NCT06364176 Targeting Inflammation With Losartan to Improve Response to Modulator Therapy in Cystic Fibrosis.
| NCT ID | NCT06364176 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Kansas Medical Center |
| Condition | Cystic Fibrosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 42 participants |
| Start Date | 2024-06-03 |
| Primary Completion | 2027-05 |
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.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 42 participants in total. It began in 2024-06-03 with a primary completion date of 2027-05.
⚠ 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
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Prior lung transplant * BMI \<18 * CF pulmonary exacerbation requiring hospitalization or intravenous antibiotics in the preceding 30 days * 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 * Chronic renal insufficiency (creatinine clearance \<45 ml/min) * Pregnancy or lactation * Inability or unwillingness to comply with approved contraceptive method during the study period (females of childbearing age) * 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 * Participation in another interventional trial that, in the opinion of the investigator, has the potential to affect the primary outcome
Contact & Investigator
Charles Bengtson, MD, MSc
PRINCIPAL INVESTIGATOR
University of Kansas Medical Center
Frequently Asked Questions
Who can join the NCT06364176 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, studying Cystic Fibrosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06364176 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06364176 currently recruiting?
Yes, NCT06364176 is actively recruiting participants. Contact the research team at hhellwig@kumc.edu for enrollment information.
Where is the NCT06364176 trial being conducted?
This trial is being conducted at Kansas City, United States.
Who is sponsoring the NCT06364176 clinical trial?
NCT06364176 is sponsored by University of Kansas Medical Center. The principal investigator is Charles Bengtson, MD, MSc at University of Kansas Medical Center. The trial plans to enroll 42 participants.