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OpenTrials
Completed

NCT Number: NCT04380610

Improving Scientific Rigor of Renal Clinical Endpoints for Sickle Cell Anemia

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

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Key information

Conditions

Sickle Cell Disease Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Glomerular Disease Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies Kidney Diseases Male Urogenital Diseases Renal Disease Urogenital Diseases Urologic Diseases

Age range

5 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

iohexol GFR

Diagnostic Test

We will perform mGFR in 400 SCA patients

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
May 8, 2020
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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