Clinical trial • Not applicable • Immunology|Nephrology
RITUXIMAB for ANCA-associated vasculitis | End-stage renal disease
Not applicable trial of RITUXIMAB for ANCA-associated vasculitis | End-stage renal disease.
Overview
- Trial Therapeutic Area
- Immunology|Nephrology
- Trial Disease
- ANCA-associated vasculitis | End-stage renal disease
- Trial Stage
- Not applicable
- Drug Modality
- Monoclonal antibody|Small molecule
Key dates
- Initial CTIS Submission Date
- 06-03-2024
- First CTIS Authorization Date
- 09-04-2024
Trial design
Randomised, open-label, comparator (maintenance immunosuppressive therapy) includes: rituximab (injectable solution; maximum reported dose 500 mg), azathioprine (oral; up to 2 mg/kg), prednisone / prednisolone (oral; up to 20 mg), mycophenolate mofetil (oral; up to 2 g). (schedule/frequency not specified in the record.)-controlled Not applicable trial in France.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Comparator (maintenance immunosuppressive therapy) includes: RITUXIMAB (injectable solution; maximum reported dose 500 mg), AZATHIOPRINE (oral; up to 2 mg/kg), PREDNISONE / PREDNISOLONE (oral; up to 20 mg), MYCOPHENOLATE MOFETIL (oral; up to 2 g). (Schedule/frequency not specified in the record.)
- Target Sample Size
- 136
- Trial Duration For Participant
- 730
Eligibility
Recruits 136 No vulnerable population was selected. Patients under guardianship or trusteeship are excluded. Inability to understand and sign the informed consent is an exclusion criterion. Participation requires written informed consent from the patient (ICF_adults present); no assent procedures for minors are provided because only adults (≥18) are eligible..
- Pregnancy Exclusion
- Pregnant women; Women of child-bearing age without effective method of contraception
- Vulnerable Population
- No vulnerable population was selected. Patients under guardianship or trusteeship are excluded. Inability to understand and sign the informed consent is an exclusion criterion. Participation requires written informed consent from the patient (ICF_adults present); no assent procedures for minors are provided because only adults (≥18) are eligible.
Inclusion criteria
- {"criterion_text":"- Age ≥ 18 years and ≤ 90 years\n- Patients affected by a GPA or MPA AAV with a renal injury\n- Patients with initial manifestation or relapse of AAV\n- 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\n- Patients with ESRD on native kidney\n- Patients who gave written informed consent for participation in the study\n- Patients with affiliation to the French social security system"}
Exclusion criteria
- {"criterion_text":"- 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\n- Inability to understand and sign the informed consent\n- Pregnant women\n- Women of child-bearing age without effective method of contraception\n- Age < 18 years or > 90 years\n- Patients under guardianship or trusteeship\n- 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\n- Patients who received maintenance immunosuppressive treatment for more than 6 months during the last 12 months\n- Patient with a diagnosis of vasculitis other than GPA or MPA\n- Patients with another immunologic systemic disease (Lupus, sarcoidosis…)\n- Patients with active HCV, HBV or HIV infection\n- 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.)\n- Patients with uncontrolled cancer or hemopathy\n- Kidney transplant patient"}
Endpoints
Primary endpoints
- {"endpoint_text":"- 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.","definition_or_measurement_approach":"Severe prejudicial event defined as severe infection, major AAV relapse, or death during 24 months. Major relapses will be defined according to current European recommendations (EULAR). Severe infection is defined as an infection requiring hospital admission."}
Recruitment
- Planned Sample Size
- 136
- Recruitment Window Months
- 157
- Consent Approach
- Written informed consent is required from participants (ICF_adults and SIS_adults documents present). Only adults (≥18 years) are eligible; inability to understand or sign informed consent is an exclusion. Consent documents provided for adults; primary language indicated by translations and site country is French (French translation entries present). No assent for minors.
Geography
- Total Number Of Sites
- 53
- Total Number Of Participants
- 136
France
- Earliest CTIS Part Ii Submission Date
- 03-04-2024
- Latest Decision Or Authorization Date
- 22-01-2026
- Processing Time Days
- 659
- Number Of Sites
- 53
- Number Of Participants
- 136
Sites
- Site Name
- Hôpitaux Civils de Colmar
- Department Name
- Nephrology
- Principal Investigator Name
- Alexandre KLEIN
- Principal Investigator Email
- klein.alexandre@ch-colmar.fr
- Contact Person Name
- Alexandre KLEIN
- Contact Person Email
- klein.alexandre@ch-colmar.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Nephrology
- Principal Investigator Name
- Céline LEBAS
- Principal Investigator Email
- Celine.LEBAS@chru-lille.fr
- Contact Person Name
- Céline LEBAS
- Contact Person Email
- Celine.LEBAS@chru-lille.fr
- Site Name
- HÔPITAL EUROPÉEN GEORGE POMPIDOU
- Department Name
- Nephrology
- Principal Investigator Name
- Alexandre KARRAS
- Principal Investigator Email
- alexandre.karras@aphp.fr
- Contact Person Name
- Alexandre KARRAS
- Contact Person Email
- alexandre.karras@aphp.fr
- Site Name
- Centre Hospitalier Departemental Vendee
- Department Name
- Nephrology
- Principal Investigator Name
- Grégoire COUVRAT-DESVERGNES
- Principal Investigator Email
- gregoire.couvrat@ght85.fr
- Contact Person Name
- Grégoire COUVRAT-DESVERGNES
- Contact Person Email
- gregoire.couvrat@ght85.fr
- Site Name
- Hopital privée La Louvière
- Department Name
- Nephrology
- Principal Investigator Name
- Laurence VRIGNEAUD
- Principal Investigator Email
- l.vrigneaud@gmail.com
- Contact Person Name
- Laurence VRIGNEAUD
- Contact Person Email
- l.vrigneaud@gmail.com
- Site Name
- Centre Hospitalier Universitaire De Rennes
- Department Name
- Nephrology
- Principal Investigator Name
- Elsa VABRET
- Principal Investigator Email
- elsa.vabret@chu-rennes.fr
- Contact Person Name
- Elsa VABRET
- Contact Person Email
- elsa.vabret@chu-rennes.fr
- Site Name
- Centre Hospitalier Universitaire De Dijon
- Department Name
- Nephrology
- Principal Investigator Name
- Mathieu LEGENDRE
- Principal Investigator Email
- mathieu.legendre@chu-dijon.fr
- Contact Person Name
- Mathieu LEGENDRE
- Contact Person Email
- mathieu.legendre@chu-dijon.fr
- Site Name
- Besancon University Hospital Center
- Department Name
- Nephrology
- Principal Investigator Name
- Didier DUCLOUX
- Principal Investigator Email
- dducloux@chu-besancon.fr
- Contact Person Name
- Didier DUCLOUX
- Contact Person Email
- dducloux@chu-besancon.fr
- Site Name
- Hôpital Bichat Claude-Bernard AP-HP
- Department Name
- Nephrology
- Principal Investigator Name
- Eric DAUGAS
- Principal Investigator Email
- eric.daugas@aphp.fr
- Contact Person Name
- Eric DAUGAS
- Contact Person Email
- eric.daugas@aphp.fr
- Site Name
- Aub Sante
- Department Name
- Nephrology
- Principal Investigator Name
- Bruno LEGENDRE
- Principal Investigator Email
- bruno.legendre@aub-sante.fr
- Contact Person Name
- Bruno LEGENDRE
- Contact Person Email
- bruno.legendre@aub-sante.fr
- Site Name
- Centre Hospitalier Universitaire D'Angers
- Department Name
- Nephrology
- Principal Investigator Name
- Jean François AUGUSTO
- Principal Investigator Email
- JFAugusto@chu-angers.fr
- Contact Person Name
- Jean François AUGUSTO
- Contact Person Email
- JFAugusto@chu-angers.fr
- Site Name
- AUB SANTE
- Department Name
- Nephrology
- Principal Investigator Name
- Eric LARUELLE
- Principal Investigator Email
- eric.laruelle@aub-sante.fr
- Contact Person Name
- Eric LARUELLE
- Contact Person Email
- eric.laruelle@aub-sante.fr
- Site Name
- Centre Hospitalier Universitaire De Saint Etienne
- Department Name
- Nephrology
- Principal Investigator Name
- Christophe MARIAT
- Principal Investigator Email
- christophe.mariat@univ-st-etienne.fr
- Contact Person Name
- Christophe MARIAT
- Contact Person Email
- christophe.mariat@univ-st-etienne.fr
- Site Name
- Centre Hospitalier Eure-Seine
- Department Name
- Nephrology
- Principal Investigator Name
- Ancuta BOUFFANDEAU
- Principal Investigator Email
- ancuta.bouffandeau@chi-eureseine.fr
- Contact Person Name
- Ancuta BOUFFANDEAU
- Contact Person Email
- ancuta.bouffandeau@chi-eureseine.fr
- Site Name
- Hopital Saint Louis
- Department Name
- Nephrology
- Principal Investigator Name
- Evangéline PILLEBOUT
- Principal Investigator Email
- evangeline.pillebout@aphp.fr
- Contact Person Name
- Evangéline PILLEBOUT
- Contact Person Email
- evangeline.pillebout@aphp.fr
- Site Name
- Centre Hospitalier Le Mans
- Department Name
- Neph
- Principal Investigator Name
- Jean Philippe COINDRE
- Principal Investigator Email
- jpcoindre@ch-lemans.fr
- Contact Person Name
- Jean Philippe COINDRE
- Contact Person Email
- jpcoindre@ch-lemans.fr
- Site Name
- Centre Hospitalier Intercommunal De Cornouaille
- Department Name
- Nephrology
- Principal Investigator Name
- Pascale SIOHAN
- Principal Investigator Email
- p.siohan@ch-cornouaille.fr
- Contact Person Name
- Pascale SIOHAN
- Contact Person Email
- p.siohan@ch-cornouaille.fr
- Site Name
- Centre Hospitalier Groupe Hospitalier De La Rochelle Re Aunis
- Department Name
- Nephrology
- Principal Investigator Name
- François POURREAU
- Principal Investigator Email
- francois.pourreau@ch-larochelle.fr
- Contact Person Name
- François POURREAU
- Contact Person Email
- francois.pourreau@ch-larochelle.fr
- Site Name
- AUB Avranches
- Department Name
- Nephrology
- Principal Investigator Name
- Bruno LEGENDRE
- Principal Investigator Email
- bruno.legendre@aub-sante.fr
- Contact Person Name
- Bruno LEGENDRE
- Contact Person Email
- bruno.legendre@aub-sante.fr
- Site Name
- Centre Hospitalier Angouleme
- Department Name
- Nephrology
- Principal Investigator Name
- Dominique BLANCHIER
- Principal Investigator Email
- dominique.blanchier@ch-angouleme.fr
- Contact Person Name
- Dominique BLANCHIER
- Contact Person Email
- dominique.blanchier@ch-angouleme.fr
- Site Name
- Centre Hospitalier Regional Universitaire De Tours
- Department Name
- Nephrology
- Principal Investigator Name
- Jean-Michel HALIMI
- Principal Investigator Email
- jmhalimi@univ-tours.fr
- Contact Person Name
- Jean-Michel HALIMI
- Contact Person Email
- jmhalimi@univ-tours.fr
- Site Name
- Centre Hospitalier D'Arras
- Department Name
- Nephrology
- Principal Investigator Name
- Abo Bakr ABD EL FATAH MOHAMED
- Principal Investigator Email
- Abo-Bakr.ABD-EL-FATAH-MOHAMED@gh-artoisternois.fr
- Contact Person Name
- Abo Bakr ABD EL FATAH MOHAMED
- Contact Person Email
- Abo-Bakr.ABD-EL-FATAH-MOHAMED@gh-artoisternois.fr
- Site Name
- Les Hopitaux De Chartres
- Department Name
- Nephrology
- Principal Investigator Name
- Mohamed Riadh TROUDI
- Principal Investigator Email
- mtroudi@ch-chartres.fr
- Contact Person Name
- Mohamed Riadh TROUDI
- Contact Person Email
- mtroudi@ch-chartres.fr
- Site Name
- Centre Hospitalier Universitaire De Nimes
- Department Name
- Nephrology
- Principal Investigator Name
- Olivier MORRANE
- Principal Investigator Email
- Olivier.MORANNE@chu-nimes.fr
- Contact Person Name
- Olivier MORRANE
- Contact Person Email
- Olivier.MORANNE@chu-nimes.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Nephrology
- Principal Investigator Name
- Clément DELTOMBE
- Principal Investigator Email
- clement.deltombe@chu-nantes.fr
- Contact Person Name
- Clément DELTOMBE
- Contact Person Email
- clement.deltombe@chu-nantes.fr
- Site Name
- CHU De Rouen
- Department Name
- Nephrology
- Principal Investigator Name
- Dominique GUERROT
- Principal Investigator Email
- dominique.guerrot@chu-rouen.fr
- Contact Person Name
- Dominique GUERROT
- Contact Person Email
- dominique.guerrot@chu-rouen.fr
- Site Name
- APHP Ambroise Paré
- Department Name
- Nephrology
- Principal Investigator Name
- Julien DANG
- Principal Investigator Email
- julien.dang@aphp.fr
- Contact Person Name
- Julien DANG
- Contact Person Email
- julien.dang@aphp.fr
- Site Name
- Centre Hospitalier Universitaire Grenoble Alpes
- Department Name
- Nephrology
- Principal Investigator Name
- Pierre-Louis CARRON
- Principal Investigator Email
- PLCarron@chu-grenoble.fr
- Contact Person Name
- Pierre-Louis CARRON
- Contact Person Email
- PLCarron@chu-grenoble.fr
- Site Name
- Hopital Tenon
- Department Name
- Nephrology
- Principal Investigator Name
- Jean-Jacques BOFFA
- Principal Investigator Email
- jean-jacques.boffa@aphp.fr
- Contact Person Name
- Jean-Jacques BOFFA
- Contact Person Email
- jean-jacques.boffa@aphp.fr
- Site Name
- Centre Hospitalier Lyon Sud
- Department Name
- Nephrology
- Principal Investigator Name
- Laëtitia KOPPE
- Principal Investigator Email
- laetitia.koppe@chu-lyon.fr
- Contact Person Name
- Laëtitia KOPPE
- Contact Person Email
- laetitia.koppe@chu-lyon.fr
- Site Name
- CH Emile Roux
- Department Name
- Nephrology
- Principal Investigator Name
- Marc BOUILLER
- Principal Investigator Email
- marc.bouiller@ch-lepuy.fr
- Contact Person Name
- Marc BOUILLER
- Contact Person Email
- marc.bouiller@ch-lepuy.fr
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- Nephrology
- Principal Investigator Name
- Guillaume JEANTET
- Principal Investigator Email
- g-jeantet@chu-montpellier.fr
- Contact Person Name
- Guillaume JEANTET
- Contact Person Email
- g-jeantet@chu-montpellier.fr
- Site Name
- Groupe Hospitalier De La Region De Mulhouse Et Sud Alsace
- Department Name
- Nephrology
- Principal Investigator Name
- François CHANTREL
- Principal Investigator Email
- CHANTRELF@ghrmsa.fr
- Contact Person Name
- François CHANTREL
- Contact Person Email
- CHANTRELF@ghrmsa.fr
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Nephrology
- Principal Investigator Name
- Dominique CHAUVEAU
- Principal Investigator Email
- chauveau.d@chu-toulouse.fr
- Contact Person Name
- Dominique CHAUVEAU
- Contact Person Email
- chauveau.d@chu-toulouse.fr
- Site Name
- Centre Hospitalier Regional Et Universitaire De Brest
- Department Name
- Nephrology
- Principal Investigator Name
- Catherine HANROTEL-SALIOU
- Principal Investigator Email
- catherine.hanrotel-saliou@chu-brest.fr
- Contact Person Name
- Catherine HANROTEL-SALIOU
- Contact Person Email
- catherine.hanrotel-saliou@chu-brest.fr
- Site Name
- Centre Hospitalier Universitaire Amiens Picardie
- Department Name
- Nephrology
- Principal Investigator Name
- Dimitri TITECA-BEAUPORT
- Principal Investigator Email
- Titeca.Dimitri@chu-amiens.fr
- Contact Person Name
- Dimitri TITECA-BEAUPORT
- Contact Person Email
- Titeca.Dimitri@chu-amiens.fr
- Site Name
- AUB SANTE LORIENT
- Department Name
- Nephrology
- Principal Investigator Name
- Gabrielle DUNEAU
- Principal Investigator Email
- gabrielle.duneau@aub-sante.fr
- Contact Person Name
- Gabrielle DUNEAU
- Contact Person Email
- gabrielle.duneau@aub-sante.fr
- Site Name
- Centre Hospitalier Et Universitaire De Limoges
- Department Name
- Nephrology
- Principal Investigator Name
- Marie ESSIG
- Principal Investigator Email
- marie.essig@unilim.fr
- Contact Person Name
- Marie ESSIG
- Contact Person Email
- marie.essig@unilim.fr
- Site Name
- Centre Hospitalier Groupe Hospitalier Rance Emeraude
- Department Name
- Nephrology
- Principal Investigator Name
- Eric RENAUDINEAU
- Principal Investigator Email
- e.renaudineau@ch-stmalo.fr
- Contact Person Name
- Eric RENAUDINEAU
- Contact Person Email
- e.renaudineau@ch-stmalo.fr
- Site Name
- Clinique Nephrologique Saint Exupery
- Department Name
- Nephrology
- Principal Investigator Name
- Antoine DELARCHE
- Principal Investigator Email
- antoine.delarche@clinique-saint-exupery.com
- Contact Person Name
- Antoine DELARCHE
- Contact Person Email
- antoine.delarche@clinique-saint-exupery.com
- Site Name
- Hopital NOVO
- Department Name
- Nephrology
- Principal Investigator Name
- Charlotte JOUZEL
- Principal Investigator Email
- charlotte.jouzel@ght-novo.fr
- Contact Person Name
- Charlotte JOUZEL
- Contact Person Email
- charlotte.jouzel@ght-novo.fr
- Site Name
- Centre Hospitalier Universitaire De Poitiers
- Department Name
- Nephrology
- Principal Investigator Name
- Frank BRIDOUX
- Principal Investigator Email
- f.bridoux@chu-poitiers.fr
- Contact Person Name
- Frank BRIDOUX
- Contact Person Email
- f.bridoux@chu-poitiers.fr
- Site Name
- Centre Hospitalier De Boulogne Sur Mer
- Department Name
- Nephrology
- Principal Investigator Name
- Rafik MESBAH
- Principal Investigator Email
- r.mesbah@ch-boulogne.fr
- Contact Person Name
- Rafik MESBAH
- Contact Person Email
- r.mesbah@ch-boulogne.fr
- Site Name
- Centre hospitalier de Saint-Nazaire
- Department Name
- Nephrology
- Principal Investigator Name
- Domnique BESNIER
- Principal Investigator Email
- d.besnier@ch-saintnazaire.fr
- Contact Person Name
- Domnique BESNIER
- Contact Person Email
- d.besnier@ch-saintnazaire.fr
- Site Name
- Les Hopitaux Universitaires De Strasbourg
- Department Name
- Nephrology
- Principal Investigator Name
- Eric PRINZ
- Principal Investigator Email
- eric.prinz@chru-strasbourg.fr
- Contact Person Name
- Eric PRINZ
- Contact Person Email
- eric.prinz@chru-strasbourg.fr
- Site Name
- Centre Hospitalier Bretagne Atlantique
- Department Name
- Nephrology
- Principal Investigator Name
- Hugoline BOULAY
- Principal Investigator Email
- hugoline.boulay@ch-bretagne-atlantique.fr
- Contact Person Name
- Hugoline BOULAY
- Contact Person Email
- hugoline.boulay@ch-bretagne-atlantique.fr
- Site Name
- Centre Hospitalier Intercommunal De Mont De Marsan Et Du Pays Des Sources
- Department Name
- Nephrology
- Principal Investigator Name
- Magail JASIEK
- Principal Investigator Email
- magali.jasiek@ch-mdm.fr
- Contact Person Name
- Magail JASIEK
- Contact Person Email
- magali.jasiek@ch-mdm.fr
- Site Name
- Centre Hospitalier D Avignon
- Department Name
- Nephrology
- Principal Investigator Name
- David VERHELST
- Principal Investigator Email
- dverhelst@ch-avignon.fr
- Contact Person Name
- David VERHELST
- Contact Person Email
- dverhelst@ch-avignon.fr
- Site Name
- Centre Hospitalier Alpes-Leman
- Department Name
- Nephrology
- Principal Investigator Name
- Martin JANNOT
- Principal Investigator Email
- jannotmartin@gmail.com
- Contact Person Name
- Martin JANNOT
- Contact Person Email
- jannotmartin@gmail.com
- Site Name
- Expansion des Centres d'Hemodialyse de l'Ouest
- Department Name
- Nephrology
- Principal Investigator Name
- Guillaume SERET
- Principal Investigator Email
- gseret@echo-sante.com
- Contact Person Name
- Guillaume SERET
- Contact Person Email
- gseret@echo-sante.com
- Site Name
- Centre Hospitalier Yves Le Foll
- Department Name
- Nephrology
- Principal Investigator Name
- Caroline FREGUIN
- Principal Investigator Email
- caroline.freguin@ch-stbrieuc.fr
- Contact Person Name
- Caroline FREGUIN
- Contact Person Email
- caroline.freguin@ch-stbrieuc.fr
- Site Name
- University Hospital Of Clermont-Ferrand
- Department Name
- Nephrology
- Principal Investigator Name
- Julien ANIORT
- Principal Investigator Email
- janiort@chu-clermontferrand.fr
- Contact Person Name
- Julien ANIORT
- Contact Person Email
- janiort@chu-clermontferrand.fr
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- Nephrology
- Principal Investigator Name
- Noémie JOURDE
- Principal Investigator Email
- noemie.jourde@ap-hm.fr
- Contact Person Name
- Noémie JOURDE
- Contact Person Email
- noemie.jourde@ap-hm.fr
- Site Name
- Bicetre Hospital
- Department Name
- Nephrology
- Principal Investigator Name
- Antoine DURRBACH
- Principal Investigator Email
- antoine.durrbach@bct.aphp.fr
- Contact Person Name
- Antoine DURRBACH
- Contact Person Email
- antoine.durrbach@bct.aphp.fr
- Site Name
- Centre Hospitalier De Valenciennes
- Department Name
- Nephrology
- Principal Investigator Name
- Claire CARTERY
- Principal Investigator Email
- cartery-c@ch-valenciennes.fr
- Contact Person Name
- Claire CARTERY
- Contact Person Email
- cartery-c@ch-valenciennes.fr
- Site Name
- Hopital Henri Mondor - 1 rue Gustave Eiffel
- Department Name
- Nephrology
- Principal Investigator Name
- Nizar JOHER
- Principal Investigator Email
- nizar.joher@aphp.fr
- Contact Person Name
- Nizar JOHER
- Contact Person Email
- nizar.joher@aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Nephrology
- Principal Investigator Name
- Christian COMBE
- Principal Investigator Email
- christian.combe@chu-bordeaux.fr
- Contact Person Name
- Christian COMBE
- Contact Person Email
- christian.combe@chu-bordeaux.fr
- Site Name
- Centre Hospitalier Universitaire De Nice
- Department Name
- Nephrology
- Principal Investigator Name
- Marine ANDREANI
- Principal Investigator Email
- andreani.m@chu-nice.fr
- Contact Person Name
- Marine ANDREANI
- Contact Person Email
- andreani.m@chu-nice.fr
Sponsor
Primary sponsor
- Full Name
- Centre Hospitalier Departemental Vendee
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- France
Investigational products
- Investigational Product Name
- RITUXIMAB
- Active Substance
- RITUXIMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INJECTABLE SOLUTION
- Route
- INJECTABLE SOLUTION
- Authorisation Status
- Authorised
- Maximum Dose
- 500 mg
- Investigational Product Name
- AZATHIOPRINE
- Active Substance
- AZATHIOPRINE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised
- Maximum Dose
- 2 mg/kg
- Investigational Product Name
- PREDNISONE (CORTANCYL 20 mg)
- Active Substance
- PREDNISONE / PREDNISOLONE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised
- Maximum Dose
- 20 mg
- Investigational Product Name
- MYCOPHENOLATE MOFETIL (Mycophenolate mofetil Tillomed 500 mg)
- Active Substance
- MYCOPHENOLATE MOFETIL
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised
- Maximum Dose
- 2 g
- Combination Treatment
- Yes
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