Understanding kidney disease in people with cystic fibrosis
Kidney Function in People With Cystic Fibrosis in the Era of HEMT
This study looks at how cystic fibrosis affects kidney health by checking blood and urine samples to help find ways to spot and prevent kidney problems early.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 260 (estimated) |
| Ages | 7 Years and up |
| Sex | All |
| Sponsor | University of Virginia Academic / other |
| Locations | 3 sites (Birmingham, Alabama and 2 other locations) |
| Trial ID | NCT06595420 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify the causes of kidney disease in individuals with cystic fibrosis (CF) by analyzing biomarkers in blood and urine. It will compare these biomarkers over time in CF patients, particularly during lung flare-ups, and against samples from healthy individuals. The study seeks to uncover the impact of CF and its treatments on kidney function, with the goal of improving early detection and prevention strategies for kidney issues associated with CF.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with cystic fibrosis aged 7 years and older, as well as healthy controls aged 30-50 years.
Not a fit: Patients with a history of organ transplant, immunodeficiency, or current cancer diagnoses may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better methods for preventing and treating kidney disease in patients with cystic fibrosis.
How similar studies have performed: While the study addresses a significant gap in understanding kidney function in CF, similar approaches have shown promise in other contexts, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Outpatient CF Cohort * Diagnoses of Cystic Fibrosis * Age \> 30 years old * Able to provide informed consent 2. Inpatient CF Cohort * Diagnoses of Cystic Fibrosis * Age \> 7 years old * Able to provide informed consent and assent (where applicable) * 55 PwCF frequently hospitalized for a pulmonary exacerbation (\>1 hospital admission in the prior 12 months) * 55 PwCF sporadically hospitalized for a pulmonary exacerbation (no hospital admissions in the prior 12 months) * Able to provide urine sample independently 3. Healthy Controls * Healthy, as per participant self-report * Age between 30-50 years * Able to provide informed consent Exclusion Criteria: 1. Outpatient CF Cohort * History of any organ transplant * History of immunodeficiency * Previous or current cancer diagnoses * Pregnant or breastfeeding * On chronic dialysis * Non-compliance (demonstrated by \<2 visits during the 12 months before enrollment) 2. Inpatient CF Cohort * The initiation of intravenous antibiotic therapy after hospital admission before obtaining the first blood and urine sample * History of any organ transplant * History of immunodeficiency * Previous or current cancer diagnoses * Pregnant or breastfeeding * On chronic dialysis 3. Healthy Controls * History or current kidney disease, organ transplantation, cancer, or any other chronic illness * Current use of antibiotics * Urinary symptoms or UTI (dysuria, frequency, urgency) * Pregnant women * Menstruating on the study visit day * Blood relatives of PwCF
Where this trial is running
Birmingham, Alabama and 2 other locations
- University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
- Dartmouth-Hitchcock Geisel School of Medicine at Dartmouth — Lebanon, New Hampshire, United States (Recruiting)
- University of Virginia Children's Hospital — Charlottesville, Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Agnieszka Swiatecka-Urban, MD
- Email: AS6XX@uvahealth.org
- Phone: 434-924-0946
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.