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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Adult (age \>17 years) CF patients. - Normal kidney function estimated by eGFR\>90. - Adults capable of understanding and voluntarily consenting. Who Should NOT Join This Trial: - Critical acute illness. - Severe lung disease (ppFEV1\<40%). - Adults not capable of understanding and voluntarily consenting. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

OTHER

12 hours ETI pause

Patients with CF are randomly allocated to ETI pause lasting 12 hours.

OTHER

36 hours ETI pause

Patients with CF are randomly allocated to ETI pause lasting either 36 hours.

OTHER

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