NCT06595420 · University of Virginia
Kidney Function in People With Cystic Fibrosis in the Era of HEMT
What this 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.
View original scientific description
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 can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Birmingham, Alabama
- Lebanon, New Hampshire
- Charlottesville, Virginia
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 4, 2026 · Source of record for eligibility and locations