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A Trial to Evaluate the Efficacy of Pioglitazone to Promote Renal Tolerance in ANCA-associated Vasculitis - RENATO Trial
Sponsor: Assistance Publique - Hôpitaux de Paris
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. 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.
Official title: A Multicenter Randomized Trial to Evaluate the Efficacy of Pioglitazone to Promote Renal Tolerance in ANCA-associated Vasculitis - RENATO
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
126
Start Date
2023-10-24
Completion Date
2027-10-24
Last Updated
2025-05-16
Healthy Volunteers
No
Conditions
Interventions
Pioglitazone (ACTOS®)
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 Pioglitazone
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.
Locations (24)
CHU Amiens
Amiens, France
CHU d'Angers
Angers, France
CH de Boulogne sur Mer
Boulogne-sur-Mer, France
CHU Brest - Hôpital de la Cavale Blanche
Brest, France
CHU de Dijon
Dijon, France
CHU de Grenoble - Hôpital Michalon site nord
Grenoble, France
Centre Hospitalier Départemental Vendée
La Roche-sur-Yon, France
Hopital Le Kremlin Bicetre - Aphp
Le Kremlin-Bicêtre, France
AP-HM - Hôpital la Conception
Marseille, France
CHU de Nantes - Hotel Dieu
Nantes, France
CHU Pasteur 2 - Nice
Nice, France
CHU Nîmes - Hôpital universitaire Caremeau
Nîmes, France
AP-HP - Hôpital Cochin
Paris, France
AP-HP - Necker enfants malades
Paris, France
HEGP
Paris, France
AP-HP - Hôpital Bichat
Paris, France
AP-HP - Tenon
Paris, France
AP-HP - Henri Mondor
Paris, France
CHU de Rouen
Rouen, France
CHU de Strasbourg
Strasbourg, France
CHU de Toulouse - Hôpital Rangueil
Toulouse, France
CH Valenciennes
Valenciennes, France
Chru de Nancy
Vandœuvre-lès-Nancy, France
Hôpital Robert Schuman (UNEOS)
Vantoux, France