Improving Scientific Rigor of Renal Clinical Endpoints for Sickle Cell Anemia
2 other identifiers
observational
120
1 country
4
Brief Summary
The investigators will attempt to develop a more accurate equation to estimate eGFR in pediatric and adult sickle cell patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2021
Longer than P75 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 5, 2020
CompletedFirst Posted
Study publicly available on registry
May 8, 2020
CompletedStudy Start
First participant enrolled
May 12, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2025
CompletedSeptember 18, 2025
September 1, 2025
4.1 years
May 5, 2020
September 12, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
To develop a novel SCA-specific eGFR equation and compare with existing eGFR equations validated for the general population
The investigators will use biologically relevant variables to develop a new equation for eGFR in pediatric and adult sickle cell patients
5 years
Secondary Outcomes (2)
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 test the correlation of the novel mGFR method using VFI FAST and iohexol mGFR.
5 years
Study Arms (2)
Pediatric SCA
We will develop a novel eGFR equation in 200 pediatric participants
Adult SCA
We will develop a novel eGFR equation in 200 adult participants
Interventions
Eligibility Criteria
Patients with sickle cell anemia
You may qualify if:
- SCA patients (HbSS and SB0 thalassemia)
- Age: 5.0-50.0 at enrollment
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
University of Alabama at Birmingham
Birmingham, Alabama, 35223, United States
University of Illinois Chicage
Chicago, Illinois, 60612, United States
St Jude Childrens Research Hospital
Memphis, Tennessee, 38106, United States
University of Tennessee Health Science Center
Memphis, Tennessee, 38163, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeffrey Lebensburger, DO, MSPH
University of Alabama at Birmingham
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PI
Study Record Dates
First Submitted
May 5, 2020
First Posted
May 8, 2020
Study Start
May 12, 2021
Primary Completion
June 30, 2025
Study Completion
June 30, 2025
Last Updated
September 18, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
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.