Phase 2 Chronic Kidney Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People from birth up to age 5 are currently being enrolled (the trial notes that only participants under 6 years of age are being accepted at this time).
• People who have been formally diagnosed with a condition called Primary Hyperoxaluria Type 1 (PH1), confirmed through genetic testing.
• People whose kidneys are functioning at a significantly reduced level (a specific blood test result below a certain threshold — confirm with trial site).
• People whose blood oxalate levels (a naturally occurring substance in the body) are above a certain level measured during the screening period.
• People who are on kidney dialysis (either hemodialysis or peritoneal dialysis), provided they have been on dialysis for less than 24 months and their dialysis routine has been stable for at least 2 weeks before screening.
• Male or female participants of any sex.
• Male participants must agree to use contraception during treatment and for at least 12 weeks after the last dose, and must agree not to donate sperm during this time.
• Female participants must not be pregnant or breastfeeding, and must either not be of childbearing potential, or agree to use contraception during treatment and for at least 12 weeks after the last dose, and agree not to harvest or freeze eggs during this time.
• The participant, or their parent or legal guardian if they are under 18, must be able to give signed informed consent agreeing to the study requirements.
• Participants aged 12 to under 18 must be able to provide their own written agreement to take part.
• For children under 12, agreement to participate will follow local rules and regulations.
• People who are covered by a health insurance system, where this is required by local regulations.

Who may not be able to join:

• People who have previously had a liver transplant, or who have a liver transplant scheduled within 6 months of starting the trial (previous kidney transplants are allowed).
• People who have documented serious complications of oxalate build-up throughout the body, such as calcium deposits in the eyes, heart, or skin, or a history of severe bone pain, bone fractures, or bone deformities related to this condition.
• People with certain other health conditions that could affect safety or interfere with the study, including serious ongoing illness, known active liver disease, kidney problems unrelated to PH1, or concerns about heavy alcohol or drug use.
• People who have used a specific type of medication called an RNAi drug (including the study drug DCR-PHXC) within the last 6 months.
• People who have previously had serious reactions to a type of treatment called oligonucleotide-based therapy, such as very low platelet counts, liver injury, severe flu-like symptoms, severe skin reactions at the injection site, or significant problems with blood clotting.
• People who have taken part in another clinical trial using an investigational (unapproved) medicine other than DCR-PHXC within 4 months before screening.
• People whose liver function blood test results are above a certain level, indicating possible liver stress (confirm with trial site).
• People who test positive for a specific immune marker called anti-dsDNA antibody at screening.
• People who are known to be allergic or sensitive to the study drug DCR-PHXC or any of its ingredients.
• People who are unable or unwilling to follow the study procedures and lifestyle requirements.

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