Recruiting
Phase 2

Losartan with Modulator

Sponsor:

University of Kansas Medical Center

Code:

NCT06364176

Conditions

Cystic Fibrosis

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

Interventions

Losartan

Placebo

Study Details

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.

Conditions

Cystic Fibrosis

Study ID

NCT06364176

Start date

Jun 3, 2024

Status verified date

Apr, 2025

Completion date

Oct, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

42 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Losartan

Losartan 25mg twice daily for one week followed by 50mg twice daily through week 12.

placebo comparator: Placebo

Placebo twice daily through week 12

Interventions

Losartan

Treatment with losartan through week 12

Placebo

Treatment with placebo through week 12

Primary outcome measure

  • Sweat chloride [ Time Frame: Baseline through week 12 ]

Central Contacts and Locations

Central contacts

Heidi Hellwig

9135886045hhellwig@kumc.edu

Carolina Aguiar

9139459295caguiar@kumc.edu

Locations

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Charles Bengtson, MD, MSc

913-588-6000

Carolina Aguiar

9139459295

More Information

Sponsor

University of Kansas Medical Center

Last update posted

May 2, 2025

Last verified

Apr, 2025

Keywords

  • losartan

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Kansas Medical Center on 2025-05-02.