Actively Recruiting

Age: 7Years +
All Genders
Healthy Volunteers
NCT06595420

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

Led by University of Virginia · Updated on 2026-05-04

260

Participants Needed

3

Research Sites

150 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 7Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with cystic fibrosis
  • Age over 30 years for outpatient CF group
  • Able to provide informed consent
  • Age over 7 years for inpatient CF group
  • Able to provide informed consent and assent if applicable
  • For inpatient group: 55 frequently hospitalized CF patients (>1 hospital admission in prior 12 months)
  • For inpatient group: 55 sporadically hospitalized CF patients (no hospital admissions in prior 12 months)
  • Able to provide urine sample independently
  • Healthy controls must be healthy by self-report
  • Healthy controls aged between 30 and 50 years
  • Healthy controls able to provide informed consent
Not Eligible

You will not qualify if you...

  • History of any organ transplant
  • History of immunodeficiency
  • Previous or current cancer diagnosis
  • Pregnant or breastfeeding
  • On chronic dialysis
  • Non-compliance (less than 2 visits during 12 months before enrollment) for outpatient CF group
  • Initiation of intravenous antibiotic therapy after hospital admission before first blood and urine sample for inpatient CF group
  • Healthy controls with history or current kidney disease, organ transplant, cancer, or other chronic illness
  • Healthy controls currently using antibiotics
  • Healthy controls with urinary symptoms or urinary tract infection
  • Pregnant women and menstruating women on study visit day in healthy controls
  • Blood relatives of people with CF in healthy controls

AI-Screening

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Trial Site Locations

Total: 3 locations

1

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35233

Actively Recruiting

2

Dartmouth-Hitchcock Geisel School of Medicine at Dartmouth

Lebanon, New Hampshire, United States, 03756

Actively Recruiting

3

University of Virginia Children's Hospital

Charlottesville, Virginia, United States, 22908

Actively Recruiting

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Research Team

A

Agnieszka Swiatecka-Urban, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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