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RECRUITING
NCT05946564
PHASE3

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

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DRUG

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