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
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

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
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
Contact Person Name
Anna Manonelles
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
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
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
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
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
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
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

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
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
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
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
Contact Person Name
José Silvano
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
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
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

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

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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