Actively Recruiting
A Trial to Evaluate the Efficacy of Pioglitazone to Promote Renal Tolerance in ANCA-associated Vasculitis - RENATO Trial
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-05-16
126
Participants Needed
24
Research Sites
208 weeks
Total Duration
On this page
Sponsors
A
Assistance Publique - Hôpitaux de Paris
Lead Sponsor
M
Ministry of Health, France
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Trial to Evaluate the Efficacy of Pioglitazone to Promote Renal Tolerance in ANCA-associated Vasculitis - RENATO Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed or relapsing ANCA-associated vasculitis including granulomatosis with polyangiitis or microscopic polyangiitis with active disease (BVAS 63)
- Presence of proteinuria (UPCR >300 mg/g), hematuria (>10 RBC/hpf), and eGFR 615 mL/min/1.73 m2 at inclusion within 1 month
- Recent renal biopsy (less than 4 weeks) confirming active renal involvement of ANCA-associated vasculitis
- Age between 18 and 80 years
- Written informed consent prior to participation
- Affiliation with a French health insurance system (registered or beneficiary)
You will not qualify if you...
- Alveolar hemorrhage requiring pulmonary ventilation support at inclusion
- Diagnosis of eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome)
- Active cancer (except non-melanoma skin cancer) within the past 24 months
- Active severe bacterial, viral, or fungal infection
- Past history of bladder or urinary tract cancer
- History of severe congestive heart failure symptoms (Class 3/4) at any time
- History of moderate heart failure symptoms (Class 2) within past 3 months or ejection fraction <40% in recent echocardiography
- Elevated liver transaminases (more than 2 times normal) within 1 month or severe chronic liver disease
- Positive serology for HIV, hepatitis B (HBV), or active hepatitis C (HCV) infection at inclusion
- Neutropenia with neutrophil count less than 1000 cells/l within 1 month
- Intolerance to thiazolidinediones (including pioglitazone), rituximab, or any listed excipients
- History of diabetic ketoacidosis
- Pre-existing or high risk of new-onset macular edema confirmed by eye exam
- Pregnancy, breastfeeding, or desire to become pregnant within 24 months; women of childbearing potential must have negative pregnancy test and agree to effective contraception
- Severe neurological or psychiatric disease such as dementia or schizophrenia
- Kidney transplant recipients
- Use of cyclophosphamide or rituximab greater than 375 mg/m2 within 26 weeks prior to screening; withdrawal of certain immunosuppressants prior to rituximab required
- High-dose intravenous glucocorticoids (>3000 mg methylprednisolone equivalent) within 4 weeks prior to screening
- Continuous oral glucocorticoid use over 10 mg prednisone-equivalent for more than 6 weeks prior to screening
- Current participation in other therapeutic research studies; observational or non-interventional studies allowed
- Patients under guardianship, curatorship, or protected adults
- Inability to understand or follow study procedures
- Patients on State Medical Assistance (AME)
AI-Screening
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Trial Site Locations
Total: 24 locations
1
CHU Amiens
Amiens, France, 80000
Actively Recruiting
2
CHU d'Angers
Angers, France, 49933
Actively Recruiting
3
CH de Boulogne sur Mer
Boulogne-sur-Mer, France, 62200
Actively Recruiting
4
CHU Brest - Hôpital de la Cavale Blanche
Brest, France, 29200
Actively Recruiting
5
CHU de Dijon
Dijon, France, 21000
Actively Recruiting
6
CHU de Grenoble - Hôpital Michalon site nord
Grenoble, France, 38043
Actively Recruiting
7
Centre Hospitalier Départemental Vendée
La Roche-sur-Yon, France, 85925
Actively Recruiting
8
Hopital Le Kremlin Bicetre - Aphp
Le Kremlin-Bicêtre, France, 94270
Actively Recruiting
9
AP-HM - Hôpital la Conception
Marseille, France, 13005
Actively Recruiting
10
CHU de Nantes - Hotel Dieu
Nantes, France, 44093
Actively Recruiting
11
CHU Pasteur 2 - Nice
Nice, France, 06000
Actively Recruiting
12
CHU Nîmes - Hôpital universitaire Caremeau
Nîmes, France, 30009
Actively Recruiting
13
AP-HP - Hôpital Cochin
Paris, France, 75015
Actively Recruiting
14
AP-HP - Necker enfants malades
Paris, France, 75015
Actively Recruiting
15
HEGP
Paris, France, 75015
Actively Recruiting
16
AP-HP - Hôpital Bichat
Paris, France, 75018
Actively Recruiting
17
AP-HP - Tenon
Paris, France, 75020
Actively Recruiting
18
AP-HP - Henri Mondor
Paris, France, 94000
Actively Recruiting
19
CHU de Rouen
Rouen, France, 76000
Actively Recruiting
20
CHU de Strasbourg
Strasbourg, France, 67000
Actively Recruiting
21
CHU de Toulouse - Hôpital Rangueil
Toulouse, France, 31059
Actively Recruiting
22
CH Valenciennes
Valenciennes, France, 59300
Actively Recruiting
23
Chru de Nancy
Vandœuvre-lès-Nancy, France, 54500
Actively Recruiting
24
Hôpital Robert Schuman (UNEOS)
Vantoux, France, 57070
Not Yet Recruiting
Research Team
M
Maxime Brussieux
CONTACT
L
Laura Le Mao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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