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:

• Adults aged 18 or older of any race or ethnicity who have been assessed as not frail (below a score of 7 on a standard frailty scale) in the 3 months before developing the kidney condition being studied, which is a rapidly worsening kidney disease (RPGN) linked to a condition called ANCA-associated vasculitis (AAV)
• People who are willing and able to follow the study requirements and agree in writing to take part
• People who are willing to have a kidney tissue sample (biopsy) taken before a certain point in the study, or who have had one taken within the past 45 days
• People newly diagnosed with this rapidly worsening kidney condition within the past 45 days, where kidney function has declined to a specific level (confirm with trial site), and where there is evidence of protein or blood in the urine linked to this illness
• People who have a positive blood test for specific antibodies (called ANCA — either MPO or PR3 type) that support the diagnosis
• People who weigh 130 kg or less
• Women who are not pregnant or breastfeeding, and who either cannot become pregnant or agree to use a reliable form of contraception during the study and for a set period after the last dose of study medication
• Women who agree not to donate eggs for at least 6 months after the last dose of study medication
• Men who agree to use contraception (abstinence or condoms) during the study and for 90 days after the last dose of study medication
• Men who agree not to donate sperm during the study and for 90 days after the last dose of study medication

Who may not be able to join:

• People who have had this same type of rapidly worsening kidney disease before and recovered, meaning the current episode would be considered a relapse
• People who test positive for a different type of kidney-attacking antibody (anti-GBM antibody)
• People who have active or latent (hidden) tuberculosis, as shown by a specific TB blood test or, where that test is unavailable, by chest imaging
• People who have an ongoing infection that could be made worse by the kidney disease or its standard treatment
• People with active hepatitis B, hepatitis C, or HIV infection
• People who have taken any medications that are not allowed under the study rules
• People who have already received more than a certain high amount of steroid treatment for this kidney condition (confirm specific thresholds with trial site)
• People who have been treated with, or are planned to be treated with, a specific medication called avacopan
• People with poor vein access (making it difficult to give medications or take blood samples by injection)
• People who have taken part in another clinical trial and received an experimental treatment within the past 30 days (or longer, depending on the treatment type — up to 90 days for certain biological drugs)
• People with a history of certain skin conditions (such as psoriasis, very dry skin, recurrent eye inflammation, scleroderma, or vitiligo) that required a doctor-prescribed treatment, unless those skin issues are known to be directly caused by AAV
• People diagnosed with a condition where lupus and AAV overlap
• People diagnosed with a specific type of vasculitis called eosinophilic granulomatosis with polyangiitis
• People with serious, uncontrolled disease affecting the lungs, heart, liver, hormonal system, nervous system, or kidneys that is unrelated to the condition being studied, or any other condition the study doctor believes makes participation unsafe
• People who received a live vaccine within 30 days before the screening visit
• People who received any vaccine within 7 days before the first dose of study medication, except for flu or pneumococcal vaccines
• People who work for the study doctor or the study site, are directly involved in running the study, or are a family member of study site staff
• People who have not yet fully recovered from complications of major surgery before starting the study medication
• People with a known history of alcohol or drug misuse within the past year, or who test positive for drugs of abuse at screening
• People diagnosed with cancer in the past 5 years, other than certain types of early-stage skin cancer
• People who have lung bleeding along with low blood oxygen levels (below 85%) or who need breathing support through a machine
• People who have needed dialysis within the 7 days before screening
• People who have had a plasma exchange procedure within 7 days before the first dose of study medication
• People who have a known allergy to the study drug or any of its ingredients

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