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Cystic Fibrosis in the Kidney: Monitoring the Effectiveness of Elexacaftor/tezacaftor/ivacaftor in Urine After a Short Pause of Therapy
Sponsor: University of Aarhus
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2023-06-01
Completion Date
2025-12
Last Updated
2025-02-19
Healthy Volunteers
No
Conditions
Interventions
12 hours ETI pause
Patients with CF are randomly allocated to ETI pause lasting 12 hours.
36 hours ETI pause
Patients with CF are randomly allocated to ETI pause lasting either 36 hours.
60 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