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

NCT05818319 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-02-19

No results posted yet for this study

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.

Conditions

  • Cystic Fibrosis (CF)
  • CFTR Gene Mutation

Interventions

OTHER

12 hours ETI pause

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

OTHER

36 hours ETI pause

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

OTHER

60 hours ETI pause

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

Sponsors & Collaborators

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Jens G. Leipziger · Department of Biomedicine, Aarhus University, Denmark

  • Majbritt Jeppesen · Department of Infectious Diseases, Aarhus University Hospital, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05818319 on ClinicalTrials.gov