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New study aims to uncover hidden kidney risks in cystic fibrosis patients

NCT ID NCT06595420

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at why people with cystic fibrosis often develop kidney disease. Researchers will test blood and urine samples for early signs of kidney damage, comparing CF patients with and without frequent hospital stays, as well as people without CF. The goal is to find better ways to predict, detect, and prevent kidney problems in this population.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to better ways to detect and prevent kidney damage in people with cystic fibrosis.
What could go wrong
This is an observational study, not a treatment trial. It may not directly change care, and results may not apply to all CF patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 260 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Participants will be derived from patients with CF with ongoing care at one of the 3 CF Centers (Dartmouth, UAB, UVA).

Ages

7 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Dartmouth-Hitchcock Geisel School of Medicine at Dartmouth

    RECRUITING

    Lebanon, New Hampshire, 03756, United States

  • University of Alabama at Birmingham

    RECRUITING

    Birmingham, Alabama, 35233, United States

  • University of Virginia Children's Hospital

    RECRUITING

    Charlottesville, Virginia, 22908, United States

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