Phase 2 Cystic Fibrosis Trial, Recruiting NCT04530383 Sponsor: University of Kansas Medical Center Condition: Cystic Fibrosis
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Phase 2 Cystic Fibrosis Trial, Recruiting

NCT04530383
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are over 18 years old and have been diagnosed with cystic fibrosis (CF)
  • You have been taking one of these CF medications for at least 30 days before the start of the study: ivacaftor, elexacaftor/tezacaftor/ivacaftor, or vanzacaftor/tezacaftor/deutivacaftor
  • You have been diagnosed with CF-related diabetes (CFRD) and still have blood sugar problems at least 6 months after starting one of the above CF medications, shown by at least one of the following: currently using insulin, a long-term blood sugar test (HbA1c) above 6.5%, a fasting blood sugar level above 126 mg/dl, or a blood sugar level above 200 mg/dl taken at any time or during a sugar-drink test

Who may not be able to join:

  • You have previously had a lung or liver transplant
  • You currently need extra oxygen to breathe
  • Your Body Mass Index (BMI) is below 18 (considered underweight)
  • You were hospitalised or received antibiotic drips for a CF lung flare-up in the past 30 days
  • You have taken steroid tablets or regular anti-inflammatory pain medications (such as ibuprofen) in the past 30 days
  • You have significant heart, kidney, nerve, mental health, hormonal, or cancer-related conditions that could interfere with taking part in the study (confirm with trial site)
  • Your liver function blood test results are significantly above the normal range, or your bilirubin level is above 3 mg/dL
  • You are currently taking medications that are known to interact with metformin (confirm with trial site)
  • You have a Vitamin B12 deficiency
  • You are currently pregnant or breastfeeding
  • You are a woman of childbearing age and are unwilling or unable to use an approved form of contraception during the study
  • You are taking certain medications that strongly affect how the body processes drugs (known as strong CYP inducers or moderate-to-strong CYP inhibitors) (confirm with trial site)
  • The study doctor believes you have any serious condition or abnormal test result that could put you at risk or make the study unsuitable for you
  • You are already taking part in another clinical trial that could affect this study's results

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 23 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Matthias A Salathe, M.D., Professor

Phone: 9135886000

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
University of Kansas Medical Center
Registry
ClinicalTrials.gov
Start date
14 February 2022
Est. completion
30 December 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in BK channel gene expression

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov