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Tests treatment safety and results for ANCA Associated Vasculitis
Official title A Trial to Evaluate the Efficacy of Pioglitazone to Promote Renal Tolerance in ANCA-associated Vasculitis - RENATO Trial
ClinicalTrials.gov ID: NCT05946564
What this study is testing
What is Pioglitazone (ACTOS®)?
Pioglitazone (ACTOS®) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for anca associated vasculitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Time commitment: about 52 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Newly-diagnosed or relapsing ANCA-associated vasculitis, i.e. granulomatosis with polyangitis (GPA) or microscopic polyangiitis (MPA), according to...
- 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
You likely can't join if
- 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
See the full eligibility 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...
- 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...
- 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...
- 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-treatment 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)
The study team makes the final eligibility decision.
Where it's taking place
- Amiens, France
- Angers, France
- Boulogne-sur-Mer, France
- Brest, France
- Dijon, France
- Grenoble, France
- La Roche-sur-Yon, France
- Le Kremlin-Bicêtre, France
- Marseille, France
- Nantes, France
- Nice, France
- Nîmes, France
- Paris, France
- Rouen, France
- Strasbourg, France
- Toulouse, France
- Valenciennes, France
- Vandœuvre-lès-Nancy, France
- Vantoux, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 52 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amiens, France; Angers, France; Boulogne-sur-Mer, France; Brest, France; Dijon, France; Grenoble, France and 13 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.