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”

Locations

3 United States sites

Age

18 Years - 65 Years

Genotypes

HbSS

Study type

Observational

Gender

All

participation requirements

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.

participation restrictions

bone marrow transplantation;
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;
pregnant or breastfeeding;
connective tissue disease such as SLE;
known glomerular disease unrelated to SCD;
patients with ESRD on chronic dialysis.

Locations

  • 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