Cystic Fibrosis in the Kidney: Monitoring the Effectiveness of Elexacaftor/tezacaftor/ivacaftor in Urine After a Short Pause of Therapy
NCT ID: NCT05818319
Last Updated: 2025-02-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
30 participants
INTERVENTIONAL
2023-06-01
2025-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) in Cystic Fibrosis Subjects Without an F508del Mutation
NCT05274269
Study to Evaluate Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) Long-term Safety and Efficacy in Subjects Without F508del
NCT05331183
A Study Evaluating Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis and F/MF Genotypes
NCT04353817
Population Pharmacokinetics of Elexacaftor-tezacaftor-ivacaftor in a Paediatric Population
NCT07303621
Daily Monitoring of Respiratory Symptoms and Spirometry During ETI Treatment in Persons With Cystic Fibrosis.
NCT05599230
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
CF patients will be randomly allocated to an ETI treatment pause for either 12, 36, or 60 hours. Treatment will be resumed immediately after the pause is finished.
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
12 hours ETI pause
12 hours ETI pause
Patients with CF are randomly allocated to ETI pause lasting 12 hours.
36 hours ETI pause
36 hours ETI pause
Patients with CF are randomly allocated to ETI pause lasting either 36 hours.
60 hours ETI pause
60 hours ETI pause
Patients with CF are randomly allocated to ETI pause lasting either 60 hours.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
12 hours ETI pause
Patients with CF are randomly allocated to ETI pause lasting 12 hours.
36 hours ETI pause
Patients with CF are randomly allocated to ETI pause lasting either 36 hours.
60 hours ETI pause
Patients with CF are randomly allocated to ETI pause lasting either 60 hours.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Normal kidney function estimated by eGFR\>90.
* Adults capable of understanding and voluntarily consenting.
Exclusion Criteria
* Severe lung disease (ppFEV1\<40%).
* Adults not capable of understanding and voluntarily consenting.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Aarhus
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jens G. Leipziger
Role: PRINCIPAL_INVESTIGATOR
Department of Biomedicine, Aarhus University, Denmark
Majbritt Jeppesen
Role: PRINCIPAL_INVESTIGATOR
Department of Infectious Diseases, Aarhus University Hospital, Denmark
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Infectious Diseases, Aarhus University Hospital
Aarhus C, Central Jutland, Denmark
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Amalie Rousing
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Berg P, Svendsen SL, Sorensen MV, Larsen CK, Andersen JF, Jensen-Fangel S, Jeppesen M, Schreiber R, Cabrita I, Kunzelmann K, Leipziger J. Impaired Renal HCO3- Excretion in Cystic Fibrosis. J Am Soc Nephrol. 2020 Aug;31(8):1711-1727. doi: 10.1681/ASN.2020010053. Epub 2020 Jul 23.
Berg P, Sorensen MV, Rousing AQ, Vebert Olesen H, Jensen-Fangel S, Jeppesen M, Leipziger J. Challenged Urine Bicarbonate Excretion as a Measure of Cystic Fibrosis Transmembrane Conductance Regulator Function in Cystic Fibrosis. Ann Intern Med. 2022 Nov;175(11):1543-1551. doi: 10.7326/M22-1741. Epub 2022 Nov 1.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CFPT29092022
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.