Chronic Kidney DiseasesNCT04190888
Sickle Cell Uric Acid (SCUA) - Cohort Repository
An observational study of Chronic Kidney Diseases and Sickle Cell Disease, run by Virginia Commonwealth University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 29 years
- Conditions the study is for
- Chronic Kidney Diseases, Sickle Cell Disease
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2019to 31 Dec 2021
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 29 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Participants currently receiving medical care from the pediatric or adult hematology comprehensive sickle cell centers.
Who may be able to join
- 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.
Who cannot join
- Those who have received organ, stem cell, or bone marrow transplantation. - Those who require chronic dialysis
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
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.
Read the 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.
- Conditions
- Chronic Kidney Diseases, Sickle Cell Disease
- Being tested
- No intervention
- Keywords
- Uric acid
- Medical subject headings
- Renal Insufficiency, Chronic, Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention - observational study
| Study group | Role | What they receive |
|---|---|---|
| Sickle Cell Disease | Patients with sickle cell disease will be followed prospectively Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants in the sample with hyperuricemia
(i.e. high uric acid levels) out of all patients with a uric acid level measured at baseline.
Measured: Baseline
Incidence rate of hyperuricemia per year
Calculate the incidence rate of new cases of hyperuricemia per year in each year of the cohort study
Measured: Baseline to year 5
The mean rate of change of estimated glomerular filtration rate (eGFR) per year in those with hyperuricemia and those with normouricemia
Determine the mean rate of change of eGFR per year for each group.
Measured: Baseline to year 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2019
- Study start1 Jul 2019
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 78 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cristin Kaspar, MD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04190888
- Sponsor's protocol ID
- HM20016157
- Status last verified
- Jan 2022
- First submitted
- 5 Dec 2019
- Last updated
- 4 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sickle Cell Uric Acid (SCUA) - Cohort Repository
- ClinicalTrials.gov ID
- NCT04190888
- Acronym / sponsor ID
- HM20016157
- Conditions
- Chronic Kidney Diseases, Sickle Cell Disease
- Keywords
- Uric acid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 9 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sickle Cell Disease | – | Other: No interventionPatients with sickle cell disease will be followed prospectively |
Who may qualify
- Ages
- 5 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Participants currently receiving medical care from the pediatric or adult hematology comprehensive sickle cell centers.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Those who have received organ, stem cell, or bone marrow transplantation. - Those who require chronic dialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention - observational study | Other | Sickle Cell Disease |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2022.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cristin Kaspar, MD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Diseases and Sickle Cell Disease, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants in the sample with hyperuricemia (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2022.