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Sickle Cell Uric Acid (SCUA) - Cohort Repository

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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

Tracking Information
First Submitted Date December 5, 2019
First Posted Date December 9, 2019
Last Update Posted Date February 4, 2022
Actual Study Start Date July 1, 2019
Actual Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 6, 2019)
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Sickle Cell Uric Acid (SCUA) - Cohort Repository
Official Title Sickle Cell Uric Acid (SCUA) - Cohort Repository
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.
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 Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 3 Years
Biospecimen Retention:   Samples Without DNA
Description:
Urine and Serum samples will be stored in a research repository
Sampling Method Non-Probability Sample
Study Population Participants currently receiving medical care from the pediatric or adult hematology comprehensive sickle cell centers.
Condition
  • Chronic Kidney Diseases
  • Sickle Cell Disease
Intervention Other: No intervention
No intervention - observational study
Study Groups/Cohorts Sickle Cell Disease
Patients with sickle cell disease will be followed prospectively
Intervention: Other: No intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 21, 2022)		 78
Original Estimated Enrollment
 (submitted: December 6, 2019)		 250
Actual Study Completion Date December 31, 2021
Actual Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 5 Years to 29 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04190888
Other Study ID Numbers HM20016157
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Current Responsible Party Virginia Commonwealth University
Original Responsible Party Same as current
Current Study Sponsor Virginia Commonwealth University
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Cristin Kaspar, MD Virginia Commonwealth University
PRS Account Virginia Commonwealth University
Verification Date January 2022