Trials Sponsors Conditions Drugs Pricing

Conditions

ANCA Associated Vasculitis Rapidly Progressive Glomerulonephritis Crescentic Glomerulonephritis ANCA-associated vasculitis

Keywords

ANCAvasculitis

Outcome Measures

Primary Outcomes (1)

Appearance of a success defined as (1) Delta sCreat > 30% (between D0 and week 26) AND (2) urine protein-to-creatinine (uPCR) < 1g/mmol
Week 26

Secondary Outcomes (16)

Change of renal function
Weeks 4, 12, 26 and 52
Proteinuria ratio
Weeks 4, 12, 26 and 52
Score VDI (Vasculitis Damage Index)

Study Arms (2)

Pioglitazone (ACTOS®)

EXPERIMENTAL

Pioglitazone given once a day, orally, at 30 mg dose, for 26 weeks

Drug: Pioglitazone (ACTOS®)

Placebo of pioglitazone

PLACEBO COMPARATOR

Placebo of pioglitazone, given once a day, orally, for 26 weeks

Drug: Placebo of Pioglitazone

Interventions

Pioglitazone (ACTOS®)Drug

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.

Pioglitazone (ACTOS®)

Placebo of PioglitazoneDrug

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.

Placebo of pioglitazone

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Formulated product
PREDNISONE
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
TABLET
View registry record
Formulated product
DEXCHLORPHENIRAMINE
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
View registry record
Formulated product
PARACETAMOL
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
FILM-COATED TABLET
View registry record
Formulated product
Actos 30 mg tablets
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
TABLET
View registry record
Formulated product
METHYLPREDNISOLONE HEMISUCCINATE
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.

Ingredients named in source formulations

The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.

PREDNISONE
Named ingredient: Prednisone
View registry record
DEXCHLORPHENIRAMINE
Named ingredient: dexchlorpheniramine
View registry record
PARACETAMOL
Named ingredient: Paracetamol
View registry record
Actos 30 mg tablets
Named ingredient: Pioglitazone
View registry record
METHYLPREDNISOLONE HEMISUCCINATE
Named ingredient: Methylprednisolone Hemisuccinate
View registry record
METHYLPREDNISOLONE
Named ingredient: Methylprednisolone
View registry record
RITUXIMAB
Named ingredient: Rituximab
View registry record

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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 definitions and/or European Medical Agency algorithm, with an active disease defined as a BVAS ≥3

Sponsors & Collaborators

Ministry of Health, France
Governmentcollaborator
Assistance Publique - Hôpitaux de Paris
Otherlead
Assistance Publique Hopitaux De Paris

Study Sites (25)

CHU Amiens

Amiens, 80000, France

RECRUITING

Dimitri TITECA-BEAUPORTCONTACTtiteca.dimitri@chu-amiens.fr

CHU d'Angers

Angers, 49933, France

RECRUITING

Jean-François AUGUSTOCONTACT02 41 35 39 34 JFaugusto@chu-angers.fr

MeSH Terms

Conditions

Anti-Neutrophil Cytoplasmic Antibody-Associated VasculitisVasculitis

Interventions

Pioglitazone

Condition Hierarchy (Ancestors)

Systemic VasculitisVascular DiseasesCardiovascular DiseasesSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones

Study Officials

Alexandre Karras
Assistance Publique - Hôpitaux de Paris
PRINCIPAL INVESTIGATOR

Central Study Contacts

Maxime Brussieux

CONTACT

01 44 84 17 89 maxime.brussieux@aphp.fr

Laura Le Mao

CONTACT

01 56 09 54 97

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details: Double-blind (investigators and patients)
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 6, 2023

First Posted

July 14, 2023

Study Start

You may not qualify if:

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
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 highly effective contraception by practicing abstinence or by using an effective method of birth control from the date of consent through the end of the study and another 12 months after (or 12 months after the last rituximab infusion in case of premature termination): Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (Oral, Intravaginal, Transdermal); Progestogen-only hormonal contraception associated with inhibition of ovulation (Oral, Injectable, Implantable); Intrauterine device (IUD); Intrauterine hormone-releasing system (IUS); Bilateral tubal occlusion; Vasectomised partner
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 receiving the first rituximab dose. Patients that have initiated induction therapy with rituximab for the actual flare, can be included in the present study within 48h following the first rituximab infusion
+6 more criteria

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (16)

Study Arms (2)

Pioglitazone (ACTOS®)

Placebo of pioglitazone

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (25)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source records

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (16)

Study Arms (2)

Pioglitazone (ACTOS®)

Placebo of pioglitazone

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (25)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source records

Locations