NCT06364176RecruitingPhase 2
Targeting Inflammation With Losartan to Improve Response to Modulator Therapy in Cystic Fibrosis.
Targeting Inflammation With Losartan to Improve Response to Modulator Therapy in Cystic Fibrosis
Source: ClinicalTrials.gov · Last updated 2 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The goal of this clinical trial is to test use of losartan in those with cystic fibrosis (CF) on modulator therapy. The main question it aims to answer is if treatment with losartan improves response of the CF transmembrane conductance regulator (CFTR) channel to modulator therapy. Participants will be asked take losartan or placebo for twelve weeks and will have changes in sweat chloride levels measured as a marker of CFTR function.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 42 (estimated)
- First submitted
- 6 Mar 2024
- Start date
- 3 Jun 2024
- Primary completion date
- May 2027
- Lead sponsor
- University of Kansas Medical Center
- Diseases
- Cystic fibrosis
- NCT number
- NCT06364176
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 42
- From 3 Jun 2024 to the primary completion date, May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior lung transplant
- Systemic corticosteroid or regular non-steroidal anti-inflammatory use in the preceding 30 days
- Chronic use of angiotensin receptor blockers or angiotensin converting enzyme inhibitors
- Concomitant use of medications known to interact with losartan, including aliskiren
Lab values
- Chronic renal insufficiency (creatinine clearance \<45 ml/min)
- In the opinion of the investigator any severe or acute or chronic condition or laboratory abnormality that may increase the risk associated with trial participation or make the participant inappropriate for enrollment
Age
- Inability or unwillingness to comply with approved contraceptive method during the study period (females of childbearing age)
Other
- BMI \<18
- CF pulmonary exacerbation requiring hospitalization or intravenous antibiotics in the preceding 30 days
- Pregnancy or lactation
- Participation in another interventional trial that, in the opinion of the investigator, has the potential to affect the primary outcome
Who the study is looking for
- Established diagnosis of cystic fibrosis
- Age 12 years and older
- Stable use of elexacaftor/tezacaftor/ivacaftor for 90 days prior to enrollment
- Sweat chloride concentration 50 mmol/L or greater while on elexacaftor/tezacaftor/ivacaftor
Age in the registry: 12 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Kansas Medical Center Coordinator of this site? Confirm its status | Kansas City | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.