Back to search results

Kidney Function in People With Cystic Fibrosis

This study aims to understand why people with cystic fibrosis (CF) develop kidney disease. Researchers will look at markers in your blood and urine that could help predict who is at risk or find kidney damage early. They will compare these markers over time in people with CF, especially during lung flare-ups, and with people who don't have CF. The goal is to better understand how CF and its treatments affect kidneys, and to find new ways to prevent, diagnose, and treat kidney problems related to CF. You can join if you have CF and are over 7 years old (for inpatients) or over 30 years old (for outpatients). The study will be successful if it finds links between kidney function changes and these markers, and if it helps understand why some people with CF are hospitalized more often.

Study design
This is an observational study involving 260 participants, including outpatients with CF, inpatients with CF, and healthy individuals.
What's involved
You would provide blood and urine samples at enrollment and every 3 months for 24 months. If hospitalized, samples would be taken on admission, every 48 hours, and after discharge at routine CF care visits.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 24 months after enrollment or discharge.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06595420

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

Recruiting
Not specifiedAges 7+Observational
University of Virginia
~260 participants
Updated 2026-05-04 on ClinicalTrials.gov

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Examine whether trajectories of eGFR (calculated from serum creatinine and cystatin C) correlate with urinary kidney injury signatures detected in different urine fractions, or urinary neutrophil levels/activation.
Measured over Enrollment and every 3 months for 24 months
+2 more outcomes measured

Conditions

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

Explore related trials

Acute Renal FailureChronic Kidney DiseaseCystic Fibrosis

Where it's being run

3 sites across 3 states
Alabama1
New Hampshire1
Virginia1

Who to contact

Agnieszka Swiatecka-Urban, MD
[email protected]
434-924-0946
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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

What this trial measures

  • Examine whether trajectories of eGFR (calculated from serum creatinine and cystatin C) correlate with urinary kidney injury signatures detected in different urine fractions, or urinary neutrophil levels/activation.Enrollment and every 3 months for 24 months

    Outpatient CF Cohort

  • Correlation between recurrent hospitalizations and urinary kidney injury signature.On admission before the initiation of intravenous antibiotic therapy, every 48 hrs during the hospitalization, after discharge at each subsequent routine CF care visit for 24 months.

    Inpatient CF Cohort

  • Relationship between recurrent hospitalization and change in slope of eGFROn admission before the initiation of intravenous antibiotic therapy, every 48 hrs during the hospitalization, after discharge at each subsequent routine CF care visit for 24 months.

    Inpatient CF Cohort