The Association of Biomarkers of Endothelial Function With Prospective Changes in Kidney Function in Sickle Cell Anemia

About the study

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”


3 United States sites


18 to 65 Years



Study type






participation requirements

1. age of 18 to 65 years;

2. confirmed diagnosis of sickle cell anemia (HbSS and SB0 thalassemia);

3. non-crisis, “steady state” with no severe pain episodes requiring medical contact
during the preceding 4 weeks;

4. ability to understand the requirements of the study and be willing to give informed

participation restrictions

1. bone marrow transplantation;

2. history of long-standing diabetes mellitus with suspicion for diabetic nephropathy as
determined by a nephrologist;

3. known diagnosis of hepatitis B or C infection (patients will not be screened
specifically for this during the study);

4. known HIV positive (patients will not be screened specifically for this);

5. history of cancer, except non-melanoma skin cancer;

6. pregnant or breastfeeding;

7. connective tissue disease such as SLE;

8. known glomerular disease unrelated to SCD;

9. patients with ESRD on chronic dialysis.


  • Chapel Hill, North Carolina, United States, University of North Carolina-Chapel Hill, 27599 [Recruiting]
  • Columbus, Ohio, United States, Ohio State Adult Sickle Cell Program, 43210 [Recruiting]
  • Memphis, Tennessee, United States, UTHSC Center for Sickle Cell Disease, 38163 [Recruiting]
Last updated 2021-06-11