Clinical trial • Phase III • Immunology|Nephrology
Ravulizumab for Delayed graft function after kidney transplantation
Phase III trial of Ravulizumab for Delayed graft function after kidney transplantation.
Overview
- Trial Therapeutic Area
- Immunology|Nephrology
- Trial Disease
- Delayed graft function after kidney transplantation
- Trial Stage
- Phase III
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 28-02-2025
- First CTIS Authorization Date
- 18-06-2025
Trial design
Randomised, anti c5 complement mab placebo (placebo arm); active arm: ultomiris (ravulizumab) 1,100 mg/11 ml concentrate for solution for infusion administered iv (dose/schedule not specified in the record)-controlled Phase III trial in Austria, Czechia, Germany and others.
- Randomised
- Yes
- Comparator
- Anti C5 Complement mAb Placebo (placebo arm); active arm: Ultomiris (ravulizumab) 1,100 mg/11 mL concentrate for solution for infusion administered IV (dose/schedule not specified in the record)
- Target Sample Size
- 263
- Trial Duration For Participant
- 90
Eligibility
Recruits 263 Vulnerable population selected. Participants are adults (≥ 18 years). Subject information sheets and informed consent forms are provided for adult participants; no information on assent or parental consent is provided in the record..
- Vulnerable Population
- Vulnerable population selected. Participants are adults (≥ 18 years). Subject information sheets and informed consent forms are provided for adult participants; no information on assent or parental consent is provided in the record.
Inclusion criteria
- {"criterion_text":"- ≥ 18 years of age at the time of signing the informed consent\n- Diagnosed with dialysis-dependent End-Stage Kidney Disease (ESKD)\n- A candidate for kidney transplant from: a) Donation after Circulatory Death (DCD) donor; b) High-risk Donation after Brain Death (DBD) donor"}
Exclusion criteria
- {"criterion_text":"- Is to receive a kidney from a donor with category I,II,IV and V of the Maastricht Classification\n- Diagnosed with Acute Kidney Injury (AKI) of Stage 3 severity according to the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Time to freedom from dialysis through 90 days post-transplant","definition_or_measurement_approach":"Time to freedom from dialysis through 90 days post-transplant (measured as time to absence of dialysis up to day 90 post-transplant)."}
Secondary endpoints
- {"endpoint_text":"- DGF incidence: Requirement of at least 1 dialysis session within the first 7 days post-transplant","definition_or_measurement_approach":"Incidence defined as requirement of at least one dialysis session within the first 7 days post-transplant."}
- {"endpoint_text":"- Number of dialysis sessions through 90 days post-transplant","definition_or_measurement_approach":"Count of dialysis sessions through 90 days post-transplant."}
- {"endpoint_text":"- Time to first occurrence of eGFR ≥ 30 mL/min/1.73 m2 through 90 days post-transplant","definition_or_measurement_approach":"Time to first occurrence of estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m2 within 90 days post-transplant."}
Recruitment
- Digital Remote Recruitment
- True (website/newsletter postings, social media posts and digital flyers/newsletter content are included in country-specific recruitment materials)
- Planned Sample Size
- 263
- Recruitment Window Months
- 39
- Consent Approach
- Informed consent obtained from adult participants (≥18). Subject information sheets and informed consent forms (SIS and ICF) are provided for adult study participants and are available in multiple country/language versions (examples in German, Czech, English, Spanish, Italian, Portuguese, Polish, French). Optional consent forms are provided for genetic research and pregnancy follow-up where applicable.
Methods
- Recruitment brochures and patient study fact sheets (country-specific versions listed)
- Half-page advertisements (print) (country-specific versions listed)
- Website/newsletter postings (website/newsletter listing short and long) (country-specific versions listed)
- Social media posts (country-specific redacted examples included)
- PAG materials / Patient advocacy group (PAG) slides and PAG study introduction letters (materials referenced)
- Patient study introduction letters and patient appointment/visit guides
- Patient safety cards and other subject information material
Geography
- Total Number Of Sites
- 42
- Total Number Of Participants
- 170
Austria
- Earliest CTIS Part Ii Submission Date
- 29-04-2025
- Latest Decision Or Authorization Date
- 22-06-2025
- Processing Time Days
- 54
- Number Of Sites
- 2
- Number Of Participants
- 8
Sites
- Site Name
- Medical University Of Vienna
- Department Name
- Department of Internal Medicine III Division of Nephrology and Dialysis
- Principal Investigator Name
- Rainer Oberbauer
- Principal Investigator Email
- nephrologie@meduniwien.ac.at
- Contact Person Name
- Rainer Oberbauer
- Contact Person Email
- nephrologie@meduniwien.ac.at
- Site Name
- Medizinische Universitaet Innsbruck
- Department Name
- Visceral, Transplantation and Thoracic Surgery
- Principal Investigator Name
- Stefan Schneeberger
- Principal Investigator Email
- chirurgie@i-med.ac.at
- Contact Person Name
- Stefan Schneeberger
- Contact Person Email
- chirurgie@i-med.ac.at
Czechia
- Earliest CTIS Part Ii Submission Date
- 16-05-2025
- Latest Decision Or Authorization Date
- 18-06-2025
- Processing Time Days
- 33
- Number Of Sites
- 3
- Number Of Participants
- 10
Sites
- Site Name
- Institute For Clinical And Experimental Medicine
- Department Name
- Transplantcentrum, Klinika nefrologie
- Principal Investigator Name
- Ondrej Viklicky
- Principal Investigator Email
- ikem@ikem.cz
- Contact Person Name
- Ondrej Viklicky
- Contact Person Email
- ikem@ikem.cz
- Site Name
- Fakultni Nemocnice Hradec Kralove
- Department Name
- Chirurgická klinika, Nefrologická klinika
- Principal Investigator Name
- Igor Gunka
- Principal Investigator Email
- fnhk@fnhk.cz
- Contact Person Name
- Igor Gunka
- Contact Person Email
- fnhk@fnhk.cz
- Site Name
- Fakultni Nemocnice Ostrava
- Department Name
- Interní a kardiologická klinika
- Principal Investigator Name
- Zdenek Lys
- Principal Investigator Email
- fno@fno.cz
- Contact Person Name
- Zdenek Lys
- Contact Person Email
- fno@fno.cz
Germany
- Earliest CTIS Part Ii Submission Date
- 05-05-2025
- Latest Decision Or Authorization Date
- 23-06-2025
- Processing Time Days
- 49
- Number Of Sites
- 5
- Number Of Participants
- 35
Sites
- Site Name
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
- Department Name
- Nephrology
- Principal Investigator Name
- Julia Weinmann-Menke
- Principal Investigator Email
- Julia.weinmann-menke@unimeidzin-mainz.de
- Contact Person Name
- Julia Weinmann-Menke
- Contact Person Email
- Julia.weinmann-menke@unimeidzin-mainz.de
- Site Name
- Universitaetsklinikum Erlangen AöR
- Department Name
- Medical Department IV
- Principal Investigator Name
- Mirian Opgenoorth
- Principal Investigator Email
- med4@uk-erlangen.de
- Contact Person Name
- Mirian Opgenoorth
- Contact Person Email
- med4@uk-erlangen.de
- Site Name
- Universitaet Muenster
- Department Name
- Clinic for General, Visceral and Transplant Surgery
- Principal Investigator Name
- Philipp Houben
- Principal Investigator Email
- Philipp.Houben@ukmuenster.de
- Contact Person Name
- Philipp Houben
- Contact Person Email
- Philipp.Houben@ukmuenster.de
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Nephrology
- Principal Investigator Name
- Klemens Budde
- Principal Investigator Email
- klemens.budde@charite.de
- Contact Person Name
- Klemens Budde
- Contact Person Email
- klemens.budde@charite.de
- Site Name
- Universitaetsklinikum Schleswig-Holstein AöR
- Department Name
- Nephrology and Transplantation
- Principal Investigator Name
- Martin Nitschke
- Principal Investigator Email
- Nephrologieambulanz-kiel@uksh.de
- Contact Person Name
- Martin Nitschke
- Contact Person Email
- Nephrologieambulanz-kiel@uksh.de
Poland
- Earliest CTIS Part Ii Submission Date
- 11-06-2025
- Latest Decision Or Authorization Date
- 24-06-2025
- Processing Time Days
- 13
- Number Of Sites
- 4
- Number Of Participants
- 11
Sites
- Site Name
- Uniwersytecki Szpital Kliniczny W Poznaniu
- Department Name
- Oddzial Chirurgii Ogólnej i Transplantacyjnej
- Principal Investigator Name
- Marek Karczewski
- Principal Investigator Email
- szpital@usk.poznan.pl
- Contact Person Name
- Marek Karczewski
- Contact Person Email
- szpital@usk.poznan.pl
- Site Name
- Uniwersyteckie Centrum Kliniczne (Gdansk)
- Department Name
- Klinika Nefrologii, Transplantologii i Chorób Wewnetrznych
- Principal Investigator Name
- Maria Alicja Dębska-Ślizień
- Principal Investigator Email
- nefrologia@uck.gda.pl
- Contact Person Name
- Maria Alicja Dębska-Ślizień
- Contact Person Email
- nefrologia@uck.gda.pl
- Site Name
- Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
- Department Name
- Klinika Transplantologii, Immunologii, Nefrologii i Chorób Wewnetrznych
- Principal Investigator Name
- Magdalena Durlik
- Principal Investigator Email
- kl.trans.img.nef.skdj@uckwum.pl
- Contact Person Name
- Magdalena Durlik
- Contact Person Email
- kl.trans.img.nef.skdj@uckwum.pl
- Site Name
- Szpital Uniwersytecki Nr 1 Im. Dr. A. Jurasza W Bydgoszczy
- Department Name
- Klinika Transplantologii i Chirurgii Ogólnej
- Principal Investigator Name
- Zbigniew Wlodarczyk
- Principal Investigator Email
- kiktransp@jurasza.pl
- Contact Person Name
- Zbigniew Wlodarczyk
- Contact Person Email
- kiktransp@jurasza.pl
Spain
- Earliest CTIS Part Ii Submission Date
- 23-05-2025
- Latest Decision Or Authorization Date
- 26-06-2025
- Processing Time Days
- 34
- Number Of Sites
- 15
- Number Of Participants
- 50
Sites
- Site Name
- Fundacio Puigvert
- Department Name
- Nephrology
- Principal Investigator Name
- Christian Córdoba
- Principal Investigator Email
- ofgrin@fundacio-puigvert.es
- Contact Person Name
- Christian Córdoba
- Contact Person Email
- ofgrin@fundacio-puigvert.es
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Nephrology
- Principal Investigator Name
- Andres Amado
- Principal Investigator Email
- e.clinicostxrenal@gmail.com
- Contact Person Name
- Andres Amado
- Contact Person Email
- e.clinicostxrenal@gmail.com
- Site Name
- Bellvitge University Hospital
- Department Name
- Nephrology
- Principal Investigator Name
- Anna Manonelles
- Principal Investigator Email
- secretariaserveinefrologiaihemodialisis@bellvitgehospital.cat
- Contact Person Name
- Anna Manonelles
- Contact Person Email
- secretariaserveinefrologiaihemodialisis@bellvitgehospital.cat
- Site Name
- Hospital Universitario De Badajoz
- Department Name
- Nephrology
- Principal Investigator Name
- Román Hernández
- Principal Investigator Email
- nefrologia.chub@salud-juntaex.es
- Contact Person Name
- Román Hernández
- Contact Person Email
- nefrologia.chub@salud-juntaex.es
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Nephrology
- Principal Investigator Name
- Jordi Espi
- Principal Investigator Email
- trasplanterenal_dslafe@gva.es
- Contact Person Name
- Jordi Espi
- Contact Person Email
- trasplanterenal_dslafe@gva.es
- Site Name
- Hospital Universitario De Cruces
- Department Name
- Nephrology
- Principal Investigator Name
- Sofía Zarraga
- Principal Investigator Email
- hospitalde.cruces@osakidetza.eus
- Contact Person Name
- Sofía Zarraga
- Contact Person Email
- hospitalde.cruces@osakidetza.eus
- Site Name
- Hospital Del Mar
- Department Name
- Nephrology
- Principal Investigator Name
- María José Pérez
- Principal Investigator Email
- info@researchmar.net
- Contact Person Name
- María José Pérez
- Contact Person Email
- info@researchmar.net
- Site Name
- Hospital Universitario Reina Sofia
- Department Name
- Nephrology
- Principal Investigator Name
- María Dolores Navarro
- Principal Investigator Email
- nefro.hrs.sspa@juntadeandalucia.es
- Contact Person Name
- María Dolores Navarro
- Contact Person Email
- nefro.hrs.sspa@juntadeandalucia.es
- Site Name
- Hospital Universitario Virgen De Las Nieves
- Department Name
- Nephrology
- Principal Investigator Name
- María José Torres
- Principal Investigator Email
- snefro.hvn.sspa@juntadeandalucia.es
- Contact Person Name
- María José Torres
- Contact Person Email
- snefro.hvn.sspa@juntadeandalucia.es
- Site Name
- Hospital Universitario Regional De Malaga
- Department Name
- Nephrology
- Principal Investigator Name
- Verónica López
- Principal Investigator Email
- veronicaa.lopez.sspa@juntadeandalucia.es
- Contact Person Name
- Verónica López
- Contact Person Email
- veronicaa.lopez.sspa@juntadeandalucia.es
- Site Name
- Hospital Universitario Puerta Del Mar
- Department Name
- Nephrology
- Principal Investigator Name
- Florentino Villanego
- Principal Investigator Email
- secrenefr.hpm.sspa@juntadeandalucia.es
- Contact Person Name
- Florentino Villanego
- Contact Person Email
- secrenefr.hpm.sspa@juntadeandalucia.es
- Site Name
- Hospital Universitario Dr Peset Aleixandre
- Department Name
- Nephrology
- Principal Investigator Name
- Asunción Sancho
- Principal Investigator Email
- ensayos.nefro.peset@gmail.com
- Contact Person Name
- Asunción Sancho
- Contact Person Email
- ensayos.nefro.peset@gmail.com
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Nephrology
- Principal Investigator Name
- Fritz Diekmann
- Principal Investigator Email
- direccio@recerca.clinic.cat
- Contact Person Name
- Fritz Diekmann
- Contact Person Email
- direccio@recerca.clinic.cat
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Nephrology
- Principal Investigator Name
- Francesc Moreso
- Principal Investigator Email
- assajos.nefrologia@vhir.org
- Contact Person Name
- Francesc Moreso
- Contact Person Email
- assajos.nefrologia@vhir.org
- Site Name
- Hospital Universitario Miguel Servet
- Department Name
- Nephrology
- Principal Investigator Name
- Alex Gutiérrez-Dalmau
- Principal Investigator Email
- nefrologia.hums@salud.aragon.es
- Contact Person Name
- Alex Gutiérrez-Dalmau
- Contact Person Email
- nefrologia.hums@salud.aragon.es
Italy
- Earliest CTIS Part Ii Submission Date
- 23-05-2025
- Latest Decision Or Authorization Date
- 19-06-2025
- Processing Time Days
- 27
- Number Of Sites
- 6
- Number Of Participants
- 34
Sites
- Site Name
- Azienda Ospedaliera di Padova
- Department Name
- UOC Chirurgia dei Trapianti Rene e Pancreas
- Principal Investigator Name
- Lucrezia Furian
- Principal Investigator Email
- trapianti.renepancreas@aopd.veneto.it
- Contact Person Name
- Lucrezia Furian
- Contact Person Email
- trapianti.renepancreas@aopd.veneto.it
- Site Name
- Azienda Ospedaliero Universitaria Parma
- Department Name
- UO Nefrologia
- Principal Investigator Name
- Umberto Maggiore
- Principal Investigator Email
- umberto.maggiore@unipr.it
- Contact Person Name
- Umberto Maggiore
- Contact Person Email
- umberto.maggiore@unipr.it
- Site Name
- ASST Grande Ospedale Metropolitano Niguarda
- Department Name
- Nephrology
- Principal Investigator Name
- Enrico E. Minetti
- Principal Investigator Email
- enrico.minetti@ospedaleniguarda.it
- Contact Person Name
- Enrico E. Minetti
- Contact Person Email
- enrico.minetti@ospedaleniguarda.it
- Site Name
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
- Department Name
- UO Nefrologia, Dialisi e Trapianto
- Principal Investigator Name
- Gaetano La Manna
- Principal Investigator Email
- gaetano.lamanna@unibo.it
- Contact Person Name
- Gaetano La Manna
- Contact Person Email
- gaetano.lamanna@unibo.it
- Site Name
- Azienda Ospedaliero-Universitaria Citta Della Salute E Della Scienza Di Torino
- Department Name
- SC Nefrologia, Dialisi e Trapianto
- Principal Investigator Name
- Luigi Biancone
- Principal Investigator Email
- dialisicto@cittadellasalute.to.it
- Contact Person Name
- Luigi Biancone
- Contact Person Email
- dialisicto@cittadellasalute.to.it
- Site Name
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
- Department Name
- UOC Chirurgia Generale Trapianti di Rene
- Principal Investigator Name
- Mariano Ferraresso
- Principal Investigator Email
- mariano.ferraresso@unimi.it
- Contact Person Name
- Mariano Ferraresso
- Contact Person Email
- mariano.ferraresso@unimi.it
Portugal
- Earliest CTIS Part Ii Submission Date
- 14-05-2025
- Latest Decision Or Authorization Date
- 23-09-2025
- Processing Time Days
- 132
- Number Of Sites
- 5
- Number Of Participants
- 16
Sites
- Site Name
- Unidade Local De Saude De Santo Antonio E.P.E.
- Department Name
- Serviço de Nefrologia
- Principal Investigator Name
- José Silvano
- Principal Investigator Email
- geral.investigacao.defi@chporto.min-saude.pt
- Contact Person Name
- José Silvano
- Contact Person Email
- geral.investigacao.defi@chporto.min-saude.pt
- Site Name
- Unidade Local De Saude De Santa Maria E.P.E.
- Department Name
- Serviço de Nefrologia e Transplantação Renal
- Principal Investigator Name
- Fernando Abreu
- Principal Investigator Email
- CIC@ulssm.min-saude.pt
- Contact Person Name
- Fernando Abreu
- Contact Person Email
- CIC@ulssm.min-saude.pt
- Site Name
- Unidade Local De Saude De Sao Jose E.P.E.
- Department Name
- Serviço de Nefrologia
- Principal Investigator Name
- Inês Aires
- Principal Investigator Email
- consulta.trenal.hcc@ulssjose.min-saude.pt
- Contact Person Name
- Inês Aires
- Contact Person Email
- consulta.trenal.hcc@ulssjose.min-saude.pt
- Site Name
- Unidade Local De Saude De Sao Joao E.P.E.
- Department Name
- Serviço de Nefrologia
- Principal Investigator Name
- Susana Norton
- Principal Investigator Email
- centro.investigacao@chsj.min-saude.pt
- Contact Person Name
- Susana Norton
- Contact Person Email
- centro.investigacao@chsj.min-saude.pt
- Site Name
- Unidade Local De Saude De Lisboa Ocidental E.P.E.
- Department Name
- Serviço de Nefrologia
- Principal Investigator Name
- Eunice Cacheira
- Principal Investigator Email
- ensaiosclinicos@chlo.min-saude.pt
- Contact Person Name
- Eunice Cacheira
- Contact Person Email
- ensaiosclinicos@chlo.min-saude.pt
France
- Earliest CTIS Part Ii Submission Date
- 10-02-2026
- Latest Decision Or Authorization Date
- 09-03-2026
- Processing Time Days
- 28
- Number Of Sites
- 2
- Number Of Participants
- 6
Sites
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Nephrology and Transplantation
- Principal Investigator Name
- Nassim Kamar
- Principal Investigator Email
- kamar.n@chu-toulouse.fr
- Contact Person Name
- Nassim Kamar
- Contact Person Email
- kamar.n@chu-toulouse.fr
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- Nephrology
- Principal Investigator Name
- Jean Emmanuel Serre
- Principal Investigator Email
- RechercheNephro@chu-montpellier.fr
- Contact Person Name
- Jean Emmanuel Serre
- Contact Person Email
- RechercheNephro@chu-montpellier.fr
Sponsor
Primary sponsor
- Full Name
- Alexion Pharmaceuticals Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- CTI Clinical Trial and Consulting Services Europe GmbH
- Responsibilities
- codes 1,12,13,2,5
- Name
- Cti Clinical Trial Services Inc.
- Responsibilities
- code 4
- Name
- CTI Laboratory Services Spain S.L.
- Responsibilities
- code 4
Third parties
- {"country":"Spain","full_name":"CTI Laboratory Services Spain S.L.","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Cytel Inc.","duties_or_roles":"Data Monitoring Committee","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Cti Clinical Trial Services Inc.","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"eCOA-electronical Clinical Outcome Assessments; code 7","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"codes 14; 15 (Provision of materials as required by local regulations)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Nephropathology Associates PLC","duties_or_roles":"code 15 (Kidney biopsy reading)","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Germany","full_name":"CTI Clinical Trial and Consulting Services Europe GmbH","duties_or_roles":"codes 1,12,13,2,5","organisation_type":"Pharmaceutical company"}
- {"country":"Belgium","full_name":"CluePoints","duties_or_roles":"code 15 (Risk-Based Study Execution (RBx) & Data Quality Oversight)","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Mde Healthcare Services Limited","duties_or_roles":"code 15 (Home Health care, Patient expenses reimbursement)","organisation_type":"Non-Pharmaceutical company"}
- {"country":"France","full_name":"Novasco","duties_or_roles":"code 15 (Patient reimbursements for French Patients)","organisation_type":"Pharmaceutical company"}
- {"country":"India","full_name":"Accenture Solutions Private Limited","duties_or_roles":"code 15 (Global Safety Case Processing)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"code 3","organisation_type":"Non-Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Ultomiris 1,100 mg/11 mL concentrate for solution for infusion
- Active Substance
- Ravulizumab
- Modality
- Monoclonal antibody
- Routes Of Administration
- IV infusion
- Route
- IV infusion
- Authorisation Status
- Authorised (EU marketing authorisation EU/1/19/1371/003)
- Maximum Dose
- 3600 mg
- Investigational Product Name
- Anti C5 Complement mAb Placebo
- Modality
- Other
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