Real-World Effectiveness and Safety of Pegcetacoplan in Patients With C3G or IC-MPG: A Multi-Country Study
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Pegcetacoplan.
- Кому может быть актуально
- Состояния в реестре: C3 Glomerulopathy (C3G), Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN). Базовые параметры: Без ограничений · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Австралия, Австрия, Бельгия, Канада, Чехия +9
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
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
Обзор
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.
Подробное описание
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.
Вмешательства
- Препарат Pegcetacoplan
Solution for infusion for subcutaneous use according to drug use in the real world.
Первичные конечные точки
- Achieving urine protein-to-creatinine ratio (UPCR) of <1 g/g [Срок оценки: at 6 months after starting pegcetacoplan treatment]
Вторичные конечные точки (12)
- Participant demographics (age, sex, race) [Срок оценки: Day 1 of treatment/Baseline.]
- Clinical characteristics of renal disease (UPCR) [Срок оценки: Prior to and - Day 1 of treatment/Baseline.]
- Clinical characteristics of renal disease (eGFR) [Срок оценки: Prior to and - Day 1 of treatment/Baseline.]
- Prior and concomitant C3G and primary IC-MPGN treatment information [Срок оценки: Day 1 of treatment/Baseline.]
- ≥50% proteinuria reduction [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Whenever the event occurs for the first time during pegcetacoplan treatment, up to 5.5 years.]
- Sustained doubling of serum creatinine [Срок оценки: 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 [Срок оценки: At occurrence, prior to and during pegcetacoplan treatment, up to 5.5 years.]
- Receipt of new kidney transplant [Срок оценки: At occurrence, prior to and during pegcetacoplan treatment, up to 5.5 years.]
Критерии участия
Критерии включения
- 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.
Критерии исключения
- Receiving an investigational treatment for C3G or primary IC-MPGN at the time of pegcetacoplan initiation.
- Initiated treatment with pegcetacoplan in an interventional study.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Германия · 16 центров
- 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
- … и ещё 8 центров
Франция · 15 центров
- 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
- … и ещё 7 центров
Испания · 11 центров
- 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
- … и ещё 4 центра
Великобритания · 10 центров
Список центров уточняется — проверьте первичный протокол.
Италия · 9 центров
- 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
- … и ещё 1 центр
Канада · 8 центров
- 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 центров
- 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
Бельгия · 6 центров
- 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
Швейцария · 6 центров
Список центров уточняется — проверьте первичный протокол.
Австрия · 4 центра
- Medizinische Universität Graz — Graz
- Uniklinik Innsbruck — Innsbruck
- Allgemeines Krankenhaus Wien Universitätsklinik — Vienna
- Klinik Ottakring — Vienna
Саудовская Аравия · 3 центра
- King Faisal Specialist Hospital & Research Center — Jeddah
- King Faisal Specialist Hospital & Research Center — Riyadh
- King Fahad Medical City — Riyadh
Австралия · 2 центра
- Nepean Hospital — Kingswood
- Princess Alexandra Hospital — Woolloongabba
Чехия · 2 центра
- Institut klinicke a experimentalni mediciny — Prague
- Fakultni nemocnice v Motole — Prague
Тайвань · 1 центр
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT07746895 · Sobi.PEGCET-402 · 2025-524487-37-00