Phase 3 Vasculitis 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:

• You must be between 2 and 17 years old at the time of signing the consent forms
• You must have been on a stable, maximum-tolerated dose of certain blood pressure/kidney-protecting medications (called RASI, such as ACE inhibitors or ARBs) for at least 3 months before the screening period, with no planned changes for the duration of the study (confirm with trial site)
• Your urine must show a certain level of protein detected through three morning urine samples collected within one week during screening (confirm with trial site)
• Your kidneys must be functioning at a minimum level, measured by a kidney function test called eGFR (confirm with trial site)
• You must have received vaccines against meningococcal infection, Haemophilus influenzae type b, and Streptococcus pneumoniae
• If you are already taking certain other medications (such as SGLT2 inhibitors or GLP-1 agonists), you must have been on a stable, maximum-tolerated dose for at least 3 months before screening, with no planned changes for part of the study (confirm with trial site)
• You must have an confirmed diagnosis of primary IgA nephropathy (a specific kidney disease), proven by a kidney biopsy taken within the past 3 years or during the screening period

Who may not be able to join:

• People diagnosed with a rapidly worsening form of kidney inflammation
• People whose IgA nephropathy is caused by another underlying condition, rather than being the primary disease
• People who have another significant kidney disease alongside IgA nephropathy
• People whose IgA nephropathy is currently in remission or has significantly improved in the last 6 months
• People with poorly controlled diabetes (confirmed by a blood sugar test showing HbA1c above 8.5%)
• People who have had a kidney transplant in the past or are planning one during the main study period
• People who have had a transplant of another major organ (such as heart, lung, liver, or pancreas) or a bone marrow transplant
• People who have had their spleen removed or whose spleen does not work properly
• People with a severe protein-loss kidney condition currently needing albumin infusions, or who have needed emergency dialysis in the last 6 months
• People who have ever been diagnosed with haemolytic uremic syndrome (a serious blood and kidney condition)
• People who are planning urological surgery during the study that could affect kidney function
• People born with an immune system deficiency
• People who have had an active serious bacterial, viral, or fungal infection within the 14 days before joining the study
• People who have received biologic medications (a type of specialist drug treatment) for IgA nephropathy within the 6 months before screening

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