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

Status: Recruiting
Location: See all (3) locations...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 7
Healthy Volunteers: t
View:

• 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

Locations
United States
Alabama
University of Alabama at Birmingham
RECRUITING
Birmingham
New Hampshire
Dartmouth-Hitchcock Geisel School of Medicine at Dartmouth
NOT_YET_RECRUITING
Lebanon
Virginia
University of Virginia Children's Hospital
RECRUITING
Charlottesville
Contact Information
Primary
Agnieszka Swiatecka-Urban, MD
AS6XX@uvahealth.org
434-924-0946
Time Frame
Start Date: 2025-01-09
Estimated Completion Date: 2027-12
Participants
Target number of participants: 260
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: University of Virginia

This content was sourced from clinicaltrials.gov