov Identifier:

NCT04190888

Other Study ID Numbers:

HM20016157

First Posted:

Dec 9, 2019

Last Update Posted:

Feb 4, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Virginia Commonwealth University

Uric acid

Additional relevant MeSH terms:

Kidney Diseases

Renal Insufficiency, Chronic

Anemia, Sickle Cell

Study Results

No Results Posted as of Feb 4, 2022