CompletedNot Applicable

Best Noninvasive Predictor of Renal Function in Assessing Adult Sickle Nephropathy

United States70 participantsStarted 2019-05-24

Plain-language 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. ...

Who can participate

Age range

18 Years

Sex

ALL

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: 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 2 years

Trial details

NCT IDNCT03958643

SponsorNational Heart, Lung, and Blood Institute (NHLBI)

Sponsor typeNIH

Study typeOBSERVATIONAL

Primary completion2021-05-01

View on ClinicalTrials.gov More Sickle Cell Disease trials