RECRUITING

Targeting Inflammation With Losartan to Improve Response to Modulator Therapy in Cystic Fibrosis.

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Conditions

Cystic Fibrosislosartan

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Targeting Inflammation With Losartan to Improve Response to Modulator Therapy in Cystic Fibrosis

Quick Facts

Study Start:2024-06-03
Study Completion:2027-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06364176

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Established diagnosis of cystic fibrosis
  2. * Age 12 years and older
  3. * Stable use of elexacaftor/tezacaftor/ivacaftor for 90 days prior to enrollment
  4. * Sweat chloride concentration 50 mmol/L or greater while on elexacaftor/tezacaftor/ivacaftor
  1. * Prior lung transplant
  2. * BMI \<18
  3. * CF pulmonary exacerbation requiring hospitalization or intravenous antibiotics in the preceding 30 days
  4. * Systemic corticosteroid or regular non-steroidal anti-inflammatory use in the preceding 30 days
  5. * Chronic use of angiotensin receptor blockers or angiotensin converting enzyme inhibitors
  6. * Concomitant use of medications known to interact with losartan, including aliskiren
  7. * Chronic renal insufficiency (creatinine clearance \<45 ml/min)
  8. * Pregnancy or lactation
  9. * Inability or unwillingness to comply with approved contraceptive method during the study period (females of childbearing age)
  10. * 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
  11. * Participation in another interventional trial that, in the opinion of the investigator, has the potential to affect the primary outcome

Contacts and Locations

Study Contact

Heidi Hellwig
CONTACT
9135886045
hhellwig@kumc.edu
Carolina Aguiar
CONTACT
9139459295
caguiar@kumc.edu

Principal Investigator

Charles Bengtson, MD, MSc
PRINCIPAL_INVESTIGATOR
University of Kansas Medical Center

Study Locations (Sites)

University of Kansas Medical Center
Kansas City, Kansas, 66160
United States

Collaborators and Investigators

Sponsor: University of Kansas Medical Center

  • Charles Bengtson, MD, MSc, PRINCIPAL_INVESTIGATOR, University of Kansas Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-03
Study Completion Date2027-10

Study Record Updates

Study Start Date2024-06-03
Study Completion Date2027-10

Terms related to this study

Keywords Provided by Researchers

  • losartan

Additional Relevant MeSH Terms

  • Cystic Fibrosis