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Sickle Cell Uric Acid (SCUA) - Cohort Repository

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04190888
Recruitment Status : Completed
First Posted : December 9, 2019
Last Update Posted : February 4, 2022
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University

Study Description
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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
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
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Study Type : Observational [Patient Registry]
Actual Enrollment : 78 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Sickle Cell Uric Acid (SCUA) - Cohort Repository
Actual Study Start Date : July 1, 2019
Actual Primary Completion Date : December 31, 2021
Actual Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Uric Acid

Groups and Cohorts
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Group/Cohort Intervention/treatment
Sickle Cell Disease
Patients with sickle cell disease will be followed prospectively
 Other: No intervention
No intervention - observational study


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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

  3. 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.


Biospecimen Retention:   Samples Without DNA
Urine and Serum samples will be stored in a research repository

Eligibility Criteria
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Ages Eligible for Study:   5 Years to 29 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants currently receiving medical care from the pediatric or adult hematology comprehensive sickle cell centers.
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04190888


Locations
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United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
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Principal Investigator: Cristin Kaspar, MD Virginia Commonwealth University
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT04190888    
Other Study ID Numbers: HM20016157
First Posted: December 9, 2019    Key Record Dates
Last Update Posted: February 4, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Virginia Commonwealth University:
Uric acid
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Anemia, Sickle Cell
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases
Renal Insufficiency
 Chronic Disease
Disease Attributes
Pathologic Processes
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn