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Could a diabetes drug shield kidneys from autoimmune attack?

NCT ID NCT05946564

Disease control Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time

Summary

This trial investigates whether pioglitazone, a drug used for diabetes, can help protect the kidneys in people with ANCA-associated vasculitis—a rare autoimmune disease that causes inflammation of blood vessels, often damaging the kidneys. Participants receive either pioglitazone or a placebo for 6 months, alongside standard immunosuppressive therapy. The goal is to see if pioglitazone reduces protein in the urine and improves kidney function, potentially limiting long-term damage.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
pioglitazone
What this could lead to
If it works, pioglitazone could become a standard add-on therapy to protect kidney function and reduce long-term damage in ANCA vasculitis patients.
What could go wrong
This is a Phase 3 trial with 126 participants, so results may not apply to all patients. Pioglitazone has known risks like fluid retention and potential heart effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 126 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2023

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

anti-neutrophil cytoplasmic antibody-associated vasculitis crescentic glomerulonephritis granulomatosis with polyangiitis microscopic polyangiitis rapidly progressive glomerulonephritis vasculitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ANCA associated vasculitis Crescentic glomerulonephritis Rapidly progressive glomerulonephritis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    25 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AP-HM - Hôpital la Conception

    RECRUITING

    Marseille, 13005, France

  • AP-HP - Henri Mondor

    RECRUITING

    Paris, 94000, France

  • AP-HP - Hôpital Ambroise-Paré

    RECRUITING

    Paris, France

  • AP-HP - Hôpital Bichat

    RECRUITING

    Paris, 75018, France

  • AP-HP - Hôpital Cochin

    RECRUITING

    Paris, 75015, France

  • AP-HP - Necker enfants malades

    RECRUITING

    Paris, 75015, France

  • AP-HP - Tenon

    RECRUITING

    Paris, 75020, France

  • CH Valenciennes

    RECRUITING

    Valenciennes, 59300, France

  • CH de Boulogne sur Mer

    RECRUITING

    Boulogne-sur-Mer, 62200, France

  • CHU Amiens

    RECRUITING

    Amiens, 80000, France

  • CHU Brest - Hôpital de la Cavale Blanche

    RECRUITING

    Brest, 29200, France

  • CHU Nîmes - Hôpital universitaire Caremeau

    RECRUITING

    Nîmes, 30009, France

  • CHU Pasteur 2 - Nice

    RECRUITING

    Nice, 06000, France

  • CHU d'Angers

    RECRUITING

    Angers, 49933, France

  • CHU de Dijon

    RECRUITING

    Dijon, 21000, France

  • CHU de Grenoble - Hôpital Michalon site nord

    RECRUITING

    Grenoble, 38043, France

  • CHU de Nantes - Hotel Dieu

    RECRUITING

    Nantes, 44093, France

  • CHU de Rouen

    RECRUITING

    Rouen, 76000, France

  • CHU de Strasbourg

    RECRUITING

    Strasbourg, 67000, France

  • CHU de Toulouse - Hôpital Rangueil

    RECRUITING

    Toulouse, 31059, France

  • Centre Hospitalier Départemental Vendée

    RECRUITING

    La Roche-sur-Yon, 85925, France

  • Chru de Nancy

    RECRUITING

    Vandœuvre-lès-Nancy, 54500, France

  • HEGP

    RECRUITING

    Paris, 75015, France

  • Hopital Le Kremlin Bicetre - Aphp

    RECRUITING

    Le Kremlin-Bicêtre, 94270, France

  • Hôpital Robert Schuman (UNEOS)

    NOT_YET_RECRUITING

    Vantoux, 57070, France

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