Impaired Renal HCO3- Excretion in Cystic Fibrosis.
Peder Berg, Samuel L Svendsen, Mads V Sorensen...
https://pubmed.ncbi.nlm.nih.gov/32703846Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID05818319
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
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are studying cystic fibrosis (CF), a condition caused by mutations in the CFTR gene which affects kidney function, specifically the kidney's ability to regulate bicarbonate (HCO3-) excretion. The study focuses on measuring changes in urine bicarbonate excretion as a biomarker of CFTR function. It aims to evaluate how the triple CFTR modulator therapy Elexacaftor/tezacaftor/ivacaftor (ETI) affects this kidney function before, during, and after a short pause in treatment. Participants with CF who are currently treated with ETI will be randomly assigned to pause their therapy for 12, 36, or 60 hours. Researchers will monitor changes in urine bicarbonate excretion and ETI plasma concentrations at baseline, during the pause, and after therapy is resumed. This randomized trial does not include blinding and compares different durations of ETI pause to assess its impact. During the study, participants will undergo repeated urine and blood tests to measure urine bicarbonate excretion, ETI plasma levels, acid-base balance, and electrolyte changes at multiple time points including 12, 36, and 60 hours after pausing ETI and after restarting the therapy. The total study duration varies per participant, and safety monitoring will be conducted. This research is sponsored by the University of Aarhus to better understand kidney effects of ETI treatment in CF patients.
CONDITIONS
Brief Title
Cystic Fibrosis in the Kidney: Monitoring the Effectiveness of Elexacaftor/tezacaftor/ivacaftor in Urine After a Short Pause of Therapy
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adult (age >17 years) cystic fibrosis patients
- Normal kidney function estimated by eGFR greater than 90
- Adults capable of understanding and voluntarily consenting
You will not qualify if you...
- Critical acute illness
- Severe lung disease with ppFEV1 less than 40%
- Adults not capable of understanding and voluntarily consenting
AI-Screening
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Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Up to 60 hours depending on assigned ETI pause duration
Participants undergo a short pause of their Elexacaftor/tezacaftor/ivacaftor (ETI) therapy lasting 12, 36, or 60 hours to monitor changes in urine bicarbonate and plasma concentrations.
Visits at baseline, after 12/36/60 hours of therapy pause, and after therapy is resumed
Trial Site Locations
Total: 1 location
1
Department of Infectious Diseases, Aarhus University Hospital
Aarhus C, Central Jutland, Denmark, 8000
Actively Recruiting
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Research Team
A
Amalie Q. Rousing, BM
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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Published Research Related To This Trial
Challenged Urine Bicarbonate Excretion as a Measure of Cystic Fibrosis Transmembrane Conductance Regulator Function in Cystic Fibrosis.
Peder Berg, Mads V Sorensen, Amalie Quist Rousing...
https://pubmed.ncbi.nlm.nih.gov/36315944