NCT05818319Recruiting
Cystic Fibrosis in the Kidney: Monitoring the Effectiveness of Elexacaftor/tezacaftor/ivacaftor in Urine After a Short Pause of Therapy
Source: ClinicalTrials.gov · Last updated 19 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 28 Mar 2023
- Start date
- 1 Jun 2023
- Primary completion date
- Dec 2025
- Lead sponsor
- University of Aarhus
- Diseases
- Cystic fibrosis
- NCT number
- NCT05818319
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 1 Jun 2023 to the primary completion date, Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Critical acute illness.
- Severe lung disease (ppFEV1\<40%).
Other
- Adults not capable of understanding and voluntarily consenting.
Who the study is looking for
- Adult (age \>17 years) CF patients.
- Normal kidney function estimated by eGFR\>90.
- Adults capable of understanding and voluntarily consenting.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Infectious Diseases, Aarhus University Hospital Coordinator of this site? Confirm its status | Aarhus C | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.