Overview
Sponsor-declared trial summary
Phase
Phase III and Phase IV (Integrated)
Status
Ongoing, recruitment ended
Participants planned
136
Countries
1
Sites
58
End-stage Renal disease
The study's main objective is to demonstrate the superiority of immunosuppression discontinuation in ESRD-AAV patients compared to standard maintenance immunosuppressive therapy in terms of severe prejudicial event-free survival at 24 months.
Key facts
- Sponsor
- Centre Hospitalier Departemental Vendee
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02]
- Trial duration
- 2 Feb 2018 → ongoing
- Decision date (initial)
- 2024-04-09
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-512470-10-00
- EudraCT number
- 2017-000390-37
- ClinicalTrials.gov
- NCT03323476
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
The study's main objective is to demonstrate the superiority of immunosuppression discontinuation in ESRD-AAV patients compared to standard maintenance immunosuppressive therapy in terms of severe prejudicial event-free survival at 24 months.
Conditions and MedDRA coding
End-stage Renal disease
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- Age ≥ 18 years and ≤ 90 years
- Patients affected by a GPA or MPA AAV with a renal injury
- Patients with initial manifestation or relapse of AAV
- Patients with ESRD, defined by a glomerular filtration rate estimated using the MDRD formula ≤15 mL/min or requirement for dialysis for more than 60 days
- Patients with ESRD on native kidney
- Patients who gave written informed consent for participation in the study
- Patients with affiliation to the French social security system
Exclusion criteria 14
- Patients who experienced severe extra-renal disease due to AAV (intra-alveolar haemorrhage with blood oxygen saturation ≤ 85% on room air or ventilated, or central nervous system disease) in the last 12 months prior to inclusion
- Patients with AAV-associated renal involvement (with active inflammatory lesions in kidney biopsy) diagnosed less than three months and receiving induction treatment with Cyclophosphamide or Rituximab or diagnosed less than 45 days for patients who have received only treatment based on steroid infusion without Cyclophosphamide or Rituximab
- Patients who received maintenance immunosuppressive treatment for more than 6 months during the last 12 months
- Patient with a diagnosis of vasculitis other than GPA or MPA
- Patients with another immunologic systemic disease (Lupus, sarcoidosis…)
- Patients with active HCV, HBV or HIV infection
- Patients with a history of serious viral infection (CMV, HHV8, etc.) in the 2 months prior to the inclusion, or severe uncontrolled chronic infection (tuberculosis, etc.)
- Patients with uncontrolled cancer or hemopathy
- Kidney transplant patient
- Inability to understand and sign the informed consent
- Pregnant women
- Women of child-bearing age without effective method of contraception
- Age < 18 years or > 90 years
- Patients under guardianship or trusteeship
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary end point will be the time between randomization and the first severe prejudicial event (severe infection, major AAV relapse, death) during 24 months of follow-up.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
PRD1184454 · Product
- Active substance
- Azathioprine
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 2 mg/kg milligram(s)/kilogram
- Max total dose
- 2 mg/kg milligram(s)/kilogram
- Max treatment duration
- 2 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AX01 — AZATHIOPRINE
- Marketing authorisation
- 7259
- MA holder
- ASPEN PHARMA TRADING LIMITED
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
CORTANCYL 20 mg, comprimé sécable
PRD9995017 · Product
- Active substance
- Prednisone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 20 mg milligram(s)
- Max treatment duration
- 3 Month(s)
- Authorisation status
- Authorised
- ATC code
- H02AB07 — PREDNISONE
- Marketing authorisation
- 34009 332 838 5 8
- MA holder
- CHEPLAPHARM ARZNEIMITTEL GMBH
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Mycophenolate mofetil Tillomed 500 mg film-coated tablets
PRD10262742 · Product
- Active substance
- Mycophenolate Mofetil
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 2 g gram(s)
- Max total dose
- 2 g gram(s)
- Max treatment duration
- 2 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AA06 — MYCOPHENOLIC ACID
- Marketing authorisation
- PL 11311/0551
- MA holder
- TILLOMED LABORATORIES LTD
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 4
SCP24437829 · ATC
- Active substance
- Rituximab
- Substance synonyms
- CT-P10, PF-05280586, ABP 798, BI 695500, JHL1101, HLX01
- Route of administration
- INJECTABLE SOLUTION
- Max daily dose
- 500 mg milligram(s)
- Max total dose
- 500 mg milligram(s)
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XC02 — RITUXIMAB
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP129075 · ATC
- Active substance
- Azathioprine
- Route of administration
- ORAL
- Max daily dose
- 2 mg/kg milligram(s)/kilogram
- Max total dose
- 2 mg/kg milligram(s)/kilogram
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX01 — AZATHIOPRINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP131338 · ATC
- Active substance
- Prednisolone
- Substance synonyms
- (8S,9S,10S,11S,13S,14S,17R)-11,17-DIHYDROXY-17-(2-HYDROXYACETYL)-10,13-DIMETHYL-7,8,9,11,12,14,15,16-OCTAHYDRO-6H-CYCLOPENTA[A]PHENANTHREN-3-ONE, GLPG0303, DELTA-HYDROCORTISONE, 1,2-DEHYDROHYDROCORTISONE, METACORTANDRALONE
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 20 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- H02AB07 — PREDNISONE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP139856 · ATC
- Active substance
- Mycophenolate Mofetil
- Route of administration
- ORAL
- Max daily dose
- 2 g gram(s)
- Max total dose
- 2 g gram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AA06 — MYCOPHENOLIC ACID
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Departemental Vendee
- Sponsor organisation
- Centre Hospitalier Departemental Vendee
- Address
- Boulevard Stephane Moreau
- City
- La Roche Sur Yon Cedex 9
- Postcode
- 85925
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Departemental Vendee
- Contact name
- Chloé MOREAU
Public contact point
- Organisation
- Centre Hospitalier Departemental Vendee
- Contact name
- Chloé MOREAU
Locations
1 EU/EEA country · 58 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 136 | 58 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier Universitaire De Toulouse
Nephrology, 1 Avenue Du Professeur Jean Poulhes, Tsa 50032, Toulouse Cedex 9
Centre Hospitalier Intercommunal De Mont De Marsan Et Du Pays Des Sources
Nephrology, Avenue Pierre De Coubertin, Bp 417, Mont-De-Marsan Cedex
Groupe Hospitalier Rance Emeraude
Nephrology, 1 Rue De La Marne, 35403, Saint-Malo Cedex
Centre Hospitalier Universitaire De Poitiers
Nephrology, 2 Rue De La Miletrie, 86000, Poitiers
Centre Hospitalier Groupe Hospitalier De La Rochelle Re Aunis
Nephrology, 1 Rue Du Docteur Schweitzer, 17000, La Rochelle
Centre Hospitalier Bretagne Atlantique
Nephrology, 20 Boulevard General Maurice Guillaudot, 56000, Vannes
Hôpital Bichat Claude-Bernard AP-HP
Nephrology, 46 Rue Henri Huchard, cedex Paris 18, Paris
Centre Hospitalier Eure-Seine
Nephrology, Rue Léon Schwartzenberg, 27015, EVREUX
Aub Sante
Nephrology, 1 Boulevard De La Boutiere, Cs 86846, Saint-Gregoire
Hôpital Européen George Pompidou
Nephrology, 20 rue Leblanc, 75015, PARIS
Hopital Saint Louis
Nephrology, 1 Avenue Claude Vellefaux, 75010, Paris
CH Emile Roux
Nephrology, 12, bd du Dr Chantemesse, puy en velay
Centre Hospitalier Lyon Sud
Nephrology, 165 Chemin Du Grand Revoyet, 69310, Pierre-Benite
Centre Hospitalier Alpes-Leman
Nephrology, 558 Route De Findrol, 74130, Contamine-Sur-Arve
Centre Hospitalier D'Arras
Nephrology, 57 Avenue Winston Churchill, Bp 6, Arras Cedex
Centre Hospitalier Universitaire De Nice
Nephrology, 30 Voie Romaine, 06000, Nice
Centre Hospitalier D Avignon
Nephrology, 305 Rue Raoul Follereau, 84000, Avignon
CHU De Rouen
Nephrology, 1 Rue De Germont, Bp 96031, Rouen Cedex
University Hospital Of Clermont-Ferrand
Nephrology, 58 Rue Montalembert, 63003, Clermont Ferrand Cedex 1
Hopital NOVO
Nephrology, 6 Avenue De L Ile De France, 95300, Pontoise
Hôpitaux Civils de Colmar
Nephrology, 39 Av. de la Liberté, 68000, COLMAR
Centre Hospitalier Universitaire De Bordeaux
Nephrology, Place Amelie Raba Leon, 33000, Bordeaux
Centre Hospitalier Departemental Vendee
Nephrology, Boulevard Stephane Moreau, 85925, La Roche Sur Yon Cedex 9
Centre Hospitalier Universitaire De Nimes
Nephrology, 4 Place Du Professeur Robert Debre, Bp 40026, Nimes Cedex 9
Centre Hospitalier Universitaire D'Angers
Nephrology, 4 Rue Larrey, 49100, Angers
Centre Hospitalier Universitaire De Rennes
Nephrology, 2 Rue Henri Le Guilloux, 35000, Rennes
APHP Ambroise Paré
Nephrology, 9 avenue Charles-de-Gaulle, 92100, Boulogne-Billancourt
Centre Hospitalier Angouleme
Nephrology, Chem. du Grand Girac, 16959, Angouleme
Besancon University Hospital Center
Nephrology, 3 Boulevard Alexander Fleming, Cs 81816, Besancon Cedex
Hopital privée La Louvière
Nephrology, 69 Rue de la Louvière, 59000, LILLE
Centre Hospitalier Yves Le Foll
Nephrology, 10 Rue Marcel Proust, 22000, Saint-Brieuc
Centre Hospitalier Regional Universitaire De Tours
Nephrology, 2 Boulevard Tonnelle, 37000, Tours
Hopital Tenon
Nephrology, 4 Rue De La Chine, 75970, Paris Cedex 20
Centre Hospitalier Regional De Marseille
Nephrology, 147 Boulevard Baille, 13005, Marseille
Les Hopitaux De Chartres
Nephrology, 4 Rue Claude Bernard, 28630, Le Coudray
Expansion des Centres d'Hemodialyse de l'Ouest
Nephrology, 28 Rue de la Solitude, 72016, LE MANS
Aub Sante Lorient
Nephrology, 12 rue Camille Desmoulins, 56100, LORIENT
Centre Hospitalier Universitaire De Montpellier
Nephrology, 191 Avenue Du Doyen Gaston Giraud, 34090, Montpellier
Centre Hospitalier De Boulogne Sur Mer
Nephrology, 12 Allee Jacques Monod, 62200, Boulogne-Sur-Mer
Centre Hospitalier Intercommunal De Cornouaille
Nephrology, 14 Avenue Yves Thepot, Bp 31757, Quimper Cedex
Centre Hospitalier Universitaire Amiens Picardie
Nephrology, 1 Place Victor Pauchet, 80080, Amiens
Groupe Hospitalier De La Region De Mulhouse Et Sud Alsace
Nephrology, 20 Avenue Du Docteur Rene Laennec, 68100, Mulhouse
Centre Hospitalier Universitaire De Saint Etienne
Nephrology, St Priest En Jarez, 25 Boulevard Pasteur, St Etienne Cedex 2
Hopital Henri Mondor - 1 rue Gustave Eiffel
Nephrology, Av du Mal de Lattre de Tassigny, 94000, Créteil
Centre hospitalier de Saint-Nazaire
Nephrology, 11 Boulevard GEORGES CHARPAK, 44600, SAINT NAZAIRE
Centre Hospitalier Universitaire De Lille
Nephrology, 2 Avenue Oscar Lambret, Cs 70001, Lille Cedex
Bicetre Hospital
Nephrology, 78 Rue Du General Leclerc, 94275, Le Kremlin Bicetre Cedex
Centre Hospitalier Le Mans
Neph, 194 Avenue Rubillard, 72037, Le Mans Cedex 9
Centre Hospitalier Universitaire Grenoble Alpes
Nephrology, Boulevard De La Chantourne, Cs 10217, Grenoble Cedex 9
Centre Hospitalier De Valenciennes
Nephrology, 114 Avenue Desandrouin, 59300, Valenciennes
Les Hopitaux Universitaires De Strasbourg
Nephrology, 1 Place De L Hopital, Cs 80426, Strasbourg Cedex
Centre Hospitalier Et Universitaire De Limoges
Nephrology, 2 Avenue Martin Luther King, 87000, Limoges
Centre Hospitalier Universitaire De Nantes
Nephrology, 5 Allee De L Ile Gloriette, Cs 69301, Nantes Cedex 1
AUB Avranches
Nephrology, 56 rue de la liberté, 50300, AVRANCHES
Aub Sante
Nephrology, Rue Henri le Guilloux, 35033, RENNES
Centre Hospitalier Regional Et Universitaire De Brest
Nephrology, Boulevard Tanguy Prigent, 29609, Brest Cedex 2
Clinique Nephrologique Saint Exupery
Nephrology, 29 Rue Emile Lecrivain, 31400, Toulouse
Centre Hospitalier Universitaire De Dijon
Nephrology, 14 Rue Paul Gaffarel, 21000, Dijon
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2018-02-02 | 2018-02-02 | 2026-03-13 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 18 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Addendum | 1.0 |
| Protocol (for publication) | Protocol_2024-512470-10-00 | 10.0 |
| Protocol (for publication) | Protocol_TC | 10.0 |
| Recruitment arrangements (for publication) | Document additionnel | 1 |
| Recruitment arrangements (for publication) | Recruitment arrangements | 2.0 |
| Subject information and informed consent form (for publication) | ICF_adults | 3.1 |
| Subject information and informed consent form (for publication) | SIS_adults | 4.1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Bactrim | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Bactrim | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_MABTHERA | 3.0 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_Cellcept | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_Cellcept | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_Cortancyl | 3.0 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_Cortancyl | 3.0 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_Imurel | 3.0 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_Imurel | 3.0 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_Mabthera | 3.0 |
| Synopsis of the protocol (for publication) | Protocol synopsis_TC_2024-512470-10-00 | 12 |
Application history
9 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-06 | France | Acceptable 2024-04-08
|
2024-04-09 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-04-26 | France | Acceptable 2024-07-01
|
2024-07-02 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-07-17 | |||
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-09-16 | France | Acceptable 2024-10-22
|
2024-11-12 |
| 5 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-12-12 | France | Acceptable 2025-01-23
|
2025-02-19 |
| 6 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-03-11 | France | Acceptable 2025-04-17
|
2025-05-14 |
| 7 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-10-07 | France | Acceptable 2025-11-19
|
2025-11-19 |
| 8 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-12-09 | France | Acceptable | 2026-01-22 |
| 9 | SUBSTANTIAL MODIFICATION | SM-9 | 2026-01-26 | France | Acceptable 2026-02-12
|
2026-02-12 |