Improving Scientific Rigor of Renal Clinical Endpoints for Sickle Cell Anemia

Recruiting

• Conditions: Glomerular Disease; Sickle Cell Disease; Renal Disease
• Interventions: Diagnostic Test: iohexol GFR

• Registration Number: NCT04380610
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

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

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-05-05
• Study First Submitted QC: 2020-05-05
• Study First Posted: 2020-05-08
• Study Start: 2021-05-12
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-28
• Last Update Posted: 2024-05-29
• Primary Completion: 2025-05-15
• Study Completion: 2025-05-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adult SCA	iohexol GFR	We will develop a novel eGFR equation in 200 adult participants
Pediatric SCA	iohexol GFR	We will develop a novel eGFR equation in 200 pediatric participants

Primary Outcome Measures

Name	Time	Method
To develop a novel SCA-specific eGFR equation and compare with existing eGFR equations validated for the general population	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

Name	Time	Method
To determine the longitudinal concordance between pediatric and adult novel and standard eGFR equations with mGFR and variables that may alter longitudinal inferences.	5 years	To compare the concordance between eGFR and mGFR from baseline to one year
To test the correlation of the novel mGFR method using VFI FAST and iohexol mGFR.	5 years	To perform a 3 hour mGFR and compare this mGFR to the 6 hour mGFR (iohexol)

Trial Locations

Locations (4)

University of Illinois Chicage; 🇺🇸 Chicago, Illinois, United States

University of Tennessee Health Science Center; 🇺🇸 Memphis, Tennessee, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

St Jude Childrens Research Hospital; 🇺🇸 Memphis, Tennessee, United States