Actively Recruiting
Cystic Fibrosis in the Kidney: Monitoring the Effectiveness of Elexacaftor/tezacaftor/ivacaftor in Urine After a Short Pause of Therapy
Led by University of Aarhus · Updated on 2025-02-19
30
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Cystic Fibrosis in the Kidney: Monitoring the Effectiveness of Elexacaftor/tezacaftor/ivacaftor in Urine After a Short Pause of Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult (age >17 years) CF patients
- Normal kidney function estimated by eGFR >90
- Adults capable of understanding and voluntarily consenting
You will not qualify if you...
- Critical acute illness
- Severe lung disease (ppFEV1 <40%)
- Adults not capable of understanding and voluntarily consenting
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Infectious Diseases, Aarhus University Hospital
Aarhus C, Central Jutland, Denmark, 8000
Actively Recruiting
Research Team
A
Amalie Q. Rousing, BM
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
3
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