Phase 2 Vasculitis Trial, Recruiting

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

Who might be able to join this trial:

Criteria that apply to all groups:

• The person (or their parent or legal guardian, if appropriate) is willing and able to sign a consent form before any screening tests take place.
• The person's kidneys are functioning at a level of 30 or above on a standard kidney function measurement taken at screening.
• The person's blood pressure falls within the normal range for their sex and height.

Additional criteria for Group 1 (children with FSGS or MCD):

• The person is at least 1 year old at screening and under 18 years old at the start of the study.
• The person has a high level of protein in their urine (at a specific threshold) at screening, AND meets at least one of the following: a kidney biopsy showing FSGS or MCD consistent with a primary cause, despite past or current treatment with steroids or immune-suppressing medicines; OR a confirmed genetic change in a kidney cell protein linked to FSGS or MCD (no biopsy required in this case); OR a kidney biopsy showing FSGS linked to a non-immune, adaptive cause.

Additional criteria for Group 2 (children with IgAN, IgAV, or Alport Syndrome):

• The person is at least 2 years old at screening and under 18 years old at the start of the study.
• The person has a moderately elevated level of protein in their urine (at a specific threshold) at screening, AND has a confirmed diagnosis of IgA nephropathy, IgA vasculitis, or Alport Syndrome — either through a kidney biopsy or through genetic testing showing specific gene changes linked to Alport Syndrome.

Additional criteria for Group 3 (children with IgAN, specific treatment history):

• The person is at least 8 years old at screening and under 18 years old at the start of the study.
• The person has a high level of protein in their urine (at a specific threshold) at screening, AND has a kidney biopsy confirming IgA nephropathy.
• The person weighs at least 40 kg.
• The person has been taking a specific type of blood-pressure-related kidney-protective medication (an ACE inhibitor and/or ARB) for at least 12 weeks before screening.

Who may not be able to join:

• People who weigh less than 7.3 kg at screening.
• People whose FSGS or MCD was caused by a viral infection, medication side effects, or cancer.
• People who have IgA deposits in their kidneys caused by another condition (such as lupus or liver cirrhosis), rather than primary IgA nephropathy or IgA vasculitis.
• People who have had a sudden onset of kidney disease, a diagnostic biopsy, or a flare of kidney disease requiring a new or different immune-suppressing treatment in the 6 months before screening.
• People taking long-term immune-suppressing medications (including steroid tablets) who have not been on a stable dose for at least 1 month before screening.
• People who need to take any medications that are listed as prohibited in the study rules.
• People who have had an organ transplant (except for corneal transplants).
• People with a documented history of heart failure of a certain severity, or who have previously been hospitalised for heart failure, or who have unexplained symptoms such as shortness of breath, fluid build-up, or leg swelling.
• People with a significant heart valve problem.
• People with a clinically significant blood vessel condition present from birth.
• People with jaundice, hepatitis, or known liver or bile duct disease, or whose liver enzyme levels are more than twice the normal upper limit at screening.
• People with a history of cancer in the past 2 years.
• People with a low red blood cell level (below specific thresholds for haematocrit or haemoglobin) at screening.
• People with a potassium blood level that is too high (above a specific threshold) at screening.
• People with any other abnormal blood test results that the investigator considers medically significant.
• People who have previously had an allergic reaction to a class of blood pressure medication called angiotensin II antagonists or endothelin receptor antagonists, including the study drug sparsentan, or who are allergic to any ingredient in the study medication.
• People who are pregnant, planning to become pregnant during the study, or currently breastfeeding.
• Female participants who have begun menstruating and who are able to become pregnant, and who do not agree to use a highly reliable form of contraception (with a failure rate of less than 1% per year) starting 7 days before the first dose until 28 days after the last dose, plus an additional barrier method during vaginal sexual activity. Negative pregnancy tests will also be required at specific points throughout the study. (Before menstruation begins, pregnancy testing and contraception are not required, but the participant and their parent or guardian must be informed that these requirements will begin immediately once menstruation starts.)
• People who have taken part in another clinical drug study within 28 days before screening, or who plan to do so during this study.
• People who have previously taken the study drug sparsentan.
• People who, in the investigator's opinion, are unlikely to be able to follow the study requirements — for example, due to a history of not following medical instructions.
• For Group 3 only: people who are unable to swallow tablets whole.

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