Phase 3 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:

• You have been newly diagnosed with, or are experiencing a return of, a condition called ANCA-associated vasculitis — specifically granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) — and your disease is currently active (confirm with trial site)
• Your urine tests show signs of kidney involvement, including protein and blood in the urine, and your kidneys are still functioning at a certain minimum level (confirm with trial site)
• You have had a kidney biopsy within the last 4 weeks that confirms the disease is affecting your kidneys
• You are between 18 and 80 years old
• You are willing and able to give written consent to take part in the study
• You are covered by the French health insurance system

Who may not be able to join:

• You are currently experiencing severe bleeding in your lungs that requires breathing support from a machine
• You have a related but different condition called eosinophilic granulomatosis with polyangiitis (also known as Churg-Strauss syndrome)
• You have had an active cancer (other than a common type of non-serious skin cancer) in the past 2 years
• You currently have a serious active infection caused by bacteria, a virus, or a fungus
• You have ever had cancer of the bladder or urinary tract
• You have a history of severe heart failure symptoms (confirm with trial site)
• You have had moderate heart failure symptoms in the past 3 months, or a recent heart scan showed your heart is pumping weakly (confirm with trial site)
• Your liver enzyme levels were significantly raised in the past month, or you have a serious long-term liver condition
• You tested positive for HIV, hepatitis B, or have an active hepatitis C infection
• A recent blood test showed your white blood cell count (a type called neutrophils) is very low (confirm with trial site)
• You have previously had a bad reaction or intolerance to a drug called Pioglitazone (or similar drugs in the same family), or to Rituximab, or to any of the ingredients in these medicines
• You have ever had a serious complication of diabetes called diabetic ketoacidosis
• You have, or are at high risk of developing, a condition affecting the back of your eye called macular edema (an eye specialist would need to confirm this)
• You are pregnant, breastfeeding, or planning to become pregnant within the next 2 years; women who could become pregnant must use highly effective contraception throughout the study and for 12 months after it ends
• You have a severe neurological or psychiatric condition, such as dementia or schizophrenia
• You have previously had a kidney transplant
• You have received certain immune-suppressing medicines (such as cyclophosphamide or high-dose rituximab) within the past 6 months, or are currently taking certain other immune-suppressing drugs without stopping them first (confirm with trial site)
• You have received a large dose of steroid medication through a drip in the past 4 weeks (confirm with trial site)
• You have been taking more than a low daily dose of steroid tablets continuously for more than 6 weeks before joining the study (confirm with trial site)
• You are currently taking part in another clinical trial that involves a treatment or intervention
• You are under legal guardianship or are a legally protected adult
• You are unable to understand or follow the study procedures
• You receive State Medical Assistance in France (Aide Médicale de l'État)

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