Kidney Function in People With Cystic Fibrosis in the Era of HEMT
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age7+
SponsorUniversity of Virginia
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Outpatient CF Cohort
Diagnoses of Cystic Fibrosis
Age > 30 years old
Able to provide informed consent
Disqualifiers
Outpatient CF Cohort
History of any organ transplant
History of immunodeficiency
Previous or current cancer diagnoses
Trial population
Participants will be derived from patients with CF with ongoing care at one of the 3 CF Centers (Dartmouth, UAB, UVA).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
260 Participants
are grouped into 3 trial groupsGroup A: Outpatient CF Cohort
Group B: Inpatient CF Cohort
Group C: Healthy Controls
Trial outcomes
Primary outcomes
1
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.
Outpatient CF Cohort
Time frame
Enrollment and every 3 months for 24 months2
Correlation between recurrent hospitalizations and urinary kidney injury signature.
Inpatient CF Cohort
Time frame
On admission before the initiation of intravenous antibiotic therapy, every 48 hrs during the hospitalization, after discharge at each subsequent routine CF care visit for 24 months.3
Relationship between recurrent hospitalization and change in slope of eGFR
Inpatient CF Cohort
Time frame
On admission before the initiation of intravenous antibiotic therapy, every 48 hrs during the hospitalization, after discharge at each subsequent routine CF care visit for 24 months.Secondary outcomes
1
The correlation between changes in the urinary protein biomarker panel, neutrophil activation, and extracellular vesicles over time and eGFR.
Outpatient CF Cohort
Time frame
Enrollment and every 3 months for 24 months.2
Correlation between %FEV1 at admission or decline in %FEV1 and urinary kidney injury signature.
Inpatient CF Cohort
Time frame
On admission before the initiation of intravenous antibiotic therapy, every 48 hrs during the hospitalization, after discharge at each subsequent routine CF care visit for 24 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov