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Cystic Fibrosis in the Kidney: Monitoring the Effectiveness of Elexacaftor/tezacaftor/ivacaftor in Urine After a Short Pause of Therapy

RecruitingNAAges 18 Years - anyAllUniversity of Aarhus
NCT05818319 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Adult (age \>17 years) CF patients. * Normal kidney function estimated by eGFR\>90. * Adults capable of understanding and voluntarily consenting. Exclusion Criteria: * Critical acute illness. * Severe lung disease (ppFEV1\<40%). * Adults not capable of understanding and voluntarily consenting.
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What it tests

  • 12 hours ETI pause
  • 36 hours ETI pause
  • 60 hours ETI pause
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Where

1 site
Department of Infectious Diseases, Aarhus University Hospital
Aarhus C, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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