RecruitingNCT06595420

Kidney Function in People With Cystic Fibrosis in the Era of HEMT

Sponsor

University of Virginia

Enrollment

260 participants

Start Date

Jan 9, 2025

Study Type

OBSERVATIONAL

Conditions

Acute Kidney Injury Chronic Kidney Disease(CKD)Cystic Fibrosis (CF)

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 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.

Eligibility

Min Age: 7 Years

Inclusion Criteria15

Outpatient CF Cohort
Diagnoses of Cystic Fibrosis
Age \&gt; 30 years old
Able to provide informed consent
Inpatient CF Cohort
Diagnoses of Cystic Fibrosis
Age \&gt; 7 years old
Able to provide informed consent and assent (where applicable)
PwCF frequently hospitalized for a pulmonary exacerbation (\&gt;1 hospital admission in the prior 12 months)
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 Criteria21

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 \&lt;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

Locations(3)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Dartmouth-Hitchcock Geisel School of Medicine at Dartmouth

Lebanon, New Hampshire, United States

University of Virginia Children's Hospital

Charlottesville, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT06595420

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