Evaluating Pioglitazone to Improve Kidney Health in ANCA-associated Vasculitis A Multicenter Randomized Phase 3 Trial

What this Trial Is About

Researchers are evaluating the use of pioglitazone to improve kidney outcomes in people with ANCA-associated vasculitis, a condition that affects blood vessels and involves kidney inflammation. This multicenter, randomized controlled trial includes patients with biopsy-confirmed kidney involvement of ANCA vasculitis at diagnosis. The study aims mainly to see if pioglitazone can reduce kidney damage by improving protein levels in urine and serum creatinine. It also examines effects on blood pressure, metabolic changes from steroids, vasculitis activity, and safety in this group of patients. All participants receive standard immunosuppressive treatment combining corticosteroids and rituximab. They are randomly assigned to take either pioglitazone 30 mg daily or a placebo for 26 weeks alongside the standard care. Rituximab is given weekly for four weeks as induction, then re-administered every six months. Participants follow a predefined steroid tapering schedule. Biological samples are collected at multiple points throughout the study for analysis. Participants are followed for a total of 52 weeks with visits scheduled at weeks 1, 2, 3, 4, 8, 12, 26, 38, and 52. During these visits, kidney function, proteinuria, vasculitis activity, quality of life, and safety are assessed through clinical exams, blood and urine tests, and questionnaires. The primary outcome is measured at week 26, and secondary outcomes continue through week 52 to monitor effects and safety of pioglitazone over time.

A Trial to Evaluate the Efficacy of Pioglitazone to Promote Renal Tolerance in ANCA-associated Vasculitis - RENATO Trial