Status:
RECRUITING
Kidney Function in People With Cystic Fibrosis in the Era of HEMT
Lead Sponsor:
University of Virginia
Conditions:
Cystic Fibrosis (CF)
Chronic Kidney Disease(CKD)
Eligibility:
All Genders
7+ years
Brief Summary
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 k...
Detailed Description
The prevalence of chronic kidney disease is significantly increased in patients with cystic fibrosis (PwCF) with a major impact on morbidity and medication tolerance as people age. Although expressed ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 9 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT06595420
Start Date
January 9 2025
End Date
December 1 2027
Last Update
April 15 2025
Active Locations (3)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
Dartmouth-Hitchcock Geisel School of Medicine at Dartmouth
Lebanon, New Hampshire, United States, 03756
3
University of Virginia Children's Hospital
Charlottesville, Virginia, United States, 22908