Real-World Effectiveness and Safety of Pegcetacoplan in Patients With C3G or IC-MPG: A Multi-Country Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pegcetacoplan.
- Who it may be relevant to
- Registry conditions: C3 Glomerulopathy (C3G), Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN). Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia, Austria, Belgium, Canada, Czechia +9
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Real-World Effectiveness and Safety of Pegcetacoplan in Patients With C3 Glomerulopathy (C3G) or Primary Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN): A Multi-Country Study
Overview
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.
Detailed description
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 post-approval, as well as to characterise relevant biomarkers and their association with pegcetacoplan treatment. This will provide new information that was not evaluated in the clinical programme and help with understanding the long-term benefit-risk of pegcetacoplan in a broad patient population. This study will evaluate patient data prior to, during and after the use of pegcetacoplan to assess how the real-world use of pegcetacoplan impacts clinical outcomes and health care resource utilisation. This knowledge will contribute to informed clinical decision-making and provide guidance for effective disease management of patients with C3G or primary IC-MPGN.
Interventions
- Drug Pegcetacoplan
Solution for infusion for subcutaneous use according to drug use in the real world.
Primary outcome measures
- Achieving urine protein-to-creatinine ratio (UPCR) of <1 g/g [Time frame: at 6 months after starting pegcetacoplan treatment]
Secondary outcome measures (12)
- Participant demographics (age, sex, race) [Time frame: Day 1 of treatment/Baseline.]
- Clinical characteristics of renal disease (UPCR) [Time frame: Prior to and - Day 1 of treatment/Baseline.]
- Clinical characteristics of renal disease (eGFR) [Time frame: Prior to and - Day 1 of treatment/Baseline.]
- Prior and concomitant C3G and primary IC-MPGN treatment information [Time frame: Day 1 of treatment/Baseline.]
- ≥50% proteinuria reduction [Time frame: At 1, 3, 6, 12 months and then every 6 months through the last dose received during the study, up to 5.5 years.]
- <1 g/g UPCR [Time frame: At 1, 3, 6, 12 months and then every 6 months through the last dose received during the study, up to 5.5 years.]
- <0.5 g/g UPCR among participants aged 18 years or older [Time frame: At 1, 3, 6, 12 months and then every 6 months through the last dose received during the study, up to 5.5 years.]
- <0.2 g/g UPCR among participants less than 18 years of age [Time frame: Whenever the event occurs for the first time during pegcetacoplan treatment, up to 5.5 years.]
- Resolution of nephrotic syndrome in those with nephrotic syndrome [Time frame: Whenever the event occurs for the first time during pegcetacoplan treatment, up to 5.5 years.]
- Sustained doubling of serum creatinine [Time frame: Whenever the event occurs for the first time during pegcetacoplan treatment, up to 5.5 years.]
- Progression to Chronic Kidney Disease Stage 5 or ESRD [Time frame: At occurrence, prior to and during pegcetacoplan treatment, up to 5.5 years.]
- Receipt of new kidney transplant [Time frame: At occurrence, prior to and during pegcetacoplan treatment, up to 5.5 years.]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- Receiving an investigational treatment for C3G or primary IC-MPGN at the time of pegcetacoplan initiation.
- Initiated treatment with pegcetacoplan in an interventional study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Germany · 16 centers
- Universitaetsklinikum Aachen AOeR — Aachen
- Charité - Campus Virchow-Klinikum — Berlin
- University Hospital Cologne — Cologne
- Universitaetsklinikum Carl Gustav Carus TU Dresden — Dresden
- Universitaetsklinikum Erlangen — Erlangen
- Universitaetsklinikum Essen — Essen
- Universitaetsklinikum Essen — Essen
- Universitaetsklinikum Hamburg-Eppendorf — Hamburg
- … and 8 more centers
France · 15 centers
- CHU Bordeaux — Bordeaux
- CHU Lyon - Hôpital Femme-Mère-Enfant — Bron
- Hopital Henri Mondor — Créteil
- Hopital Claude Huriez - CHU Lille — Lille
- Hopital de la Conception - APHM — Marseille
- Hopital Lapeyronie pt — Montpellier
- CHU Nantes - Hôtel Dieu — Nantes
- Hôpital Saint-Louis — Paris
- … and 7 more centers
Spain · 11 centers
- Complejo Hospitalario Universitario A Coruña — A Coruña
- Hospital Universitari Vall d'Hebron - VHIR — Barcelona
- Hospital Clinic de Barcelona — Barcelona
- Hospital Sant Joan de Deu — Barcelona
- Hospital Universitario de la Palma — Las Palmas
- Hospital General Universitario Gregorio Marañon — Madrid
- Hospital Universitario 12 de Octubre — Madrid
- … and 4 more centers
United Kingdom · 10 centers
Center list to be confirmed — check the primary protocol.
Italy · 9 centers
- Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari — Bari
- Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS — Bologna
- Azienda Ospedaliero Universitaria di Bologna Policlinico S Orsola Malpighi — Bologna
- Ospedali Riuniti di Foggia — Foggia
- Azienda Ospedaliera Universitaria Gaetano Martino — Messina
- Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico — Milan
- Ospedale Pediatrico Bambino Gesù — Roma
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Roma
- … and 1 more center
Canada · 8 centers
- University of Calgary - Alberta Children's Hospital — Calgary
- British Columbia Childrens' & Women's Hospital Center — Vancouver
- Kingston General Hospital — Kingston
- London Health Sciences Centre (LHSC) - Victoria Hospital — London
- The Hospital for Sick Children — Toronto
- University Health Network — Toronto
- McGill University — Montreal
- CHU Sainte-Justine — Montreal
South Korea · 8 centers
- Keimyung University Dongsan Hospital — Daegu
- Chungnam National University Hospital — Daejeon
- Seoul National University Bundang Hospital — Seongnam
- Seoul National University Hospital — Seoul
- Severance Hospital, Yonsei University Health System — Seoul
- Samsung Medical Center — Seoul
- The Catholic University of Korea, Seoul St. Mary's Hospital — Seoul
- Seoul Metropolitan Government Seoul National University Boramae Medical Center — Seoul
Belgium · 6 centers
- Cliniques Universitaires Saint-Luc — Brussels
- University hosptial of Antwerpen — Edegem
- Grand Hôpital de Charleroi — Gilly
- UZ Leuven — Leuven
- Centre Hospitalier Universitaire de Liege — Liège
- CHU UCL Namur — Namur
Switzerland · 6 centers
Center list to be confirmed — check the primary protocol.
Austria · 4 centers
- Medizinische Universität Graz — Graz
- Uniklinik Innsbruck — Innsbruck
- Allgemeines Krankenhaus Wien Universitätsklinik — Vienna
- Klinik Ottakring — Vienna
Saudi Arabia · 3 centers
- King Faisal Specialist Hospital & Research Center — Jeddah
- King Faisal Specialist Hospital & Research Center — Riyadh
- King Fahad Medical City — Riyadh
Australia · 2 centers
- Nepean Hospital — Kingswood
- Princess Alexandra Hospital — Woolloongabba
Czechia · 2 centers
- Institut klinicke a experimentalni mediciny — Prague
- Fakultni nemocnice v Motole — Prague
Taiwan · 1 center
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07746895 · Sobi.PEGCET-402 · 2025-524487-37-00