NCT06595420 Kidney Function in People With Cystic Fibrosis in the Era of HEMT
| NCT ID | NCT06595420 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Virginia |
| Condition | Cystic Fibrosis (CF) |
| Study Type | OBSERVATIONAL |
| Enrollment | 260 participants |
| Start Date | 2025-01-09 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 260 participants in total. It began in 2025-01-09 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06595420 clinical trial?
This trial is open to participants of all sexes, aged 7 Years or older, studying Cystic Fibrosis (CF). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06595420 currently recruiting?
Yes, NCT06595420 is actively recruiting participants. Contact the research team at AS6XX@uvahealth.org for enrollment information.
Where is the NCT06595420 trial being conducted?
This trial is being conducted at Birmingham, United States, Lebanon, United States, Charlottesville, United States.
Who is sponsoring the NCT06595420 clinical trial?
NCT06595420 is sponsored by University of Virginia. The trial plans to enroll 260 participants.