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Cystic Fibrosis in the Kidney: Monitoring the Effectiveness of Elexacaftor/tezacaftor/ivacaftor in Urine After a Short Pause of Therapy | Clinical Trials | Clareo Health

RECRUITINGNA

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

NCT05818319•University of Aarhus

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Adult (age \>17 years) CF patients.
•Normal kidney function estimated by eGFR\>90.
•Adults capable of understanding and voluntarily consenting.

Exclusion Criteria

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

Locations (1)

Department of Infectious Diseases, Aarhus University Hospital

Aarhus C, Central Jutland, Denmark

Key Dates

Start Date

June 1, 2023

Primary Completion Date

December 1, 2025

Completion Date

December 1, 2025

Last Updated

February 19, 2025

Enrollment

ESTIMATED participants

Conditions

Cystic Fibrosis (CF)CFTR Gene Mutation

Interventions

12 hours ETI pause

OTHER

36 hours ETI pause

OTHER

60 hours ETI pause

OTHER

Contacts

Amalie Q. Rousing, BM

CONTACT

arousing@biomed.au.dk

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Proof-of-concept Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of SION-719 When Added to Trikafta

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Population Pharmacokinetics of Elexacaftor-tezacaftor-ivacaftor in a Paediatric Population

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 19, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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

Inclusion Criteria

Exclusion Criteria

Personalized Mobile Health Platform to Promote Physical Activity in Adolescents and Young Adults With Cystic Fibrosis

Proof-of-concept Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of SION-719 When Added to Trikafta

Population Pharmacokinetics of Elexacaftor-tezacaftor-ivacaftor in a Paediatric Population

The School-Age Children With Cystic Fibrosis and Their Parents on Health Literacy

Safety, Tolerability and Efficacy Study of ARCT-032 in People With Cystic Fibrosis

Safety, Tolerability, and Pharmacokinetics of Multiple Dose Combinations of SION-451 and Complementary Modulators SION-2222 and SION-109 in Healthy Participants.