NCT06595420Recruiting
Kidney Function in People With Cystic Fibrosis in the Era of HEMT
Source: ClinicalTrials.gov · Last updated 4 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 260 (estimated)
- First submitted
- 10 Sept 2024
- Start date
- 9 Jan 2025
- Primary completion date
- Dec 2027
- Lead sponsor
- University of Virginia
- Diseases
- Chronic kidney disease, Cystic fibrosis
- NCT number
- NCT06595420
What you commit to
- Study type: Observational
- Planned participants: 260
- From 9 Jan 2025 to the primary completion date, Dec 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Who the study is looking for
- 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
Age in the registry: 7 years to - · Sex: All · Accepts healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Alabama at Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Recruiting |
| University of Virginia Children's Hospital Coordinator of this site? Confirm its status | Charlottesville | United States | Recruiting |
| Dartmouth-Hitchcock Geisel School of Medicine at Dartmouth Coordinator of this site? Confirm its status | Lebanon | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.