Informations générales (source: ClinicalTrials.gov)
A Multicenter Randomized Trial to Evaluate the Efficacy of Pioglitazone to Promote Renal Tolerance in ANCA-associated Vasculitis - RENATO
Interventional
Phase 3
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
octobre 2023
octobre 2027
03 septembre 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP Assistance publique - Hôpitaux de Paris | 13/12/2025 07:34:27 | Contacter | |||
| AP-HP - Hôpital Bicêtre | |||||
| AP-HP - Hôpital Bichat | |||||
| AP-HP - Hôpital Cochin | |||||
| AP-HP - Hôpital Europeen Georges Pompidou | |||||
| AP-HP - Hôpital Henri Mondor-Albert Chenevier | |||||
| AP-HP - Hôpital Necker-Enfants Malades | |||||
| AP-HP - Hôpital Tenon | |||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HM - Hôpital la Conception - 13005 - Marseille - France | Noémie Jourde-Chiche | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Départemental Vendée - 85925 - La Roche-sur-Yon - France | Grégoire COUVRAT-DESVERGNES | Contact (sur clinicalTrials) | |||
| CH de Boulogne sur Mer - 62200 - Boulogne-sur-Mer - France | Rafik Mesbah | Contact (sur clinicalTrials) | |||
| CH Valenciennes - 59300 - Valenciennes - France | Thomas Quemeneur | Contact (sur clinicalTrials) | |||
| Chru de Nancy - 54500 - Vandœuvre-lès-Nancy - France | Adrien Flahault | Contact (sur clinicalTrials) | |||
| CHU Amiens - 80000 - Amiens - France | Dimitri TITECA-BEAUPORT | Contact (sur clinicalTrials) | |||
| CHU Brest - Hôpital de la Cavale Blanche - 29200 - Brest - France | Emilie Cornec-Legall | Contact (sur clinicalTrials) | |||
| CHU d'Angers - 49933 - Angers - France | Jean-François AUGUSTO | Contact (sur clinicalTrials) | |||
| CHU de Dijon - 21000 - Dijon - France | Maxime Samson | Contact (sur clinicalTrials) | |||
| CHU de Grenoble - Hôpital Michalon site nord - 38043 - Grenoble - France | Pierre-Louis Carron | Contact (sur clinicalTrials) | |||
| CHU de Nantes - Hotel Dieu - 44093 - Nantes - France | Antoine Neel | Contact (sur clinicalTrials) | |||
| CHU de Rouen - 76000 - Rouen - France | Tristan De Nattes | Contact (sur clinicalTrials) | |||
| CHU de Strasbourg - 67000 - Strasbourg - France | Anna DUVAL | Contact (sur clinicalTrials) | |||
| CHU de Toulouse - Hôpital Rangueil - 31059 - Toulouse - France | Stanislas Faguer | Contact (sur clinicalTrials) | |||
| CHU Nîmes - Hôpital universitaire Caremeau - 30009 - Nîmes - France | Olivier Moranne | Contact (sur clinicalTrials) | |||
| CHU Pasteur 2 - Nice - 06000 - Nice - France | Clément GOSSET | Contact (sur clinicalTrials) | |||
| HEGP - 75015 - Paris - France | Alexandre Karras | Contact (sur clinicalTrials) | |||
| Hôpital Robert Schuman (UNEOS) - 57070 - Vantoux - France | Julien Campagne | Contact (sur clinicalTrials) | |||
Critères
Tous
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)
- 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)
- 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)