No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
7 and older
Sex
Any
Study type
Observational
Participants needed
260 (estimated)
Sponsor
University of Virginia · Other
Who this trial is looking for
This trial is looking for people with cystic fibrosis to help understand kidney health. Participants will provide urine and blood samples to compare kidney markers over time.
Are You a Good Fit for This Trial?
Must not be takingAntibiotics
Rules you outKidney diseaseCancerOrgan transplant
You may be able to join if
I have been diagnosed with cystic fibrosis
I am older than 7 years old
I can provide consent
I am older than 30 years old
I can provide urine samples on my own
I have had more than one hospital visit for lung issues in the last year
I am healthy and can report it myself
I am between 30 and 50 years old
You may not be able to join if
I have had any organ transplant
I have a history of immunodeficiency
I have had cancer in the past or currently have it
I am pregnant or breastfeeding
I am on chronic dialysis
I started intravenous antibiotics after being admitted to the hospital
I have kidney disease or a chronic illness
I have urinary symptoms or a UTI right now
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 sa…
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.
Trial Locations
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City
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Status
Eligibility Criteria
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 appli…
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
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