Monitoring kidney function in cystic fibrosis patients during a treatment pause
Cystic Fibrosis in the Kidney: Monitoring the Effectiveness of Elexacaftor/tezacaftor/ivacaftor in Urine After a Short Pause of Therapy
NA · University of Aarhus · NCT05818319
This study is testing how a short break from a specific cystic fibrosis treatment affects kidney function in adults with the condition.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Aarhus (other) |
| Locations | 1 site (Aarhus C, Central Jutland) |
| Trial ID | NCT05818319 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 17 years with cystic fibrosis and normal kidney function.
Not a fit: Patients with critical acute illness or severe lung disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into kidney function in cystic fibrosis patients and improve treatment strategies.
How similar studies have performed: While the specific approach of monitoring urine HCO3- excretion in this context may be novel, related studies on CFTR modulation have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Aarhus C, Central Jutland
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cystic Fibrosis, CFTR Gene Mutation