Status:
ACTIVE_NOT_RECRUITING
Kidney Function in Sickle Cell Anemia
Lead Sponsor:
Kenneth Ataga MD
Collaborating Sponsors:
Ohio State University
University of North Carolina
Conditions:
Sickle Cell Disease
Kidney Failure, Chronic
Eligibility:
All Genders
18-65 years
Brief Summary
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-ad...
Detailed Description
Sickle cell disease is a severe monogenic disorder which affects approximately 80,000 patients in the US. It is characterized by a vasculopathy with involvement of multiple organs and resulting in com...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 17 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT03277547
Start Date
November 17 2017
End Date
December 1 2025
Last Update
January 27 2025
Active Locations (3)
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1
University of North Carolina-Chapel Hill
Chapel Hill, North Carolina, United States, 27599
2
Ohio State Adult Sickle Cell Program
Columbus, Ohio, United States, 43210
3
UTHSC Center for Sickle Cell Disease
Memphis, Tennessee, United States, 38163