Best Noninvasive Predictor of Renal Function in Assessing Adult Sickle Nephropathy

NCT03958643 | Completed

• 2 other identifiers: 19010019-H-0100
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Sickle cell disease is a common inherited blood disorder. Kidney disease is a major cause of problems in people with sickle cell disease. In order to identify kidney problems early and stop the progression of kidney disease, doctors need the most accurate tests to check kidney function. Researchers hope to understand more about how to test for kidney disease in people with sickle cell disease. Objective: To determine which of two different lab tests is the best to measure kidney function in adults with sickle cell disease. Eligibility: People 18 years and older who have sickle cell disease Design: Participants will be screened with a medical history and blood tests. Participants will have up to 3 visits. Participants will collect their urine in a special container over 24 hours. At the first visit, participants will have blood tests. They will bring their container of urine to the visit. They will have an iothalamate test. For the test, they will get a catheter: a small tube will be inserted into a vein. A special contract agent will be injected into the vein. Blood will be collected over the next 4 hours to test kidney function. Participants will return the next day for a second visit. They will have blood tests. They will have an MRI. For the MRI, they will like on a table that slides into a machine that takes pictures of the kidneys. They may have the MRI in a third visit. ...

Conditions

Sickle Cell Disease

Keywords

Sickle Nephropathy; Iothalamate; Cystatin-C; Natural History

Outcome Measures

Primary Outcomes (1)

• Determine whether serum cystatin C or serum creatinine-based GFR methods better estimate renal function in the adult sickle cell population

  In a population of patients with sickle cell anemia (including HbSS, HbS-0 thalassemia), who are age 18 and above, we will comprehensively evaluate renal function with the following primary objective:-determine whether serum cystatin C or serum creatinine- based GFR methods better estimate renal function in the adult sickle cell population

  2 years

Secondary Outcomes (1)

• Determine whether endothelin-1 or beta-2 microglobulin correlates with measured GFR (mGFR)

  2 years

Study Arms (1)

1

In a population of adult patients with SCD we will comprehensively evaluate renal function.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will be open to all eligible subjects based on inclusion and exclusion criteria and who provide informed consent. No patient will be excluded from participation based on gender, race, or ethnicity. Patients may self-refer, be recruited through the NIH office of recruitment, and may include patients participating on NIH Clinical Center Protocols, and NIH employees.

You may qualify if:

• Known diagnosis of Sickle Cell Anemia (Hb SS or HbS-beta0-thal) \>=18 years of age
• Willingness and capacity to provide written informed consent

You may not qualify if:

• Pregnancy
• Uncontrolled/poorly controlled hypertension
• Diabetes
• Dialysis
• GFR \<30 ml/min/1.73m2
• HIV positive
• HepatitisC
• Hepatitis B
• Prior transplantation
• Uncontrolled infection or acute illness
• Chronic inflammatory disease (e.g. lupus, multiple sclerosis, rheumatoid arthritis)
• Allergy to iodine or iodinated contrast solutions
• Hydroxyurea initiation or dose adjustment \<2mo prior
• Initiation of chronic transfusion therapy \<2mo prior
• Antihypertensive medication initiation or dose adjustment \<1mo prior

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Courtney F Joseph, M.D.

  National Heart, Lung, and Blood Institute (NHLBI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2019
• First Posted: May 22, 2019
• Study Start: May 24, 2019
• Primary Completion: May 1, 2021
• Study Completion: February 8, 2022
• Last Updated: January 21, 2026

Record last verified: 2026-01-13

Locations

US (1)