🏛️ Verified NIH Record • Updated 2025-01-22

Kidney Function in Sickle Cell Anemia (NCT03277547)

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

🔵 Active, Not Recruiting Interventional Protocol 📊 Observational Clinical Research Sponsor: Kenneth Ataga MD

🩺 Plain-English Summary (8th-Grade Level)

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"

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (10 items).

Location: University of North Carolina-Chapel Hill — Chapel Hill, North Carolina

Age range: 18 Years to 65 Years

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • 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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (3 Sites)

  • University of North Carolina-Chapel Hill — Chapel Hill, North Carolina
  • Ohio State Adult Sickle Cell Program — Columbus, Ohio
  • UTHSC Center for Sickle Cell Disease — Memphis, Tennessee

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗