Recruiting

HEMT

Sponsor:

University of Virginia

Code:

NCT06595420

Conditions

Cystic Fibrosis (CF)

Chronic Kidney Disease(CKD)

Acute Kidney Injury

Eligibility Criteria

Sex: All

Age: 7+

Healthy Volunteers: Accepted

Study Details

Brief 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.

Conditions

Cystic Fibrosis (CF)

Chronic Kidney Disease(CKD)

Acute Kidney Injury

Study ID

NCT06595420

Start date

Jan 9, 2025

Status verified date

Apr, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

260 participants

Anticipated

Interventions and Outcome Measures

Arms

Outpatient CF Cohort

Not hospitalized CF group: Diagnosis of CF, age >30 y, with ongoing care at one of the 3 CF Centers (Dartmouth, UAB, UVA).

Inpatient CF Cohort

Hospitalized CF cohort: Diagnosis of CF, age >7 y, being admitted for intravenous antibiotic treatment of pulmonary exacerbation.

Healthy Controls

Healthy Volunteers without CF

Primary outcome measure

  • 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. [ Time Frame: Enrollment and every 3 months for 24 months ]
  • Correlation between recurrent hospitalizations and urinary kidney injury signature. [ Time Frame: 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. ]
  • Relationship between recurrent hospitalization and change in slope of eGFR [ Time Frame: 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. ]

Central Contacts and Locations

Central contacts

Agnieszka Swiatecka-Urban, MD

434-924-0946AS6XX@uvahealth.org

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

William T Harris, MD

205-638-9583wtharris@uabmc.edu

Dartmouth-Hitchcock Geisel School of Medicine at Dartmouth

Recruiting

Lebanon, New Hampshire, United States, 03756

Contacts

Sladjana Skopelja-Gardner, PhD

603-667-8259Sladjana.Skopelja-Gardner@dartmouth.edu

Principal Investigator:

Alix Ashare, MD

University of Virginia Children's Hospital

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Agnieszka Swiatecka-Urban, MD

434-924-0946AS6XX@uvahealth.org

More Information

Sponsor

University of Virginia

Last update posted

May 4, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Virginia on 2026-05-04.