Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05818319

Cystic Fibrosis in the Kidney: Monitoring the Effectiveness of Elexacaftor/tezacaftor/ivacaftor in Urine After a Short Pause of Therapy

Led by University of Aarhus · Updated on 2025-02-19

30

Participants Needed

1

Research Sites

130 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

In cystic fibrosis (CF) renal base excretion is impaired, due to mutations in the Cystic Fibrosis Transmembrane Regulator (CFTR) gene, since CFTR function is crucial in regulation of the kidney's HCO3- excretion. The investigators suggest that challenged urine HCO3- excretion is a biomarker of CFTR function, which can be used to evaluate the extent of CFTR dysfunction and the possible correcting effects of CFTR modulating therapy. This study aims to evaluate changes in challenged urine HCO3- excretion in CF patients, who are currently in treatment with the triple CFTR modulator combination therapy, Elexacaftor/tezacaftor/ivacaftor (ETI), before, during, and after a short treatment pause.

CONDITIONS

Official Title

Cystic Fibrosis in the Kidney: Monitoring the Effectiveness of Elexacaftor/tezacaftor/ivacaftor in Urine After a Short Pause of Therapy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult (age >17 years) CF patients
  • Normal kidney function estimated by eGFR >90
  • Adults capable of understanding and voluntarily consenting
Not Eligible

You will not qualify if you...

  • Critical acute illness
  • Severe lung disease (ppFEV1 <40%)
  • Adults not capable of understanding and voluntarily consenting

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Department of Infectious Diseases, Aarhus University Hospital

Aarhus C, Central Jutland, Denmark, 8000

Actively Recruiting

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Research Team

A

Amalie Q. Rousing, BM

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

3

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