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RECRUITINGOBSERVATIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Outpatient CF Cohort - Diagnoses of Cystic Fibrosis - Age \> 30 years old - Able to provide willing to sign a consent form 2. Inpatient CF Cohort - Diagnoses of Cystic Fibrosis - Age \> 7 years old - Able to provide willing to sign a consent form 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 willing to sign a consent form Who Should NOT Join This Trial: 1. Outpatient CF Cohort - History of any organ transplant - History of weakened immune system - 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 weakened immune system - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Locations (3)

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