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

University of Virginia · NCT06595420

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 7+ · All sexes
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
260
US sites recruiting
3
Study start
January 9, 2025
Record last updated
May 4, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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: Cystic Fibrosis (CF); Chronic Kidney Disease(CKD); Acute Kidney Injury

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 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 Criteria

  • 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

Recruiting US locations

  • University of Alabama at Birmingham

    Birmingham, AL 35233

    Site contact: William T Harris, MD · 205-638-9583 · wtharris@uabmc.edu

  • Dartmouth-Hitchcock Geisel School of Medicine at Dartmouth

    Lebanon, NH 03756

    Site contact: Sladjana Skopelja-Gardner, PhD · 603-667-8259 · Sladjana.Skopelja-Gardner@dartmouth.edu

  • University of Virginia Children's Hospital

    Charlottesville, VA 22908

    Site contact: Agnieszka Swiatecka-Urban, MD · 434-924-0946 · AS6XX@uvahealth.org

Study contacts (from the official record)

  • Agnieszka Swiatecka-Urban, MD · 434-924-0946 · AS6XX@uvahealth.org
All healthy volunteers studies in Alabama →
Kidney Function in People With Cystic Fibrosis in the Era of HEMT (NCT06595420) | Bored Studies