Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 48 for:    Sickle Cell Disease OR sickle cell anemia OR sickle cell disease OR hemoglobin S disease OR hemoglobin SS disease | Recruiting, Not yet recruiting, Available Studies | NIH, U.S. Fed

Best Noninvasive Predictor of Renal Function in Assessing Adult Sickle Nephropathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03958643
Recruitment Status : Recruiting
First Posted : May 22, 2019
Last Update Posted : June 20, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )

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.

...


Condition or disease
Sickle Cell Disease

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.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Best Noninvasive Predictor of Renal Function in Assessing Adult Sickle Nephropathy
Actual Study Start Date : May 24, 2019
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : May 1, 2021

Resource links provided by the National Library of Medicine


Group/Cohort
1
In a population of adult patients with SCD we will comprehensively evaluate renal function



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.@@@
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03958643


Contacts
Layout table for location contacts
Contact: Julia M Varga (301) 827-1396 julia.varga@nih.gov

Locations
Layout table for location information
United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Layout table for investigator information
Principal Investigator: Emily M Limerick, M.D. National Cancer Institute (NCI)

Additional Information:
Layout table for additonal information
Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT03958643     History of Changes
Other Study ID Numbers: 190100
19-H-0100
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: June 20, 2019
Last Verified: June 18, 2019

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) ):
Sickle Nephropathy
Iothalamate
Cystatin-C

Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Diseases
Anemia, Sickle Cell
Urologic Diseases
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn