A Phase 2 Open-Label Study to Evaluate the Safety and Efficacy of DCR-PHXC in Patients With Primary Hyperoxaluria Type 1 or 2 and Severe Renal Impairment With or Without Dialysis

Are you eligible to participate in this study?

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

  • Conditions:
    Primary Hyperoxaluria Type 1 Or 2
  • Age: Between 0 - 80 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Documented diagnosis of Primary Hyperoxaluria Type 1 (PH1) or Type 2 (PH2), confirmed by genotyping
    2. For participants receiving hemodialysis or peritoneal dialysis, total duration of hemodialysis or peritoneal dialysis must be less than or equal to 18 months and hemodialysis or peritoneal dialysis regimen must have been stable for at least 3 months
    3. A male participant with a female partner of childbearing potential must agree to use contraception
    4. A female participant is eligible to participate if she is not pregnant, not breastfeeding, not childbearing potential or agrees to follow contraceptive guidance as per protocol

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

    1. Prior hepatic transplantation; or scheduled transplantation within 6 months
    2. Known history of severe systemic oxalosis
    3. Presence of any condition or comorbidities that would interfere with study compliance or data interpretation or potentially impact patient safety
    4. Use of an RNAi drug, other than DCR-PHXC
    5. History of one or more of the following reactions to an oligonucleotide-based therapy:
      • Severe thrombocytopenia
      • Hepatotoxicity
      • Severe flu-like symptoms
      • Localized skin reaction
      • Coagulopathy/clinically significant prolongation of clotting time
    6. Participation in any clinical study in which they received an investigational medicinal product
    7. Liver function test abnormalities
    8. Positive anti-double-stranded deoxyribonucleic acid (anti-dsDNA) antibody test
    9. Known hypersensitivity to DCR-PHXC or any of its ingredients
    10. Inability or unwillingness to comply with the specified study procedures



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