Actively Recruiting
A Multicenter Randomized Trial to Evaluate the Efficacy of Pioglitazone to Promote Renal Tolerance in ANCA-associated Vasculitis - RENATO
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-05-16
126
Participants Needed
24
Research Sites
26 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
Researchers are evaluating the use of pioglitazone to improve kidney outcomes in patients with ANCA-associated vasculitis who have confirmed kidney involvement. This phase 3 multicenter randomized controlled trial aims to see if adding pioglitazone to standard immunosuppressive therapy can reduce kidney damage. The study also looks at whether pioglitazone affects blood pressure, metabolic side effects of steroids, disease activity, and its safety in this patient group. Participants will be randomly assigned to receive either pioglitazone 30 mg daily or a placebo for 26 weeks, along with standard care. Standard treatment includes rituximab infusions given weekly for four weeks, then every six months, plus a steroid tapering schedule starting with intravenous pulses followed by oral prednisone. The study includes a follow-up period lasting 52 weeks with scheduled visits at weeks 1, 2, 3, 4, 8, 12, 26, 38, and 52. Biological samples such as plasma, serum, and urine will be collected at several visits for analysis. Participants will have regular assessments including kidney function and protein levels in the urine, disease activity scores, quality of life questionnaires, and safety monitoring throughout the study. The main measurement is improvement in serum creatinine and urine protein by week 26. Safety and side effects, especially related to glucocorticoid use, will be followed until week 52. The full study duration for each participant is about one year from treatment start to final follow-up.
CONDITIONS
Brief 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 (GPA or MPA) with active disease (BVAS ≥3)
- Proteinuria greater than 300 mg/g and haematuria over 10 RBC/hpf
- Estimated glomerular filtration rate (eGFR) of 15 mL/min/1.73 m2 or higher
- Recent renal biopsy (within 4 weeks) confirming active kidney involvement
- Aged 18 to 80 years
- Written informed consent given before participation
- Registered with or beneficiary of the French health insurance system
You will not qualify if you...
- Alveolar hemorrhage needing ventilation support at inclusion
- Eosinophilic granulomatosis with polyangiitis (EGPA)
- Active cancer (except non-melanoma skin cancer) within past 24 months
- Severe active infections (bacterial, viral, or fungal)
- History of bladder or urinary tract cancer
- Severe heart failure symptoms (Class 3/4) at any time
- Recent Class 2 heart failure symptoms or ejection fraction below 40% on recent echocardiography
- Liver enzymes more than twice normal or severe chronic liver disease
- Positive HIV, HBV, or active HCV infection at inclusion
- Neutropenia below 1000 cells/l in the past month
- Intolerance to thiazolidinediones, rituximab, or treatment components
- History of diabetic ketoacidosis
- Risk or presence of macular edema confirmed by eye exam
- Pregnant, breastfeeding, or planning pregnancy within 24 months without effective contraception
- Severe neurological or psychiatric disease
- Kidney transplant recipients
- Recent high-dose cyclophosphamide or rituximab use within 26 weeks prior
- High-dose intravenous glucocorticoids (>3000 mg methylprednisolone equivalent) within 4 weeks prior
- Prolonged oral glucocorticoid use >10 mg prednisone equivalent for over 6 weeks prior
- Current participation in another interventional research study
- Under guardianship or unable to follow study procedures
- Receiving State Medical Assistance (AME) program benefits
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 26 weeks
Participants are randomized to receive either pioglitazone or placebo daily for 26 weeks alongside standard immunosuppressive therapy for vasculitis flare.
Visits at Weeks 1, 2, 3, 4, 8, 12, and 26 during treatment
Duration - 26 weeks
Participants continue to be monitored for safety and efficacy outcomes after treatment ends.
Visits at Weeks 38 and 52
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
L
Laura Le Mao
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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