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To Assess the Efficacy and Safety of Pegcetacoplan for the Prevention of Recurrent C3G or Primary IC-MPGN in Kidney Transplant Recipients
Sponsor: Swedish Orphan Biovitrum
Summary
To assess the efficacy and safety of pegcetacoplan for the prevention of recurrent C3G or primary IC-MPGN in kidney transplant recipients
Official title: A 2-year, Single-arm, Multi-center Study to Explore the Efficacy and Safety of Pegcetacoplan in Preventing Disease Recurrence in Adolescent and Adult Kidney Transplant Recipients With C3 Glomerulopathy or Primary Immune-complex Membranoproliferative Glomerulonephritis
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2027-01-21
Completion Date
2031-01-17
Last Updated
2026-10-27
Healthy Volunteers
No
Conditions
Interventions
Pegcetacoplan
Dose amount based on age and weight Subcutaneous infusion twice-a-week. Adult participants aged 18 years or older at enrolment: 1080 mg Adolescent participants aged 12 to 17 years at enrolment: * Weight ≥50 kg: 1080 mg * Weight 35 to \<50 kg: 648 mg 1st dose, then 810 mg subsequently * Weight 30 to \<35 kg: 540 mg for the first 2 doses, then 648 mg subsequently
Locations (33)
Real Hospital Português
Recife, Pernambuco, Brazil
UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
Botucatu, São Paulo, Brazil
Hospital das Clinicas da Faculdade de Medicina da USP - HCFMUSP
São Paulo, São Paulo, Brazil
University of Alberta - Faculty of Medicine & Dentistry
Edmonton, Alberta, Canada
St. Paul's Hospital
Vancouver, British Columbia, Canada
London Health Sciences Centre (LHSC) - University Hospital
London, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
McGill University Health Centre Research Institute
Montreal, Quebec, Canada
Helsinki University Central Hospital
Helsinki, Finland
CHU Strasbourg - Nouvel Hôpital Civil
Strasbourg, Bas Rhin, France
Hopital Rangueil
Toulouse, Haute Garonne, France
Hopital Lapeyronie pt
Montpellier, Herault, France
Hopital Claude Huriez - CHU Lille
Lille, Nord, France
Hôpital Necker - Enfants Malades
Paris, Paris, France
Hopital Edouard Herriot - CHU Lyon
Lyon, Rhone, France
Medizinische Hochschule Hannover
Hanover, Lower Saxony, Germany
Universitaetsklinikum Koeln
Cologne, North Rhine-Westphalia, Germany
Universitaetsklinikum Essen
Essen, North Rhine-Westphalia, Germany
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
Bari, Bari, Italy
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)
Bergamo, Bergamo, Italy
Ospedale Pediatrico Bambino Gesù
Roma, Roma, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Roma, Italy
King Faisal Specialist Hospital & Research Center
Riyadh, Saudi Arabia
Hospital Universitari Vall d'Hebron - VHIR
Barcelona, Barcelona, Spain
Complejo Hospitalario Universitario A Coruña
A Coruña, La Coruña, Spain
Hospital Universitario 12 de Octubre
Madrid, Madrid, Spain
Hospital Regional Universitario de Malaga
Málaga, Málaga, Spain
Hospital de Cruces
Barakaldo, Vizcaya, Spain
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Switzerland
Royal Free Hospital
London, Greater London, United Kingdom
Hammersmith Hospital
London, Greater London, United Kingdom
Manchester Royal Infirmary
Manchester, Greater Manchester, United Kingdom
Freeman Hospital
Newcastle upon Tyne, Tyne & Wear, United Kingdom