Home › Cystic Fibrosis › NCT06595420
Kidney Function in People With Cystic Fibrosis in the Era of HEMT
Who can join
Ages 7 and older · All sexes · Healthy volunteers welcome
Full eligibility 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
About the study
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.
Sponsor: University of Virginia · Participants: 260 · Started: Jan 9, 2025
Contact the study team
- Agnieszka Swiatecka-Urban, MD · Phone: 434-924-0946
Official record on ClinicalTrials.gov — NCT06595420
Locations in the U.S.
| Alabama | University of Alabama at Birmingham, Birmingham |
| New Hampshire | Dartmouth-Hitchcock Geisel School of Medicine at Dartmouth, Lebanon |
| Virginia | University of Virginia Children's Hospital, Charlottesville |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.