NCT05818319 Cystic Fibrosis in the Kidney: Monitoring the Effectiveness of Elexacaftor/tezacaftor/ivacaftor in Urine After a Short Pause of Therapy
| NCT ID | NCT05818319 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Aarhus |
| Condition | Cystic Fibrosis (CF) |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2023-06-01 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2023-06-01 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Amalie Q. Rousing, BM
✉ arousing@biomed.au.dkJens G. Leipziger
PRINCIPAL INVESTIGATOR
Department of Biomedicine, Aarhus University, Denmark
Frequently Asked Questions
Who can join the NCT05818319 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cystic Fibrosis (CF). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05818319 currently recruiting?
Yes, NCT05818319 is actively recruiting participants. Contact the research team at arousing@biomed.au.dk for enrollment information.
Where is the NCT05818319 trial being conducted?
This trial is being conducted at Aarhus C, Denmark.
Who is sponsoring the NCT05818319 clinical trial?
NCT05818319 is sponsored by University of Aarhus. The principal investigator is Jens G. Leipziger at Department of Biomedicine, Aarhus University, Denmark. The trial plans to enroll 30 participants.