Active — Not RecruitingNot Applicable

Kidney Function in Sickle Cell Anemia

United States300 participantsStarted 2017-11-17

Plain-language 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-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 participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 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;

What they're measuring

Age- and sex-adjusted rate of change, over 36 - 48 months, in estimated glomerular filtration rate in patients with sickle cell anemia

Timeframe: 36-48 months

Age- and sex-adjusted rate of change, over 36 - 48 months, in albuminuria in patients with sickle cell anemia

Timeframe: 36-48 months

Cross-sectional association of biomarkers of endothelial function with kidney function (estimated glomerular filtration rate and albuminuria) in patients with sickle cell anemia

Timeframe: 36-48 months

Cross-sectional association of urine and plasma metabolomics profiles with kidney function (estimated glomerular filtration rates and albuminuria) in patients with sickle cell anemia

Timeframe: 36-48 months

Trial details

NCT IDNCT03277547

SponsorKenneth Ataga MD

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-06-01

View on ClinicalTrials.gov More Sickle Cell Disease trials

Plain-language summary

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 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;

What they're measuring

Age- and sex-adjusted rate of change, over 36 - 48 months, in estimated glomerular filtration rate in patients with sickle cell anemia

Timeframe: 36-48 months

Age- and sex-adjusted rate of change, over 36 - 48 months, in albuminuria in patients with sickle cell anemia

Timeframe: 36-48 months

Cross-sectional association of biomarkers of endothelial function with kidney function (estimated glomerular filtration rate and albuminuria) in patients with sickle cell anemia

Timeframe: 36-48 months

Cross-sectional association of urine and plasma metabolomics profiles with kidney function (estimated glomerular filtration rates and albuminuria) in patients with sickle cell anemia

Timeframe: 36-48 months