Developing a better method to estimate kidney function in sickle cell patients
Improving Scientific Rigor of Renal Clinical Endpoints for Sickle Cell Anemia
University of Alabama at Birmingham · NCT04380610
This study is testing a new way to measure kidney function in people with sickle cell anemia to see if it gives more accurate results than current methods.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 5 Years to 50 Years |
| Sex | All |
| Sponsor | University of Alabama at Birmingham (other) |
| Locations | 4 sites (Birmingham, Alabama and 3 other locations) |
| Trial ID | NCT04380610 on ClinicalTrials.gov |
What this trial studies
This observational study aims to create a more accurate equation for estimating the estimated Glomerular Filtration Rate (eGFR) in both pediatric and adult patients with sickle cell anemia (SCA). A total of 400 participants will undergo a measurement of their mGFR using iohexol at the beginning and after one year, alongside clinical and laboratory assessments. The data collected will be used to develop and validate a novel eGFR equation specifically for SCA patients, which will then be compared to existing eGFR equations. Additionally, a subset of adult participants will explore a new, more efficient method for measuring mGFR.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 5 to 50 with sickle cell anemia, specifically those with HbSS or SB0 thalassemia.
Not a fit: Patients who have had recent complications requiring hospitalization or emergency department visits, or those with acute kidney injury, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved kidney function assessments for sickle cell patients, enhancing their overall care and management.
How similar studies have performed: While this approach is focused on a specific patient population, similar studies have shown promise in improving kidney function assessments, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Birmingham, Alabama and 3 other locations
- University of Alabama at Birmingham — Birmingham, Alabama, United States (RECRUITING)
- University of Illinois Chicage — Chicago, Illinois, United States (RECRUITING)
- St Jude Childrens Research Hospital — Memphis, Tennessee, United States (RECRUITING)
- University of Tennessee Health Science Center — Memphis, Tennessee, United States (RECRUITING)
Study contacts
- Principal investigator: Jeffrey Lebensburger, DO, MSPH — University of Alabama at Birmingham
- Study coordinator: Jeffrey Lebensburger, DO, MSPH
- Email: jlebensburger@peds.uab.edu
- Phone: 205 638-9285
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Sickle Cell Disease, Renal Disease, Glomerular Disease