NCT03277547Active, not recruiting
Kidney Function in Sickle Cell Anemia
The Association of Biomarkers of Endothelial Function With Prospective Changes in Kidney Function in Sickle Cell Anemia
Source: ClinicalTrials.gov · Last updated 27 Jan 2025
Brief summary (registry, in English)
This is a prospective clinical cohort study that involves a baseline study visit followed by up to 3 annual follow-up study visits for a total follow-up of 36-48 months to evaluate the age- and sex-adjusted rate of change in kidney function, and to identify biomarkers of endothelial function, metabolomic profiles and clinical characteristics for the worsening of kidney function and for a rapid decline in kidney function. "Funding Source - FDA OOPD"
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 300 (estimated)
- First submitted
- 1 Sept 2017
- Start date
- 17 Nov 2017
- Primary completion date
- 1 Jun 2025
- Lead sponsor
- Kenneth Ataga MD
- Diseases
- Sickle cell disease
- NCT number
- NCT03277547
What you commit to
- Study type: Observational
- Planned participants: 300
- From 17 Nov 2017 to the primary completion date, 1 Jun 2025
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- bone marrow transplantation;
Other illness
- history of long-standing diabetes mellitus with suspicion for diabetic nephropathy as determined by a nephrologist;
- known diagnosis of hepatitis B or C infection (patients will not be screened specifically for this during the study);
- known HIV positive (patients will not be screened specifically for this);
- history of cancer, except non-melanoma skin cancer;
- connective tissue disease such as SLE;
- known glomerular disease unrelated to SCD;
Other
- pregnant or breastfeeding;
- patients with ESRD on chronic dialysis.
Who the study is looking for
- age of 18 to 65 years;
- confirmed diagnosis of sickle cell anemia (HbSS and SB0 thalassemia);
- non-crisis, "steady state" with no severe pain episodes requiring medical contact during the preceding 4 weeks;
- ability to understand the requirements of the study and be willing to give informed consent.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of North Carolina, Chapel Hill Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
| Ohio State Adult Sickle Cell Program Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| UTHSC Center for Sickle Cell Disease Coordinator of this site? Confirm its status | Memphis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.