C3 Glomerulopathy (C3G), Primary Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN)Phase 3PRESERVENCT07898774
A Study to Assess the Efficacy and Safety of Pegcetacoplan for the Prevention of Recurrent C3G or Primary IC-MPGN in Kidney Transplant Recipients
A Phase 3 study testing Pegcetacoplan in people with C3 Glomerulopathy (C3G), Primary Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) and Recurrent Glomerular Disease After Kidney Transplantation, run by Swedish Orphan Biovitrum at 33 sites in 10 countries.
Trial summary
To assess the efficacy and safety of pegcetacoplan for the prevention of recurrent C3G or primary IC-MPGN in kidney transplant recipients Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- C3 Glomerulopathy (C3G), Primary Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN), Recurrent Glomerular Disease After Kidney Transplantation
- What is being tested?
- Pegcetacoplan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 33 sitesin 10 countries
- Study dates
- 21 Jan 2027to 17 Jan 2031
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
33 sites in 10 countries. Contact the study team or a site near you to ask about taking part.
33 sites in 10 countries
France6 sites
Hopital Claude Huriez - CHU Lille
Lille, Nord, 59037
Hopital Edouard Herriot - CHU Lyon
Lyon, Rhone, 69437
Hopital Lapeyronie pt
Montpellier, Herault, 34000
Hôpital Necker - Enfants Malades
Paris, Paris, 75015
CHU Strasbourg - Nouvel Hôpital Civil
Strasbourg, Bas Rhin, 67091
Hopital Rangueil
Toulouse, Haute Garonne, 31059
Canada5 sites
University of Alberta - Faculty of Medicine & Dentistry
Edmonton, Alberta, T6G 2R7
London Health Sciences Centre (LHSC) - University Hospital
London, Ontario, N6A 5A5
McGill University Health Centre Research Institute
Montreal, Quebec, H4A 3J1
Toronto General Hospital
Toronto, Ontario, M5G 2C4
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
Spain5 sites
Complejo Hospitalario Universitario A Coruña
A Coruña, La Coruña, 15006
Hospital de Cruces
Barakaldo, Vizcaya, 48903
Hospital Universitari Vall d'Hebron - VHIR
Barcelona, Barcelona, 8035
Hospital Universitario 12 de Octubre
Madrid, Madrid, 28041
Hospital Regional Universitario de Malaga
Málaga, Málaga, 29010
Italy4 sites
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
Bari, Bari, 70124
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)
Bergamo, Bergamo, 24127
Ospedale Pediatrico Bambino Gesù
Roma, Roma, 165
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Roma, 168
United Kingdom4 sites
Royal Free Hospital
London, Greater London, NW3 2QG
Hammersmith Hospital
London, Greater London, W12 0HS
Manchester Royal Infirmary
Manchester, Greater Manchester, M13 9WL
Freeman Hospital
Newcastle upon Tyne, Tyne & Wear, NE7 7DN
Brazil3 sites
UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu
Botucatu, São Paulo, 18618-970
Real Hospital Português
Recife, Pernambuco, 52010-010
Hospital das Clinicas da Faculdade de Medicina da USP - HCFMUSP
São Paulo, São Paulo, 05403-000
Germany3 sites
Universitaetsklinikum Koeln
Cologne, North Rhine-Westphalia, 50937
Universitaetsklinikum Essen
Essen, North Rhine-Westphalia, 45147
Medizinische Hochschule Hannover
Hanover, Lower Saxony, 30625
Saudi Arabia1 site
King Faisal Specialist Hospital & Research Center
Riyadh, 11211
Switzerland1 site
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, 1011
About this study
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
To assess the efficacy and safety of pegcetacoplan for the prevention of recurrent C3G or primary IC-MPGN in kidney transplant recipients
Read the detailed description
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 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.
- Conditions
- C3 Glomerulopathy (C3G), Primary Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN), Recurrent Glomerular Disease After Kidney Transplantation
- Being tested
- Pegcetacoplan
- Keywords
- C3 Glomerulopathy (C3G), Primary IC-MPGN, Pegcetacoplan, Disease Recurrence, Complement Inhibition, Kidney Allograft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PegcetacoplanDrug
Also called Aspaveli, Empaveli, APL-2
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 group | Role | What they receive |
|---|---|---|
| Pegcetacoplan | Experimental | Pegcetacoplan, a complement C3/C3b inhibitor, administered according to the study protocol in kidney transplant recipients with high risk of recurring C3G or primary IC-MPGN Receives: Drug: Pegcetacoplan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Clinically Significant Recurrent Disease
Histological evidence of recurrent disease based on the histopathological assessment of the kidney biopsy
Measured: Within 2 years after kidney transplantation
Secondary outcomes (1)
Time to Onset of Clinically Significant Disease Recurrence
To explore the impact of pegcetacoplan on time to clinically significant recurrence of C3G or primary IC-MPGN after kidney transplantation
Measured: Up to 2 years after kidney transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start21 Jan 2027 (estimated)
- Primary completion17 Jan 2031 (estimated)
- Study completion17 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for C3 Glomerulopathy (C3G), Primary Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN)Studies of the same condition, open and under way.
- More trials run by Swedish Orphan BiovitrumThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants receive pegcetacoplan in addition to standard post-transplant care. The study explores the safety and efficacy of pegcetacoplan in preventing disease recurrence of C3 glomerulopathy (C3G) or primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN) following kidney transplantation
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Swedish Orphan Biovitrum
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IQVIA Pty Ltd
- Responsible party
- Sponsor
- Investigators
- Study Physician, Study director, Swedish Orphan Biovitrum AB (publ)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07898774
- Sponsor's protocol ID
- Sobi.PEGCET-404
- Other IDs
- 2026-526392-39-00
- Acronym
- PRESERVE
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents. All requests are evaluated by a cross functional panel of experts within Sobi. Patient level data will be anonymized and study documents, if applicable, will be redacted to protect the privacy of trial participants.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07898774
- Acronym / sponsor ID
- PRESERVE / Sobi.PEGCET-404
- Conditions
- C3 Glomerulopathy (C3G), Primary Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN), Recurrent Glomerular Disease After Kidney Transplantation
- Keywords
- C3 Glomerulopathy (C3G), Primary IC-MPGN, Pegcetacoplan, Disease Recurrence, Complement Inhibition, Kidney Allograft
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Swedish Orphan BiovitrumIndustry (pharma, biotech, devices)
- Collaborators
- IQVIA Pty Ltd
- Study start
- 21 Jan 2027 (estimated)
- Primary completion
- 17 Jan 2031 (estimated)
- Study completion
- 17 Jan 2031 (estimated)
- First posted
- 27 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the efficacy and safety of pegcetacoplan for the prevention of recurrent C3G or primary IC-MPGN in kidney transplant recipients
Detailed description
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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants receive pegcetacoplan in addition to standard post-transplant care. The study explores the safety and efficacy of pegcetacoplan in preventing disease recurrence of C3 glomerulopathy (C3G) or primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN) following kidney transplantation
| Arm | Type | Receives |
|---|---|---|
| Pegcetacoplan | Experimental | Drug: PegcetacoplanPegcetacoplan, a complement C3/C3b inhibitor, administered according to the study protocol in kidney transplant recipients with high risk of recurring C3G or primary IC-MPGN |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PegcetacoplanAlso: Aspaveli, Empaveli, APL-2Dose 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 | Drug | Pegcetacoplan |
Primary outcome
Occurrence of Clinically Significant Recurrent Disease
Time frame: Within 2 years after kidney transplantation
Histological evidence of recurrent disease based on the histopathological assessment of the kidney biopsy
1 secondary outcome
Time to Onset of Clinically Significant Disease Recurrence
Time frame: Up to 2 years after kidney transplantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents. All requests are evaluated by a cross functional panel of experts within Sobi. Patient level data will be anonymized and study documents, if applicable, will be redacted to protect the privacy of trial participants.
Related trials for C3 Glomerulopathy (C3G), Primary Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN)
Not yet recruitingObservational study
Pilot STUDY to Monitor Ex-vivo the Biological Effects of the C3 Inhibitor, PEGCETACOPLAN, on Activation of Complement in Fluid Phase and on Podocytes in Patients With C3G and Primary IC-MPGN
Glomerulopathy, C3G
RecruitingPhase 4
Real-World Effectiveness and Safety of Pegcetacoplan in Patients With C3G or IC-MPG: A Multi-Country Study
C3 Glomerulopathy (C3G), Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN)
Not yet recruitingPhase 2
Phase II Clinical Study on the Efficacy and Safety of QLS7305 in Patients With Kidney Disease (Part A)
IgAN - IgA Nephropathy, Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Study Physician study director
Swedish Orphan Biovitrum AB (publ)
33 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pegcetacoplan in people with C3 Glomerulopathy (C3G), Primary Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) and Recurrent Glomerular Disease After Kidney Transplantation, run by Swedish Orphan Biovitrum at 33 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in France, Canada, Spain, Italy, United Kingdom and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Physician (+46 86972000, medical.info@sobi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Clinically Significant Recurrent Disease (time frame: Within 2 years after kidney transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.