RecruitingNot ApplicableNCT05818319

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


Sponsor

University of Aarhus

Enrollment

30 participants

Start Date

Jun 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying 12 hours ETI pause, 36 hours ETI pause, and others for people with cftr gene mutation and cystic fibrosis (cf). The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHER12 hours ETI pause

Patients with CF are randomly allocated to ETI pause lasting 12 hours.

OTHER36 hours ETI pause

Patients with CF are randomly allocated to ETI pause lasting either 36 hours.

OTHER60 hours ETI pause

Patients with CF are randomly allocated to ETI pause lasting either 60 hours.


Locations(1)

Department of Infectious Diseases, Aarhus University Hospital

Aarhus C, Central Jutland, Denmark

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NCT05818319


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