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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Virginia
Study ID
NCT06595420
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
7 Years - N/A
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

Start date
Jan 9, 2025
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
260 participants (estimated)

Arms

  • Arm: 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).
  • Arm: Inpatient CF Cohort
    Hospitalized CF cohort: Diagnosis of CF, age \>7 y, being admitted for intravenous antibiotic treatment of pulmonary exacerbation.
  • Arm: 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 ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35233
William T Harris, MD
[email protected]
205-638-9583
Dartmouth-Hitchcock Geisel School of Medicine at DartmouthLebanonNew Hampshire03756
Sladjana Skopelja-Gardner, PhD
[email protected]
603-667-8259
Alix Ashare, MD (PRINCIPAL_INVESTIGATOR)
University of Virginia Children's HospitalCharlottesvilleVirginia22908
Agnieszka Swiatecka-Urban, MD
[email protected]
434-924-0946

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, ALDartmouth-Hitchcock Geisel School of Medicine at Dartmouth· Lebanon, NHUniversity of Virginia Children's Hospital· Charlottesville, VA

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