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Protocol Details

Best Noninvasive Predictor of Renal Function in Assessing Adult Sickle Nephropathy

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

19-H-0100

Sponsoring Institute

National Heart, Lung and Blood Institute (NHLBI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18
Max Age: 99

Referral Letter Required

No

Population Exclusion(s)

Neonates;
Pregnant Women and Fetuses;
Children

Special Instructions

Currently Not Provided

Keywords

Sickle Nephropathy;
Iothalamate;
Cystatin-C

Recruitment Keyword(s)

None

Condition(s)

Sickle Cell Disease

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Heart, Lung, and Blood Institute

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.

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Eligibility

INCLUSION CRITERIA:

Known diagnosis of Sickle Cell Anemia (Hb SS or HbS-beta0-thal) >=18 years of age

Willingness and capacity to provide written informed consent

EXCLUSION CRITERIA:

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

Pain crisis in preceding 4weeks


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Emily M. Limerick, M.D.
National Cancer Institute (NCI)



Julia M. Varga
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room 6-5140
10 Center Drive
Bethesda, Maryland 20892
(301) 402-3595
julia.varga@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT03958643

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