Real-World Effectiveness and Safety of Pegcetacoplan in Patients With C3G or IC-MPG: A Multi-Country Study
2 other identifiers
interventional
150
13 countries
97
Brief Summary
The purpose of this study is to evaluate the effectiveness and safety of Pegcetacoplan in patients with C3G and primary IC-MPGN in the real-world setting. This study will also assess biomarkers not routinely measured in clinical practice. Results will support the long-term evaluation of the benefit-risk profile of pegcetacoplan in a broad patient population, informing clinical decision-making.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jul 2026
Longer than P75 for phase_4
97 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 26, 2026
CompletedStudy Start
First participant enrolled
July 9, 2026
CompletedFirst Posted
Study publicly available on registry
August 5, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 31, 2032
August 5, 2026
January 1, 2026
5.5 years
March 26, 2026
July 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Achieving urine protein-to-creatinine ratio (UPCR) of <1 g/g
To describe the real-world clinical effectiveness of pegcetacoplan in participants with C3G or primary IC-MPGN
at 6 months after starting pegcetacoplan treatment
Secondary Outcomes (33)
Participant demographics (age, sex, race)
Day 1 of treatment/Baseline.
Clinical characteristics of renal disease (UPCR)
Prior to and - Day 1 of treatment/Baseline.
Clinical characteristics of renal disease (eGFR)
Prior to and - Day 1 of treatment/Baseline.
Prior and concomitant C3G and primary IC-MPGN treatment information
Day 1 of treatment/Baseline.
≥50% proteinuria reduction
At 1, 3, 6, 12 months and then every 6 months through the last dose received during the study, up to 5.5 years.
- +28 more secondary outcomes
Study Arms (1)
Single arm
OTHERInterventions
Solution for infusion for subcutaneous use according to drug use in the real world.
Eligibility Criteria
You may qualify if:
- Have received or plan to receive pegcetacoplan for the treatment of C3G or primary IC-MPGN.
- Provided signed and dated informed consent. For participants under the legal age signed and dated informed consent is provided by the participant's legally authorised representative. Assent will also be obtained from paediatric participants as required by local regulations.
You may not qualify if:
- Receiving an investigational treatment for C3G or primary IC-MPGN at the time of pegcetacoplan initiation.
- Initiated treatment with pegcetacoplan in an interventional study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Swedish Orphan Biovitrumlead
- IQVIA Pty Ltdcollaborator
Study Sites (101)
Nepean Hospital
Kingswood, 2747, Australia
Princess Alexandra Hospital
Woolloongabba, 4102, Australia
Medizinische Universität Graz
Graz, 8010, Austria
Uniklinik Innsbruck
Innsbruck, 6020, Austria
Allgemeines Krankenhaus Wien Universitätsklinik
Vienna, 1090, Austria
Klinik Ottakring
Vienna, 1140, Austria
Cliniques Universitaires Saint-Luc
Brussels, 1200, Belgium
University hosptial of Antwerpen
Edegem, 2650, Belgium
Grand Hôpital de Charleroi
Gilly, 6060, Belgium
UZ Leuven
Leuven, 3000, Belgium
Centre Hospitalier Universitaire de Liege
Liège, 4000, Belgium
CHU UCL Namur
Namur, 5000, Belgium
University of Calgary - Alberta Children's Hospital
Calgary, Alberta, T3B 6A8, Canada
British Columbia Childrens' & Women's Hospital Center
Vancouver, British Columbia, V6H 3V4, Canada
Kingston General Hospital
Kingston, Ontario, K7L 2V7, Canada
London Health Sciences Centre (LHSC) - Victoria Hospital
London, Ontario, N6A 5W9, Canada
The Hospital for Sick Children
Toronto, Ontario, M5G 1E8, Canada
University Health Network
Toronto, Ontario, M5G 2C4, Canada
McGill University
Montreal, Quebec, H3G 1A4, Canada
CHU Sainte-Justine
Montreal, Quebec, H3T 1C5, Canada
Institut klinicke a experimentalni mediciny
Prague, 14021, Czechia
Fakultni nemocnice v Motole
Prague, 16900, Czechia
CHU Bordeaux
Bordeaux, 33076, France
CHU Lyon - Hôpital Femme-Mère-Enfant
Bron, 69500, France
Hopital Henri Mondor
Créteil, 94000, France
Hopital Claude Huriez - CHU Lille
Lille, 59000, France
Hopital de la Conception - APHM
Marseille, 13005, France
Hopital Lapeyronie pt
Montpellier, 34090, France
CHU Nantes - Hôtel Dieu
Nantes, 44000, France
Hôpital Saint-Louis
Paris, 75010, France
AP-HP Georges-Pompidou European Hospital (Paris)
Paris, 75015, France
Hôpital Necker - Enfants Malades
Paris, 75015, France
Hôpital Robert Debré - Paris
Paris, 75019, France
Tenon CHU Paris Est
Paris, 75020, France
CHU Reims - Hôpital Maison Blanche
Reims, 51200, France
CHU Strasbourg - Nouvel Hôpital Civil
Strasbourg, 67000, France
Hôpital Foch
Suresnes, 92150, France
Universitaetsklinikum Aachen AOeR
Aachen, 52074, Germany
Charité - Campus Virchow-Klinikum
Berlin, 13355, Germany
University Hospital Cologne
Cologne, 50937, Germany
Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden, 1307, Germany
Universitaetsklinikum Erlangen
Erlangen, 91054, Germany
Universitaetsklinikum Essen
Essen, 45133, Germany
Universitaetsklinikum Essen
Essen, 45147, Germany
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, 20246, Germany
Medizinische Hochschule Hannover
Hanover, 30625, Germany
Universitaetsklinikum Heidelberg
Heidelberg, 69120, Germany
Universitaetsklinikum Leipzig AoeR
Leipzig, 4103, Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
Mainz, 55131, Germany
Universitaetsklinikum Regensburg
Regensburg, 93053, Germany
Robert-Bosch-Krankenhaus
Stuttgart, 70376, Germany
Nephrologisches Zentrum Villingen-Schwenningen
Villingen-Schwenningen, 78052, Germany
Nierenzentrum Wiesbaden
Wiesbaden, 65191, Germany
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
Bari, 70124, Italy
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS
Bologna, 40138, Italy
Azienda Ospedaliero Universitaria di Bologna Policlinico S Orsola Malpighi
Bologna, 40138, Italy
Ospedali Riuniti di Foggia
Foggia, 71100, Italy
Azienda Ospedaliera Universitaria Gaetano Martino
Messina, 98123, Italy
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
Milan, 20122, Italy
Ospedale Pediatrico Bambino Gesù
Roma, 165, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 168, Italy
Azienda Ospedaliero-Universitaria Santa Maria della Misericordia
Udine, 33100, Italy
King Faisal Specialist Hospital & Research Center
Jeddah, 66697, Saudi Arabia
King Faisal Specialist Hospital & Research Center
Riyadh, 11211, Saudi Arabia
King Fahad Medical City
Riyadh, 11525, Saudi Arabia
Keimyung University Dongsan Hospital
Daegu, 42601, South Korea
Chungnam National University Hospital
Daejeon, 35015, South Korea
Seoul National University Bundang Hospital
Seongnam, 13597, South Korea
Seoul National University Hospital
Seoul, 3080, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 3722, South Korea
Samsung Medical Center
Seoul, 6351, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 6591, South Korea
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul, 7061, South Korea
Complejo Hospitalario Universitario A Coruña
A Coruña, 15006, Spain
Hospital Universitari Vall d'Hebron - VHIR
Barcelona, 8024, Spain
Hospital Clinic de Barcelona
Barcelona, 8036, Spain
Hospital Sant Joan de Deu
Barcelona, 8950, Spain
Hospital Universitario de la Palma
Las Palmas, 35003, Spain
Hospital General Universitario Gregorio Marañon
Madrid, 28007, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital La Paz
Madrid, 28046, Spain
Hospital Regional Universitario de Malaga
Málaga, 29010, Spain
Hospital Doctor Peset Valencia
Valencia, 46017, Spain
Hospital Universitari i Politecnic La Fe
Valencia, 46026, Spain
University of Basel
Basel, 4031, Switzerland
Inselspital - University Hospital Bern
Bern, 3010, Switzerland
Hôpitaux Universitaires de Genève - HUG
Geneva, 1205, Switzerland
CHUV, Lausanne University Hospital
Lausanne, 1005, Switzerland
University Hospital Zurich - Children's Hospital Zurich
Zurich, 8008, Switzerland
University Hospital Zurich
Zurich, 8091, Switzerland
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 2QQ, United Kingdom
University Hospital of Wales
Cardiff, CF14 4XW, United Kingdom
Royal Hospital for Children
Glasgow, G51 4TF, United Kingdom
Leicester General Hospital
Leicester, LE1 7RH, United Kingdom
Royal Free Hospital
London, NW3 2QG, United Kingdom
Evelina London Children's Hospital
London, SE1 7EH, United Kingdom
Imperial College Healthcare NHS Trust (ICH)
London, W12 0HS, United Kingdom
Royal Manchester Children's Hospital
Manchester, M13 9WL, United Kingdom
Newcastle Hospital NHS Foundation Trust
Newcastle, NE1 4LP, United Kingdom
Salford Care Organisation
Salford, M8 8HD, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 26, 2026
First Posted
August 5, 2026
Study Start
July 9, 2026
Primary Completion (Estimated)
December 31, 2031
Study Completion (Estimated)
January 31, 2032
Last Updated
August 5, 2026
Record last verified: 2026-01