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Evaluating Pioglitazone for Kidney Health in ANCA-associated Vasculitis

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

Phase 3 Interventional Assistance Publique - Hôpitaux de Paris · NCT05946564

This study is testing if adding pioglitazone to standard treatment can help improve kidney health in people with ANCA-associated vasculitis.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment126 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorAssistance Publique - Hôpitaux de Paris Academic / other
Drugs / interventionsrituximab, methotrexate, Cyclophosphamide, prednisone
Locations24 sites (Amiens and 23 other locations)
Trial IDNCT05946564 on ClinicalTrials.gov

What this trial studies

The RENATO trial is a multicenter randomized controlled trial designed to assess the efficacy of pioglitazone in improving renal outcomes for patients diagnosed with ANCA-associated vasculitis. Participants will receive standard immunosuppressive therapy alongside either pioglitazone or a placebo for a duration of six months. The primary goal is to determine if pioglitazone can reduce kidney damage, as indicated by improvements in proteinuria and serum creatinine levels. Secondary objectives include evaluating its effects on hypertension, glucocorticoid metabolism, vasculitis activity, and safety profile.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 80 with newly-diagnosed or relapsing ANCA-associated vasculitis and active kidney involvement.

Not a fit: Patients with conditions such as alveolar hemorrhage requiring ventilation support or eosinophilic granulomatosis with polyangiitis may not benefit from this study.

Why it matters

Potential benefit: If successful, this trial could lead to improved kidney health and outcomes for patients suffering from ANCA-associated vasculitis.

How similar studies have performed: While this approach is novel in the context of ANCA-associated vasculitis, similar studies evaluating pioglitazone for other conditions have shown promising results.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Newly-diagnosed or relapsing ANCA-associated vasculitis, i.e. granulomatosis with polyangitis (GPA) or microscopic polyangiitis (MPA), according to ACR 1990 criteria and/or revised Chapel Hill Consensus Conference definitions and/or European Medical Agency algorithm, with an active disease defined as a BVAS ≥3
* Presence of proteinuria (UPCR \>300 mg/g), haematuria (\>10 RBC/hpf), and eGFR ≥15 mL/min/1.73 m2 (CKD-EPI formula) at inclusion (\<1 month)
* Recent (\<4 weeks) renal biopsy that confirms active renal involvement of ANCA-associated vasculitis
* Patients aged of 18 to 80 years
* Participant written informed consent prior to participation in the study
* Participants affiliated to a French health insurance system (registered or being a beneficiary of such a scheme)

Exclusion Criteria:

* Alveolar haemorrhage requiring pulmonary ventilation support at inclusion
* Patients with eosinophilic granulomatosis with polyangiitis (EGPA, Churg-Strauss)
* Active cancer (except non-melanoma skin cancer) within the past 24 months
* Active severe bacterial, viral or fungal infectious disease
* Past history of bladder or urinary tract cancer
* History of Class 3/4 congestive heart failure symptoms, any time
* History of Class 2 heart failure symptoms within the past 3 months and/or ejection fraction \<40% on recent echocardiography (\<1 month)
* Transaminases levels above 2 times the normal range value (\<1 month) or any severe chronic liver disease
* Positive serology for HIV, HBV (Ag HBs positivity) or active HCV infection at inclusion
* Presence of neutropenia \<1000 cells/l (\<1 month)
* History of intolerance to any thiazolidinedione (including Pioglitazone), to rituximab or any excipient listed in SmPc
* Diabetic ketoacidosis, any time
* A pre-existing or an important risk of new-onset macular edema (confirmed by an ophthalmological examination)
* Pregnant or breast-feeding women, or desire to become pregnant within 24 months All women of childbearing potential (WOCBP) are required to have a negative pregnancy test before treatment and must agree to maintain highly effective contraception by practicing abstinence or by using an effective method of birth control from the date of consent through the end of the study and another 12 months after (or 12 months after the last rituximab infusion in case of premature termination): Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (Oral, Intravaginal, Transdermal); Progestogen-only hormonal contraception associated with inhibition of ovulation (Oral, Injectable, Implantable); Intrauterine device (IUD); Intrauterine hormone-releasing system (IUS); Bilateral tubal occlusion; Vasectomised partner
* Severe neurologic or psychiatric disease (e.g., dementia or schizophrenia)
* Kidney transplant recipients
* Cyclophosphamide or rituximab (dose \> 375 mg/m2) use within 26 weeks prior to screening; if on azathioprine, mycophenolate mofetil or methotrexate at the time of screening, these drugs must be withdrawn prior to receiving the first rituximab dose. Patients that have initiated induction therapy with rituximab for the actual flare, can be included in the present study within 48h following the first rituximab infusion
* Intravenous glucocorticoids, \>3000 mg methylprednisolone equivalent, within 4 weeks prior to screening
* Patients who have been taking an oral daily dose of a glucocorticoid of more than 10 mg prednisone-equivalent for more than 6 weeks continuously prior to screening
* Current participation in another research study involving a therapeutic intervention. Participation to an observational research, or a non-interventional research is allowed
* Patients under guardianship or curators and protected adults
* Patients not able to understand and follow study procedures
* Patients on AME (Aide Médicale de l'Etat = State Medical Assistance)

Where this trial is running

Amiens and 23 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions ANCA Associated VasculitisRapidly Progressive GlomerulonephritisCrescentic GlomerulonephritisANCAvasculitis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.