Kidney Function in People With Cystic Fibrosis in the Era of HEMT
Recruiting now
Conditions studied: Cystic Fibrosis (CF), Chronic Kidney Disease(CKD), Acute Kidney Injury
In brief
The purpose of this study is to find out what causes kidney disease in people with CF. The investigators will study biomarkers in the blood and urine that can either predict who is at risk or detect kidney damage early before it becomes permanent. The study will compare these markers in people with CF over time and during the treatment of lung flare-ups. It will also compare the blood and urine samples obtained from people without CF. The comparison aims to better understand the impact of cystic fibrosis and its treatment on the kidneys, as well as to develop improved methods for preventing, diagnosing, and treating kidney issues associated with CF.
Key facts
- Study ID
- NCT06595420
- Run by
- University of Virginia
- People needed
- 260
- Starts
- 2025-01-09
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2026-05-04
Who can join
Age: 7 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Outpatient CF Cohort
- Diagnoses of Cystic Fibrosis
- Age \> 30 years old
- Able to provide informed consent
- 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
- Healthy Controls
- Healthy, as per participant self-report
- Age between 30-50 years
- Able to provide informed consent
You may not qualify if…
- 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)
- 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
- 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 it is running
- University of Alabama at Birmingham — Birmingham, Alabama, United States (enrolling)
- Dartmouth-Hitchcock Geisel School of Medicine at Dartmouth — Lebanon, New Hampshire, United States (enrolling)
- University of Virginia Children's Hospital — Charlottesville, Virginia, United States (enrolling)
Full record on ClinicalTrials.gov
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