AzTrials
AzTrials

ANCA Associated VasculitisPhase 3RENATONCT05946564

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

A Phase 3 study testing Pioglitazone (ACTOS®) in people with ANCA Associated Vasculitis and Rapidly Progressive Glomerulonephritis, run by Assistance Publique - Hôpitaux de Paris at 25 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The RENATO trial is a multicenter randomized controlled trial that evaluates the efficacy of pioglitazone to improve renal outcomes in ANCA-associated vasculitis. Patients with biopsy-proven kidney involvement of ANCA vasculitis will be included in this trial at diagnosis. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Pioglitazone (ACTOS®)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
126 participants
Where
25 sitesFrance
Study dates
24 Oct 2023to Nov 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 23Show fewer
  • 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)

Trial locations and contacts

25 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Maxime Brussieux contact

01 44 84 17 89

maxime.brussieux@aphp.fr

Laura Le Mao contact

01 56 09 54 97

laura.le-mao@aphp.fr

25 sites in 1 country

France25 sites, 25 recruiting

  • CHU Amiens

    Amiens, 80000

    Dimitri TITECA-BEAUPORT, titeca.dimitri@chu-amiens.fr

    Recruiting

  • CHU d'Angers

    Angers, 49933

    Jean-François AUGUSTO, 02 41 35 39 34, JFaugusto@chu-angers.fr

    Recruiting

  • CH de Boulogne sur Mer

    Boulogne-sur-Mer, 62200

    Rafik Mesbah, r.mesbah@ch-boulogne.fr

    Recruiting

  • CHU Brest - Hôpital de la Cavale Blanche

    Brest, 29200

    Emilie Cornec-Legall, emilie.cornec-legall@chu-brest.fr

    Recruiting

  • CHU de Dijon

    Dijon, 21000

    Maxime Samson, maxime.samson@chu-dijon.fr

    Recruiting

  • CHU de Grenoble - Hôpital Michalon site nord

    Grenoble, 38043

    Pierre-Louis Carron, PLCarron@chu-grenoble.fr

    Recruiting

  • Centre Hospitalier Départemental Vendée

    La Roche-sur-Yon, 85925

    Grégoire COUVRAT-DESVERGNES, gregoire.couvrat@ght85.fr

    Recruiting

  • Hopital Le Kremlin Bicetre - Aphp

    Le Kremlin-Bicêtre, 94270

    Mohamad Zaidan, +33 1 45 21 26 70, mohamad.zaidan@aphp.fr

    Recruiting

  • AP-HM - Hôpital la Conception

    Marseille, 13005

    Noémie Jourde-Chiche, Noemie.JOURDE@ap-hm.fr

    Recruiting

  • CHU de Nantes - Hotel Dieu

    Nantes, 44093

    Antoine Neel, antoine.neel@chu-nantes.fr

    Recruiting

  • CHU Pasteur 2 - Nice

    Nice, 06000

    Clément GOSSET, 04 92 03 77 77, gosset.c@chu-nice.fr

    Recruiting

  • CHU Nîmes - Hôpital universitaire Caremeau

    Nîmes, 30009

    Olivier Moranne, olivier.moranne@chu-nimes.fr

    Recruiting

  • AP-HP - Hôpital Cochin

    Paris, 75015

    Benjamin Terrier, benjamin.terrier@aphp.fr

    Recruiting

  • AP-HP - Necker enfants malades

    Paris, 75015

    Aurélie Hummel, aurelie.hummel@aphp.fr

    Recruiting

  • HEGP

    Paris, 75015

    Alexandre Karras, alexandre.karras@aphp.fr

    Recruiting

  • AP-HP - Hôpital Bichat

    Paris, 75018

    Eric Daugas, eric.daugas@aphp.fr

    Recruiting

  • AP-HP - Tenon

    Paris, 75020

    Jean-Jacques Boffa, jean-jacques.boffa@aphp.fr

    Recruiting

  • AP-HP - Henri Mondor

    Paris, 94000

    Vincent Audard, vincent.audard@aphp.fr

    Recruiting

  • AP-HP - Hôpital Ambroise-Paré

    Paris

    Julien Dang, +33 1 49 09 57 11, julien.dang@aphp.fr

    Recruiting

  • CHU de Rouen

    Rouen, 76000

    Tristan De Nattes, Tristan.De-Nattes@chu-rouen.fr

    Recruiting

  • CHU de Strasbourg

    Strasbourg, 67000

    Anna DUVAL, 03 69 55 00 65, anna.duval@chru-strasbourg.fr

    Recruiting

  • CHU de Toulouse - Hôpital Rangueil

    Toulouse, 31059

    Stanislas Faguer, faguer.s@chu-toulouse.fr

    Recruiting

  • CH Valenciennes

    Valenciennes, 59300

    Cyrille Vandenbussche, +33 3 27 14 30 89, vandenbussche-c@ch-valenciennes.fr

    Recruiting

  • Chru de Nancy

    Vandœuvre-lès-Nancy, 54500

    Adrien Flahault, a.flahault@chru-nancy.fr

    Recruiting

  • Hôpital Robert Schuman (UNEOS)

    Vantoux, 57070

    Julien Campagne, julien.campagne@uneos.fr

    Not yet recruiting

Other trials in France

About this study

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

The RENATO trial is a multicenter randomized controlled trial that evaluates the efficacy of pioglitazone to improve renal outcomes in ANCA-associated vasculitis.

Patients with biopsy-proven kidney involvement of ANCA vasculitis will be included in this trial at diagnosis. All patients will receive a standard of care immunosuppressive (SOC) therapy combining corticosteroids and rituximab (375 mg/m2/week for 4 consecutive weals followed by 500 mg re-infusion every 6 months). They will be randomized 1:1 to receive either pioglitazone 30 mg/day or placebo for 6 months, on top of SOC. The primary objective of this trial is to demonstrate that pioglitazone reduces kidney damage, reflected by the early improvement of proteinuria and serum creatinine levels. The secondary objectives will be to assess the efficacy of this drug on the reduction of hypertension and metabolic effects of glucocorticoids, to measure its impact on vasculitis activity and to evaluate the safety profile of pioglitazone in this population.

Read the detailed description

After a patient has consented to participate to the study, the informed consent form will be signed by the patient and the investigator. The patient will be randomized to one of two groups (pioglitazone or placebo). The patient will take the experimental treatment for 26 weeks and his research follow-up will last 52 weeks (follow-up visit : W1, W2, W3, W4 (research visit), W8, W12, W26, W38 and W52).

All participants will receive SOC immunosuppressive treatment with rituximab at 375 mg/m2/week for 4 consecutive weeks, as induction therapy of vasculitis flare, followed by 500 mg re-infusion every 6 months/24 weeks as maintenance therapy, i.e. at week 26 and 52, as recommended. The two treatment groups will also receive a standardized glucocorticoid tapering schedule: one to three i.v. pulses of methylprednisolone (7.5 to 15 mg/kg each) according to physician decision, followed by a predefined oral prednisone tapering schedule as used in the reduced-dose arm of the PEXIVAS trial.

Samples (plasma, serum and urine) taken as part of the study will be stored in a biological sample collection (at D0, W1, W2, W3, W12, W26, W38 and W52 visits).

Being tested
Pioglitazone (ACTOS®), Placebo of Pioglitazone
Keywords
ANCA, vasculitis
Medical subject headings
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Vasculitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pioglitazone (ACTOS®)Drug

    Patient will be randomize in the intervention group receive treatment by pioglitazone (30 mg/day orally) for 26 weeks on top of a SOC immunosuppressive treatment.

  • Placebo of PioglitazoneDrug

    Patient will be randomize in the intervention group receive treatment by placebo of pioglitazone (30 mg/day orally) for 26 weeks on top of a SOC immunosuppressive treatment.

Study groups in NCT05946564
Study groupRoleWhat they receive
Pioglitazone (ACTOS®)ExperimentalPioglitazone given once a day, orally, at 30 mg dose, for 26 weeks
Receives: Drug: Pioglitazone (ACTOS®)
Placebo of pioglitazonePlacebo comparatorPlacebo of pioglitazone, given once a day, orally, for 26 weeks
Receives: Drug: Placebo of Pioglitazone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Appearance of a success defined as (1) Delta sCreat > 30% (between D0 and week 26) AND (2) urine protein-to-creatinine (uPCR) < 1g/mmol

    Measured: Week 26

Secondary outcomes (16)

  1. Change of renal function

    Delta sCreat (baseline sCreat - follow-up sCreat)

    Measured: Weeks 4, 12, 26 and 52

  2. Proteinuria ratio

    Spot urine protein-to-creatinine ratio (uPCR)

    Measured: Weeks 4, 12, 26 and 52

  3. Score VDI (Vasculitis Damage Index)

    Systemic chronic damage due to vasculitis and treatment of vasculitis Min : 0 Max : 62 the best score is 0

    Measured: Week 26 and 52

  4. Renal vasculitis activity

    measurement of urine biomarkers: MCP-1

    Measured: Weeks 4, 12, 26 and 52

  5. Renal vasculitis activity

    measurement of urine biomarkers: KIM-1

    Measured: Weeks 4, 12, 26 and 52

  6. Renal vasculitis activity

    measurement of urine biomarkers: Calprotectin

    Measured: Weeks 4, 12, 26 and 52

  7. Renal vasculitis activity

    measurement of urine biomarkers: CD163

    Measured: Weeks 4, 12, 26 and 52

  8. Systemic vasculitis activity : score BVAS

    BVAS (Birmingham Vasculitis Activity Score ), ANCA positivity Min : 0 Max : 63 The best score is 0

    Measured: Weeks 4, 12, 26 and 52

  9. Refractory vasculitis

    Percentage of patients with refractory vasculitis and early vasculitis relapses

    Measured: Weeks 12, 26 and 52

  10. Improvement in Quality of Life (SF-36)

    SF-36 : Short-form 36 Min : 0 Max : 100 A low score reflects a perception of poor health, loss of function, presence of pain. A high score reflects a perception of good health, an absence of functional deficit and pain.

    Measured: baseline, weeks 4, 12, 26 and 52

  11. Improvement in Quality of Life (EQ-5D)

    EQ-5D : Euroqol Min: 0 Max : 100 Higher scores mean a better

    Measured: baseline, weeks 4, 12, 26 and 52

  12. Safety profile of pioglitazone

    numbers of adverse events, numbers of patients with adverse events, numbers of serious adverse events

    Measured: Weeks 26 and 52

  13. Toxicity induced by glucocorticoids

    Glucocorticoid Toxicity Index (GTI) the best score is 0

    Measured: Weeks 12, 26 and 52

  14. Change metabolic effects of Glucocorticoids

    To assess the efficacy of pioglitazone on the reduction metabolic side effects of glucocorticoids by HbA1c

    Measured: Weeks 12, 26 and 52.

  15. Change metabolic effects of Glucocorticoids

    To assess the efficacy of pioglitazone on the reduction metabolic side effects of glucocorticoids by evaluation of lipid profile

    Measured: Weeks 12, 26 and 52.

  16. Change blood pressure

    To assess the efficacy of pioglitazone on the reduction of hypertension)

    Measured: Weeks 12 and 26.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2023
  2. Study start24 Oct 2023
  3. Primary completion24 Apr 2028 (estimated)
  4. Study completionNov 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Comparative, multicentre, prospective, randomized, placebo-controlled double-blind phase III trial, evaluating the efficacy of add-on pioglitazone therapy on top of a standard of care (SOC) immunosuppressive therapy, in patients with ANCA-associated vasculitis and biopsy-proven renal involvement. Patients eligible for the study will be assigned in a 1:1 randomized fashion to additional treatment by pioglitazone (30 mg/day orally) or to placebo for 26 weeks on top of a SOC immunosuppressive treatment.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
126 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05946564
Sponsor's protocol ID
APHP211045
Other IDs
2022-501057-36-00, PHRC-20-0707
Acronym
RENATO
Status last verified
Jun 2026
First submitted
6 Jun 2023
Last updated
1 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pioglitazone (ACTOS®) in people with ANCA Associated Vasculitis and Rapidly Progressive Glomerulonephritis, run by Assistance Publique - Hôpitaux de Paris at 25 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Maxime Brussieux (01 44 84 17 89, maxime.brussieux@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Appearance of a success defined as (1) Delta sCreat > 30% (between D0 and week 26) AND (2) urine protein-to-creatinine (uPCR) < 1g/mmol (time frame: Week 26). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05946564.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in