Kidney Urine Testing in Cystic Fibrosis Patients Pausing Elexacaftor/tezacaftor/ivacaftor Treatment
Studies urine bicarbonate in adults with cystic fibrosis during short pauses of elexacaftor/tezacaftor/ivacaftor.
Plain-language title generated from the registry record
Registry title: Cystic Fibrosis in the Kidney: Monitoring the Effectiveness of Elexacaftor/tezacaftor/ivacaftor in Urine After a Short Pause of Therapy
Key facts
- Where
- Aarhus C, DenmarkSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with cystic fibrosis who already take Elexacaftor/tezacaftor/ivacaftor (ETI) and have normal kidney function. It tests urine changes during a short pause of ETI.
- Age
- Adults, over 17 years (minimum age 18 years).
- Sex
- All sexes can join.
- Disease stage
- Cystic fibrosis with normal kidney function (eGFR>90). Severe lung disease (ppFEV1<40%) is not allowed.
- Earlier treatment
- The summary says people are currently treated with Elexacaftor/tezacaftor/ivacaftor (ETI).
Main reasons for not taking part
- Critical acute illness
- Severe lung disease (ppFEV1<40%)
- Not able to understand and freely agree to take part
Read by machine on 9 November 2026.
Where in Denmark
- Department of Infectious Diseases, Aarhus University HospitalAarhus C, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Aarhus
- Trial code
- NCT05818319
- Record updated
- 19 February 2025
- Original description
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.Read full original descriptionShow less
Cystic Fibrosis in the Kidney: Monitoring the Effectiveness of Elexacaftor/tezacaftor/ivacaftor in Urine After a Short Pause of Therapy
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.
Inclusion: Adult (age >17 years) CF patients; Normal kidney function estimated by eGFR>90; Adults capable of understanding and voluntarily consenting.
Exclusion: Critical acute illness; Severe lung disease (ppFEV1<40%); Adults not capable of understanding and voluntarily consenting.