Last updated 4 days ago
To Assess the Efficacy and Safety of Pegcetacoplan for the Prevention of Recurrent C3G or Primary IC-MPGN in Kidney Transplant Recipients
30 patients around the world
Available in Spain, Brazil
The PRESERVE study is a Phase 3b, multicenter, single-arm, open-label clinical trial designed to explore the efficacy and safety of pegcetacoplan in preventing or delaying the recurrence of C3 glomerulopathy (C3G) or primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN) following kidney transplantation. Recurrence of these diseases after transplantation is common and can lead to graft dysfunction and loss. Pegcetacoplan is a complement C3/C3b inhibitor that has demonstrated activity in patients with native kidney undermine disease and recurrent disease after transplantation. The study aims to assess whether initiating pegcetacoplan at the time of kidney transplantation, before recurrence occurs, may delay the recurrence and support long-term graft outcomes. Participants will receive pegcetacoplan in addition to standard post-transplant care and will be followed to evaluate disease recurrence, kidney function, graft outcomes, safety, and tolerability.
Swedish Orphan Biovitrum
3Research sites
30Patients around the world
This study is for people with
Kidney Transplant
Requirements for the patient
From 12 Years
All Gender
Medical requirements
- 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.
- 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.
Sites
Real Hospital Português de Beneficência em Pernambuco
Faculdade de Medicina da Universidade Estadual Paulista - Campus de Botucatu - UNESP
Hospital das Clínicas da Faculdade de Medicina da São Paulo - FMUSP
StudyPRESERVE
SponsorSwedish Orphan Biovitrum
Study typeInterventional
Conditions
Kidney Transplant
Requirements
From 12 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07898774
