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Best Noninvasive Predictor of Renal Function in Assessing Adult Sickle Nephropathy

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ClinicalTrials.gov Identifier: NCT03958643
Recruitment Status : Recruiting
First Posted : May 22, 2019
Last Update Posted : July 22, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )

Tracking Information
First Submitted Date May 21, 2019
First Posted Date May 22, 2019
Last Update Posted Date July 22, 2019
Actual Study Start Date May 24, 2019
Estimated Primary Completion Date May 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 21, 2019)
Determine whether serum cystatin C or serum creatinine- based GFR methods better estimate renal function in the adult sickle cell population [ Time Frame: 2 years ]
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03958643 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: May 21, 2019)
Determine whether endothelin- 1 or beta-2 microglobulin correlates with measured GFR (mGFR) [ Time Frame: 2 years ]
Determine whether endothelin- 1 or beta-2 microglobulin correlates with measured GFR (mGFR)-establish potential correlation between mGFR, endothelin-1, or beta-2 microglobulin and renal blood flow-characterize the proteinuria associated with sickle cell disease-characterize kidney anatomy in patients with sickle cell disease-ascertain if markers of hemolysis are associated with mGFR or renal iron deposition-quantify renal iron burden in-sickle cell disease
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Best Noninvasive Predictor of Renal Function in Assessing Adult Sickle Nephropathy
Official Title Best Noninvasive Predictor of Renal Function in Assessing Adult Sickle Nephropathy
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.

...

Detailed Description

The characteristic sickling of red blood cells in hypoxic conditions is the root cause of pathology in sickle cell disease (SCD). When this sickling occurs in the renal microvasculature, and is compounded by chronic vasculopathy related to hemolysis, the result is local infarction, ischemic injury, and interstitial fibrosis. The kidney damage begins in early childhood and is cumulative over time, resulting in sickle cell nephropathy (SCN). Creatinine clearance remains the most commonly used method to evaluate renal function in SCD patients although serum creatinine generally over-estimates the GFR in SCD. Cystatin-C (Cys-C) is freely filtered. Unlike creatinine, it is not secreted by the tubules. Its serum levels correlate with GFR in adults with various kidney diseases as well as in pediatric and adult SCD populations as compared with creatinine-based assessments.

This study seeks to evaluate whether Cys-C is a better noninvasive measure of renal function in the adult sickle cell population than creatinine. Further, this work will elucidate the ability of other markers, including beta 2-microglobulin (beta 2M) and endothelin-1 (ET-1), to predict sickle nephropathy. Finally, renal imaging by MRI will be performed and correlated with measured GFR and renal function markers. The results of this study could help alter clinical practice and thereby ensure the most accurate non-invasive assessment of kidney function by substantiating the role of Cys-C, beta 2M and ET-1 in adults with SCD. Finally, the descriptive analysis including measured GFR with renal MRI, novel biomarkers, markers of hemolysis, and analysis of urinary protein secretion will contribute to a better understanding of the pathophysiology of SCN.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The study will be open to all eligibile subjects based on in clusion 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.@@@
Condition Sickle Cell Disease
Intervention Not Provided
Study Groups/Cohorts 1
In a population of adult patients with SCD we will comprehensively evaluate renal function
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 21, 2019)
70
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 1, 2021
Estimated Primary Completion Date May 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria
  • INCLUSION CRITERIA:

Known diagnosis of Sickle Cell Anemia (Hemoglobin S/Beta-null thalassemia) >=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

Active inflammatory disease (e.g. gout, 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

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Julia M Varga (301) 827-1396 julia.varga@nih.gov
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03958643
Other Study ID Numbers 190100
19-H-0100
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
Study Sponsor National Heart, Lung, and Blood Institute (NHLBI)
Collaborators Not Provided
Investigators
Principal Investigator: Emily M Limerick, M.D. National Cancer Institute (NCI)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date July 18, 2019