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Improving Scientific Rigor of Renal Clinical Endpoints for Sickle Cell Anemia

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: NCT04380610
Recruitment Status : Recruiting
First Posted : May 8, 2020
Last Update Posted : April 26, 2023
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Jeffrey D. Lebensburger, DO, University of Alabama at Birmingham

Study Description
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Brief Summary:
The investigators will attempt to develop a more accurate equation to estimate eGFR in pediatric and adult sickle cell patients

Condition or disease Intervention/treatment
Sickle Cell Disease Renal Disease Glomerular Disease Diagnostic Test: iohexol GFR

Detailed Description:

200 pediatric and 200 adult SCA participants will undergo mGFR using iohexol at baseline and at one year. On the same day, participants will undergo clinical and laboratory variables important for developing an eGFR equation. From baseline data, the investigators will perform a training and validation cohort of biologically relevant predictor variables to develop a novel equation. Then the investigators will compare the novel SCA eGFR equation to the established eGFR equation. From one year data, the investigators will determine the longitudinal concordance between pediatric and adult novel and standard eGFR equations with mGFR and variables that may alter longitudinal inferences.

In a subset of 30 adult participants, the investigators will also evaluate the correlation between mGFR using iohexol and a novel measure of mGFR that is more time efficient

Study Design
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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Improving Scientific Rigor of Renal Clinical Endpoints for Sickle Cell Anemia
Actual Study Start Date : May 12, 2021
Estimated Primary Completion Date : May 15, 2024
Estimated Study Completion Date : May 15, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia
Drug Information available for: Iohexol

Groups and Cohorts
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Group/Cohort Intervention/treatment
Pediatric SCA
We will develop a novel eGFR equation in 200 pediatric participants
 Diagnostic Test: iohexol GFR
We will perform mGFR in 400 SCA patients
Adult SCA
We will develop a novel eGFR equation in 200 adult participants
 Diagnostic Test: iohexol GFR
We will perform mGFR in 400 SCA patients


Outcome Measures
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Primary Outcome Measures :
  1. To develop a novel SCA-specific eGFR equation and compare with existing eGFR equations validated for the general population [ Time Frame: 5 years ]
    The investigators will use biologically relevant variables to develop a new equation for eGFR in pediatric and adult sickle cell patients


Secondary Outcome Measures :
  1. To determine the longitudinal concordance between pediatric and adult novel and standard eGFR equations with mGFR and variables that may alter longitudinal inferences. [ Time Frame: 5 years ]
    To compare the concordance between eGFR and mGFR from baseline to one year

  2. To test the correlation of the novel mGFR method using VFI FAST and iohexol mGFR. [ Time Frame: 5 years ]
    To perform a 3 hour mGFR and compare this mGFR to the 6 hour mGFR (iohexol)


Eligibility Criteria
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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.


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Ages Eligible for Study:   5 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients with sickle cell anemia
Criteria

Inclusion Criteria:

  • SCA patients (HbSS and SB0 thalassemia)
  • Age: 5.0-50.0 at enrollment

Exclusion Criteria:

  • Recent SCA complication associated with hospitalization (within 30 days) or ED visit (within 14 days)
  • Current AKI defined as >0.3mg/g increase in SCr from prior visit
  • Known history of anaphylaxis with contrast agent or known pregnancy
Contacts and Locations
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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): NCT04380610


Contacts
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Contact: Jeffrey Lebensburger, DO, MSPH 205 638-9285 jlebensburger@peds.uab.edu

Locations
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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35223
Contact: Jeffrey D Lebensburger, DO    205-638-9285    jlebensburger@peds.uab.edu   
Principal Investigator: Julie Kanter Washko, MD         
Principal Investigator: Jeffrey Lebensburger, DO, MSPH         
United States, Illinois
University of Illinois Chicage Recruiting
Chicago, Illinois, United States, 60612
Contact: Santosh Saraf, MD, BS         
United States, Tennessee
St Jude Childrens Research Hospital Recruiting
Memphis, Tennessee, United States, 38106
Contact: Jane Hankins, MD, MS         
University of Tennessee Health Science Center Recruiting
Memphis, Tennessee, United States, 38163
Contact: Kenneth Ataga, MBBS         
Sponsors and Collaborators
University of Alabama at Birmingham
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Jeffrey Lebensburger, DO, MSPH University of Alabama at Birmingham
More Information
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Responsible Party: Jeffrey D. Lebensburger, DO, PI, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT04380610    
Other Study ID Numbers: 1R01HL153386 ( U.S. NIH Grant/Contract )
First Posted: May 8, 2020    Key Record Dates
Last Update Posted: April 26, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data collected in this study will be made available to other researchers, after the goals have been met and primary aims have been published. Disclosure of sensitive health and behavior data present a potential risk to human subjects, and we will take all steps to ensure that this does not happen when data are shared. In addition, we will strongly recommend that all recipient groups ensure that every member of the staff sign a Confidentiality Agreement. We will develop a data and resource sharing agreement with the legal advice from the Compliance Office of the UAB. Before data is shared with researchers, we will require that researchers enter into a data- and resource-sharing agreement. This agreement will ensure that: 1) data are used only for research purposes; 2) data do not identify any individual participant; 3) data are secure, using appropriate computer technology; and 4) there is a commitment to destroy or return data after analyses are completed.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia
Hematologic Diseases
Anemia, Hemolytic, Congenital
 Anemia, Hemolytic
Hemoglobinopathies
Genetic Diseases, Inborn