A Phase 3 Trial of the Efficacy and Safety of Bardoxolone Methyl in Patients with Autosomal Dominant Polycystic Kidney Disease

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Chronic Kidney Disease And Autosomal Dominant Polycystic Kidney Disease
  • Age: Between 18 - 70 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Diagnosis of ADPKD by based on cyst count
    2. Able to swallow capsules
    3. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
    4. Willing and able to sign informed consent document

You may not be eligible for this study if the following are true:

    1. Prior exposure to bardoxolone methyl
    2. Concomitant use of tolvaptan is excluded
    3. History of administration of polycystic kidney disease-modifying agents
    4. History of clinically significant left-sided heart disease and/or clinically significant cardiac disease
    5. History of malignancy within 5 years
    6. Systemic immunosuppression for more than 2 weeks, cumulatively, within the 12 weeks prior to randomization or anticipated need for immunosuppression during the study
    7. Untreated or uncontrolled active bacterial, fungal, or viral infection
    8. Participation in other interventional clinical studies
    9. Unwilling to practice acceptable methods of birth control during Screening, while taking study drug, and for at least 30 days after the last dose of study drug is ingested
    10. Women who are pregnant or breastfeeding
    11. Known hypersensitivity to any component of the study drug
    12. Any abnormal laboratory level that, in the opinion of the investigator, would put the patient at risk by trial enrollment
    13. In the opinion of the investigator, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason
    14. Coronavirus disease 2019 (COVID-19) diagnosis within 6 months prior



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