Improving Scientific Rigor of Renal Clinical Endpoints for Sickle Cell Anemia

Last updated: May 28, 2024
Sponsor: University of Alabama at Birmingham
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sickle Cell Disease

Focal Segmental Glomerulosclerosis

Nephropathy

Treatment

iohexol GFR

Clinical Study ID

NCT04380610
IRB-300005433
1R01HL153386
  • Ages 5-50
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The investigators will attempt to develop a more accurate equation to estimate eGFR in pediatric and adult sickle cell patients

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • SCA patients (HbSS and SB0 thalassemia)

  • Age: 5.0-50.0 at enrollment

Exclusion

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

Study Design

Total Participants: 400
Treatment Group(s): 1
Primary Treatment: iohexol GFR
Phase:
Study Start date:
May 12, 2021
Estimated Completion Date:
May 15, 2025

Study 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

Connect with a study center

  • University of Alabama at Birmingham

    Birmingham, Alabama 35223
    United States

    Active - Recruiting

  • University of Illinois Chicage

    Chicago, Illinois 60612
    United States

    Active - Recruiting

  • St Jude Childrens Research Hospital

    Memphis, Tennessee 38106
    United States

    Active - Recruiting

  • University of Tennessee Health Science Center

    Memphis, Tennessee 38163
    United States

    Active - Recruiting

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