RECRUITING

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

Conditions

Cystic Fibrosis (CF)Chronic Kidney Disease(CKD)Acute Kidney Injury

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-10

Study Completion:2027-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06595420

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:7 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Outpatient CF Cohort * Diagnoses of Cystic Fibrosis * Age \&gt; 30 years old * Able to provide informed consent 2. Inpatient CF Cohort * Diagnoses of Cystic Fibrosis * Age \&gt; 7 years old * Able to provide informed consent and assent (where applicable) * 55 PwCF frequently hospitalized for a pulmonary exacerbation (\&gt;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	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 \&lt;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

Inclusion Criteria

Exclusion Criteria

1. Outpatient CF Cohort
* Diagnoses of Cystic Fibrosis
* Age \&gt; 30 years old
* Able to provide informed consent
2. Inpatient CF Cohort
* Diagnoses of Cystic Fibrosis
* Age \&gt; 7 years old
* Able to provide informed consent and assent (where applicable)
* 55 PwCF frequently hospitalized for a pulmonary exacerbation (\&gt;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

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 \&lt;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

Contacts and Locations

Study Contact

Agnieszka Swiatecka-Urban, MD

CONTACT

434-924-0946

AS6XX@uvahealth.org

Study Locations (Sites)

University of Alabama at Birmingham

Birmingham, Alabama, 35233

United States

Dartmouth-Hitchcock Geisel School of Medicine at Dartmouth

Lebanon, New Hampshire, 03756

United States

University of Virginia Children's Hospital

Charlottesville, Virginia, 22908

United States

Collaborators and Investigators

Sponsor: University of Virginia

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10

Study Completion Date2027-10

Study Record Updates

Study Start Date2024-10

Study Completion Date2027-10

Terms related to this study

Additional Relevant MeSH Terms

Cystic Fibrosis (CF)
Chronic Kidney Disease(CKD)
Acute Kidney Injury