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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 : Enrolling by invitation
First Posted : December 9, 2019
Last Update Posted : December 9, 2019
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Sickle Cell Uric Acid (SCUA) - Cohort Repository
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : October 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Uric Acid

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




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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

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

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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: December 9, 2019
Last Verified: December 2019
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
Renal Insufficiency
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Uric Acid
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs