Monitoring kidney function in cystic fibrosis patients during a treatment pause

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the impact of a short pause in treatment with the CFTR modulator combination therapy Elexacaftor/tezacaftor/ivacaftor on urine bicarbonate excretion in adult cystic fibrosis patients. The researchers aim to determine if changes in urine HCO3- excretion can serve as a biomarker for CFTR function and the effectiveness of the therapy. Participants will undergo a treatment pause of varying durations to assess these changes. The study focuses on understanding the relationship between CFTR dysfunction and kidney function in cystic fibrosis.

Why it matters

Who can join: the full rules

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.

Where it's running

• Department of Infectious Diseases, Aarhus University Hospital
  Aarhus C, Central Jutland, Denmark Recruiting

Study contacts

• Principal investigator: Jens G. Leipziger — Department of Biomedicine, Aarhus University, Denmark
• Study coordinator: Amalie Q. Rousing, BM
• Email: arousing@biomed.au.dk

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.