Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Starting soon Phase 3

To Assess the Efficacy and Safety of Pegcetacoplan for the Prevention of Recurrent C3G or Primary IC-MPGN in Kidney Transplant Recipients

NCT07898774 · tracked via the Priya Life Science UK tracker
Phase
Phase 3
Started
2027-01-21
Last updated
2026-10-27

Condition(s) studied

C3 Glomerulopathy (C3G)Primary Immune-Complex MembranoproliferativeGlomerulonephritis (IC-MPGN)Kidney TransplantationRecurrent Glomerular Disease After Kidney Transplantation

Investigational drug(s) / intervention(s)

Pegcetacoplan →

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

Study summary

To assess the efficacy and safety of pegcetacoplan for the prevention of recurrent C3G or primary IC-MPGN in kidney transplant recipients

Eligibility

Sex
ALL
Min age
12 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Male or female patients with a diagnosis of C3 glomerulopathy (C3G) or primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN) who are planning to undergo kidney transplantation because of the disease. * High risk of disease recurrence following kidney transplantation, defined by either: Previous kidney allograft loss due to recurrent C3G or primary IC-MPGN, or investigator assessment of high recurrence risk based on clinical information. * Up to date with vaccinations against Neisseria meningitidis, Streptococcus pneumoniae, and Haemophilus influenzae type B, in accordance with local requirements, before initiation of pegcetacoplan. Exclusion Criteria: * A known secondary cause for MPGN, including but not limited to monoclonal gammopathy of clinical significance, hepatitis B, hepatitis C, or autoimmune cryoglobulinemia. * History of invasive meningococcal disease. * History of malignancy, except for the following: cured basal or squamous cell skin cancer, curatively treated in situ disease, or currently malignancy-free and has been off-treatment for the malignancy for at least 5 years. * Hypersensitivity to pegcetacoplan or any of its excipients. * Known or suspected hereditary fructose intolerance. * Any other medical condition which, in the opinion of the Investigator, makes the participant unsuitable for inclusion. * Use of a complement inhibitor for the treatment of C3G or primary IC-MPGN within 1 month prior to the scheduled kidney transplantation surgery.

Primary outcome measure(s)

  • Occurrence of Clinically Significant Recurrent Disease — Within 2 years after kidney transplantation
    Occurrence of clinically significant recurrent C3 glomerulopathy (C3G) or primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN) following kidney transplantation.

Trial sites (33)

FacilityCityRegionStatus
Real Hospital Português Recife Pernambuco
UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu Botucatu São Paulo
Hospital das Clinicas da Faculdade de Medicina da USP - HCFMUSP São Paulo São Paulo
University of Alberta - Faculty of Medicine & Dentistry Edmonton Alberta
St. Paul's Hospital Vancouver British Columbia
London Health Sciences Centre (LHSC) - University Hospital London Ontario
Toronto General Hospital Toronto Ontario
McGill University Health Centre Research Institute Montreal Quebec
Helsinki University Central Hospital Helsinki Finland
CHU Strasbourg - Nouvel Hôpital Civil Strasbourg Bas Rhin
Hopital Rangueil Toulouse Haute Garonne
Hopital Lapeyronie pt Montpellier Herault
Hopital Claude Huriez - CHU Lille Lille Nord
Hôpital Necker - Enfants Malades Paris Paris
Hopital Edouard Herriot - CHU Lyon Lyon Rhone
Medizinische Hochschule Hannover Hanover Lower Saxony
Universitaetsklinikum Koeln Cologne North Rhine-Westphalia
Universitaetsklinikum Essen Essen North Rhine-Westphalia
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari Bari Bari
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII) Bergamo Bergamo
Ospedale Pediatrico Bambino Gesù Roma Roma
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Roma Roma
King Faisal Specialist Hospital & Research Center Riyadh Saudi Arabia
Hospital Universitari Vall d'Hebron - VHIR Barcelona Barcelona
Complejo Hospitalario Universitario A Coruña A Coruña La Coruña
Hospital Universitario 12 de Octubre Madrid Madrid
Hospital Regional Universitario de Malaga Málaga Málaga
Hospital de Cruces Barakaldo Vizcaya
Centre Hospitalier Universitaire Vaudois (CHUV) Lausanne Switzerland
Royal Free Hospital London Greater London
Hammersmith Hospital London Greater London
Manchester Royal Infirmary Manchester Greater Manchester
Freeman Hospital Newcastle upon Tyne Tyne & Wear
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07898774 on ClinicalTrials.gov ↗ ← All trials in the UK