Pegcetacoplan to prevent recurrence of C3G/IC-MPGN after kidney transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The PRESERVE study is a phase 3b, multicenter, single-arm, open-label trial assessing pegcetacoplan added to standard post-transplant care to see if it can delay or prevent recurrence of C3G or IC-MPGN after kidney transplantation. Participants receive pegcetacoplan starting at transplantation and are followed to monitor disease recurrence, kidney function, graft outcomes, safety, and tolerability. The study targets patients with a history or high risk of recurrence and who are fully vaccinated according to local guidelines. Outcomes will help determine if early complement inhibition can improve long-term graft survival in this high-risk population.

Why it matters

Who can join: the full rules

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.
* Have a high risk of disease recurrence following kidney transplantation, based on either having a previous kidney allograft loss due to recurrence of C3G or primary IC-MPGN, or assessed as having a high risk by the investigator based on other clinical information.
* Is fully vaccinated and up to date with their vaccinations against Neisseria meningitidis, Streptococcus pneumoniae, and Haemophilus influenzae type B, in accordance with local guidelines, at the time of initiating 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.

Where it's running

• Hammersmith Hospital
  London, Greater London, United Kingdom Recruiting
• Real Hospital Português
  Recife, Pernambuco, Brazil Not yet recruiting
• UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
  Botucatu, São Paulo, Brazil Not yet recruiting
• Hospital das Clinicas da Faculdade de Medicina da USP - HCFMUSP
  São Paulo, São Paulo, Brazil Not yet recruiting
• University of Alberta - Faculty of Medicine & Dentistry
  Edmonton, Alberta, Canada Not yet recruiting
• St. Paul's Hospital
  Vancouver, British Columbia, Canada Not yet recruiting

Study contacts

• Study coordinator: Study Physician
• Email: medical.info@sobi.com
• Phone: +46 86972000

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Pegcetacoplan in real-world C3G and IC-MPGN patients

  This study tests pegcetacoplan's safety and effectiveness in people with C3 glomerulopathy or primary IC-MPGN in real-world practice.

  Recruiting at 4 sites Phase 4 Swedish Orphan Biovitrum · Kingswood and 100 other locations · NCT07746895

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.