Understanding kidney disease in people with cystic fibrosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to identify the causes of kidney disease in individuals with cystic fibrosis (CF) by analyzing biomarkers in blood and urine. It will compare these biomarkers over time in CF patients, particularly during lung flare-ups, and against samples from healthy individuals. The study seeks to uncover the impact of CF and its treatments on kidney function, with the goal of improving early detection and prevention strategies for kidney issues associated with CF.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Outpatient CF Cohort

   * 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 Criteria:

1. 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)
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

Where it's running

• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• Dartmouth-Hitchcock Geisel School of Medicine at Dartmouth
  Lebanon, New Hampshire, United States Recruiting
• University of Virginia Children's Hospital
  Charlottesville, Virginia, United States Recruiting

Study contacts

• Study coordinator: Agnieszka Swiatecka-Urban, MD
• Email: AS6XX@uvahealth.org
• Phone: 434-924-0946

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.