What is pioglitazone studying for ANCA-associated vasculitis?

Pioglitazone is being studied to see if it can help reduce kidney damage in patients with ANCA-associated vasculitis. The trial evaluates whether adding pioglitazone to standard treatment improves kidney function and lowers protein in urine. This research is sponsored by Assistance Publique - Hôpitaux de Paris and aims to find better ways to protect the kidneys during vasculitis treatment.

Who may be eligible for this ANCA-associated vasculitis clinical trial?

Adults aged 18 to 80 years with biopsy-confirmed kidney involvement of ANCA-associated vasculitis may be eligible. Participants must have active disease with specific kidney function and proteinuria levels, and be affiliated with a French health insurance system. People with certain heart, liver, or infectious conditions, recent cancer, or pregnancy are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this ANCA-associated vasculitis clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or accommodation costs.

Actively Recruiting

Phase 3

Age: 18Years - 80Years

All Genders

ID05946564

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

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-07-01

126

Participants Needed

Research Sites

27 weeks

Total Duration

AI-Summary

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.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 80Years

All Genders

Eligibility Criteria

You may qualify if you...

Newly diagnosed or relapsing ANCA-associated vasculitis (GPA or MPA) with active disease (BVAS ≥3)
Proteinuria (UPCR >300 mg/g), haematuria (>10 RBC/hpf), and eGFR ≥15 mL/min/1.73 m2 within 1 month prior to inclusion
Recent renal biopsy (<4 weeks) confirming active kidney involvement
Age between 18 and 80 years
Written informed consent prior to participation
Affiliated to a French health insurance system (registered or beneficiary)

You will not qualify if you...

Alveolar hemorrhage requiring ventilation support at inclusion
Eosinophilic granulomatosis with polyangiitis (EGPA)
Active cancer (except non-melanoma skin cancer) within past 24 months
Active severe bacterial, viral, or fungal infection
History of bladder or urinary tract cancer
History of severe heart failure (Class 3/4) at any time
Recent heart failure symptoms (Class 2) within 3 months or ejection fraction <40%
Elevated liver transaminases (>2x normal) or severe chronic liver disease
Positive serology for HIV, HBV, or active HCV infection
Neutropenia <1000 cells/l within 1 month
Intolerance to thiazolidinediones, rituximab, or excipients
History of diabetic ketoacidosis
Risk or presence of macular edema
Pregnant, breastfeeding, or planning pregnancy within 24 months
Severe neurologic or psychiatric disease
Kidney transplant recipients
Recent cyclophosphamide or rituximab use above specified doses
High dose glucocorticoids within 4 weeks prior
Long-term high-dose oral glucocorticoids prior to screening
Current participation in therapeutic intervention research
Patients under guardianship or unable to follow study procedures
Recipients of State Medical Assistance (AME)

Research Team

Maxime Brussieux

Laura Le Mao

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