C3 Glomerulopathy (C3G)Phase 4NCT07746895

Real-World Effectiveness and Safety of Pegcetacoplan in Patients With C3G or IC-MPG: A Multi-Country Study

A Phase 4 study testing Pegcetacoplan in people with C3 Glomerulopathy (C3G) and Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN), run by Swedish Orphan Biovitrum at 101 sites in 14 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial summary

Who is it for?: Any age
Conditions the study is for: C3 Glomerulopathy (C3G), Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN)
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: 150 participants
Where: 101 sitesin 14 countries
Study dates: 5 Aug 2026to 31 Jan 2032
Phase: Phase 4
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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Have received or plan to receive pegcetacoplan for the treatment of C3G or primary IC-MPGN.
Provided signed and dated informed consent. For participants under the legal age signed and dated informed consent is provided by the participant's legally authorised representative. Assent will also be obtained from paediatric participants as required by local regulations.

Who cannot join

Receiving an investigational treatment for C3G or primary IC-MPGN at the time of pegcetacoplan initiation.
Initiated treatment with pegcetacoplan in an interventional study.

Trial locations and contacts

101 sites in 14 countries. Contact the study team or a site near you to ask about taking part.

Study Physician contact

+46 86972000

medical.info@sobi.com

Country

City, postcode or hospital

Sites recruiting now only

101 sites in 14 countries

Germany16 sites, 16 recruiting

Universitaetsklinikum Aachen AOeR
Aachen, 52074
Not yet recruiting
Charité - Campus Virchow-Klinikum
Berlin, 13355
Not yet recruiting
University Hospital Cologne
Cologne, 50937
Not yet recruiting
Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden, 1307
Not yet recruiting
Universitaetsklinikum Erlangen
Erlangen, 91054
Not yet recruiting
Universitaetsklinikum Essen
Essen, 45133
Not yet recruiting
Universitaetsklinikum Essen
Essen, 45147
Not yet recruiting
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, 20246
Not yet recruiting
Medizinische Hochschule Hannover
Hanover, 30625
Not yet recruiting
Universitaetsklinikum Heidelberg
Heidelberg, 69120
Not yet recruiting
Universitaetsklinikum Leipzig AoeR
Leipzig, 4103
Not yet recruiting
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
Mainz, 55131
Not yet recruiting
Universitaetsklinikum Regensburg
Regensburg, 93053
Not yet recruiting
Robert-Bosch-Krankenhaus
Stuttgart, 70376
Recruiting
Nephrologisches Zentrum Villingen-Schwenningen
Villingen-Schwenningen, 78052
Not yet recruiting
Nierenzentrum Wiesbaden
Wiesbaden, 65191
Not yet recruiting

Other trials in Germany

France15 sites, 15 recruiting

CHU Bordeaux
Bordeaux, 33076
Not yet recruiting
CHU Lyon - Hôpital Femme-Mère-Enfant
Bron, 69500
Not yet recruiting
Hopital Henri Mondor
Créteil, 94000
Not yet recruiting
Hopital Claude Huriez - CHU Lille
Lille, 59000
Not yet recruiting
Hopital de la Conception - APHM
Marseille, 13005
Not yet recruiting
Hopital Lapeyronie pt
Montpellier, 34090
Not yet recruiting
CHU Nantes - Hôtel Dieu
Nantes, 44000
Not yet recruiting
Hôpital Saint-Louis
Paris, 75010
Not yet recruiting
AP-HP Georges-Pompidou European Hospital (Paris)
Paris, 75015
Not yet recruiting
Hôpital Necker - Enfants Malades
Paris, 75015
Not yet recruiting
Hôpital Robert Debré - Paris
Paris, 75019
Not yet recruiting
Tenon CHU Paris Est
Paris, 75020
Not yet recruiting
CHU Reims - Hôpital Maison Blanche
Reims, 51200
Not yet recruiting
CHU Strasbourg - Nouvel Hôpital Civil
Strasbourg, 67000
Not yet recruiting
Hôpital Foch
Suresnes, 92150
Not yet recruiting

Other trials in France

Spain11 sites, 11 recruiting

Complejo Hospitalario Universitario A Coruña
A Coruña, 15006
Catuxa Rodriguez
Catuxa Rodriguez
Recruiting
Hospital Universitari Vall d'Hebron - VHIR
Barcelona, 8024
Not yet recruiting
Hospital Clinic de Barcelona
Barcelona, 8036
Not yet recruiting
Hospital Sant Joan de Deu
Barcelona, 8950
Not yet recruiting
Hospital Universitario de la Palma
Las Palmas, 35003
Not yet recruiting
Hospital General Universitario Gregorio Marañon
Madrid, 28007
Not yet recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
Not yet recruiting
Hospital La Paz
Madrid, 28046
Not yet recruiting
Hospital Regional Universitario de Malaga
Málaga, 29010
Not yet recruiting
Hospital Doctor Peset Valencia
Valencia, 46017
Not yet recruiting
Hospital Universitari i Politecnic La Fe
Valencia, 46026
Not yet recruiting

Other trials in Spain

United Kingdom10 sites, 10 recruiting

Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 2QQ
Not yet recruiting
University Hospital of Wales
Cardiff, CF14 4XW
Not yet recruiting
Royal Hospital for Children
Glasgow, G51 4TF
Not yet recruiting
Leicester General Hospital
Leicester, LE1 7RH
Not yet recruiting
Royal Free Hospital
London, NW3 2QG
Not yet recruiting
Evelina London Children's Hospital
London, SE1 7EH
Not yet recruiting
Imperial College Healthcare NHS Trust (ICH)
London, W12 0HS
Not yet recruiting
Royal Manchester Children's Hospital
Manchester, M13 9WL
Not yet recruiting
Newcastle Hospital NHS Foundation Trust
Newcastle, NE1 4LP
Not yet recruiting
Salford Care Organisation
Salford, M8 8HD
Not yet recruiting

Other trials in United Kingdom

Italy9 sites, 9 recruiting

Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
Bari, 70124
Not yet recruiting
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS
Bologna, 40138
Not yet recruiting
Azienda Ospedaliero Universitaria di Bologna Policlinico S Orsola Malpighi
Bologna, 40138
Not yet recruiting
Ospedali Riuniti di Foggia
Foggia, 71100
Not yet recruiting
Azienda Ospedaliera Universitaria Gaetano Martino
Messina, 98123
Not yet recruiting
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
Milan, 20122
Not yet recruiting
Ospedale Pediatrico Bambino Gesù
Roma, 165
Not yet recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 168
Not yet recruiting
Azienda Ospedaliero-Universitaria Santa Maria della Misericordia
Udine, 33100
Not yet recruiting

Other trials in Italy

Canada8 sites, 8 recruiting

University of Calgary - Alberta Children's Hospital
Calgary, Alberta, T3B 6A8
Not yet recruiting
Kingston General Hospital
Kingston, Ontario, K7L 2V7
Not yet recruiting
London Health Sciences Centre (LHSC) - Victoria Hospital
London, Ontario, N6A 5W9
Not yet recruiting
McGill University
Montreal, Quebec, H3G 1A4
Not yet recruiting
CHU Sainte-Justine
Montreal, Quebec, H3T 1C5
Not yet recruiting
The Hospital for Sick Children
Toronto, Ontario, M5G 1E8
Not yet recruiting
University Health Network
Toronto, Ontario, M5G 2C4
Not yet recruiting
British Columbia Childrens' & Women's Hospital Center
Vancouver, British Columbia, V6H 3V4
Not yet recruiting

Other trials in Canada

South Korea8 sites, 8 recruiting

Keimyung University Dongsan Hospital
Daegu, 42601
Recruiting
Chungnam National University Hospital
Daejeon, 35015
Not yet recruiting
Seoul National University Bundang Hospital
Seongnam, 13597
Not yet recruiting
Seoul National University Hospital
Seoul, 3080
Not yet recruiting
Severance Hospital, Yonsei University Health System
Seoul, 3722
Not yet recruiting
Samsung Medical Center
Seoul, 6351
Not yet recruiting
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 6591
Not yet recruiting
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul, 7061
Not yet recruiting

Other trials in South Korea

Belgium6 sites, 6 recruiting

Cliniques Universitaires Saint-Luc
Brussels, 1200
Not yet recruiting
University hosptial of Antwerpen
Edegem, 2650
Not yet recruiting
Grand Hôpital de Charleroi
Gilly, 6060
Not yet recruiting
UZ Leuven
Leuven, 3000
Not yet recruiting
Centre Hospitalier Universitaire de Liege
Liège, 4000
Not yet recruiting
CHU UCL Namur
Namur, 5000
Not yet recruiting

Other trials in Belgium

Switzerland6 sites, 6 recruiting

University of Basel
Basel, 4031
Not yet recruiting
Inselspital - University Hospital Bern
Bern, 3010
Not yet recruiting
Hôpitaux Universitaires de Genève - HUG
Geneva, 1205
Not yet recruiting
CHUV, Lausanne University Hospital
Lausanne, 1005
Recruiting
University Hospital Zurich - Children's Hospital Zurich
Zurich, 8008
Not yet recruiting
University Hospital Zurich
Zurich, 8091
Not yet recruiting

Other trials in Switzerland

Austria4 sites, 4 recruiting

Medizinische Universität Graz
Graz, 8010
Not yet recruiting
Uniklinik Innsbruck
Innsbruck, 6020
Not yet recruiting
Allgemeines Krankenhaus Wien Universitätsklinik
Vienna, 1090
Not yet recruiting
Klinik Ottakring
Vienna, 1140
Not yet recruiting

Other trials in Austria

Saudi Arabia3 sites, 3 recruiting

King Faisal Specialist Hospital & Research Center
Jeddah, 66697
Not yet recruiting
King Faisal Specialist Hospital & Research Center
Riyadh, 11211
Not yet recruiting
King Fahad Medical City
Riyadh, 11525
Not yet recruiting

Other trials in Saudi Arabia

Australia2 sites, 2 recruiting

Nepean Hospital
Kingswood, 2747
Not yet recruiting
Princess Alexandra Hospital
Woolloongabba, 4102
Not yet recruiting

Other trials in Australia

Czechia2 sites, 2 recruiting

Institut klinicke a experimentalni mediciny
Prague, 14021
Not yet recruiting
Fakultni nemocnice v Motole
Prague, 16900
Not yet recruiting

Other trials in Czechia

Taiwan1 site, 1 recruiting

Taipei Veterans General Hospital
Taipei, 11217
Not yet recruiting

Other trials in Taiwan

About this study

Official title: Real-World Effectiveness and Safety of Pegcetacoplan in Patients With C3 Glomerulopathy (C3G) or Primary Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN): A Multi-Country Study

The purpose of this study is to evaluate the effectiveness and safety of Pegcetacoplan in patients with C3G and primary IC-MPGN in the real-world setting. This study will also assess biomarkers not routinely measured in clinical practice. Results will support the long-term evaluation of the benefit-risk profile of pegcetacoplan in a broad patient population, informing clinical decision-making.

Read the detailed description

The purpose of this study is to evaluate the effectiveness and safety of pegcetacoplan in patients with C3G and primary IC-MPGN in the real-world setting post-approval, as well as to characterise relevant biomarkers and their association with pegcetacoplan treatment. This will provide new information that was not evaluated in the clinical programme and help with understanding the long-term benefit-risk of pegcetacoplan in a broad patient population. This study will evaluate patient data prior to, during and after the use of pegcetacoplan to assess how the real-world use of pegcetacoplan impacts clinical outcomes and health care resource utilisation. This knowledge will contribute to informed clinical decision-making and provide guidance for effective disease management of patients with C3G or primary IC-MPGN.

Conditions: C3 Glomerulopathy (C3G), Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN)
Being tested: Pegcetacoplan
Keywords: C3 Glomerulopathy, Primary Immune Complex Membranoproliferative, Glomerulonephritis, Pegcetacoplan, Glomerulopathy, Nephrology, Rare disease
Medical subject headings: Glomerulonephritis, Rare Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PegcetacoplanDrug
Solution for infusion for subcutaneous use according to drug use in the real world.

Study groups in NCT07746895
Study group	Role	What they receive
Single arm	Other	Not described Receives: Drug: Pegcetacoplan

What is being measured

The primary outcome is the main question the study is designed to answer.

Achieving urine protein-to-creatinine ratio (UPCR) of <1 g/g
To describe the real-world clinical effectiveness of pegcetacoplan in participants with C3G or primary IC-MPGN
Measured: at 6 months after starting pegcetacoplan treatment

Secondary outcomes (33)

Participant demographics (age, sex, race)
To describe the demographics of participants initiating pegcetacoplan treatment.
Measured: Day 1 of treatment/Baseline.
Clinical characteristics of renal disease (UPCR)
To describe clinical characteristics (UPCR), of renal disease in participants initiating pegcetacoplan treatment.
Measured: Prior to and - Day 1 of treatment/Baseline.
Clinical characteristics of renal disease (eGFR)
To describe clinical characteristics (eGFR), of renal disease in participants initiating pegcetacoplan treatment.
Measured: Prior to and - Day 1 of treatment/Baseline.
Prior and concomitant C3G and primary IC-MPGN treatment information
To describe the medication use of participants initiating pegcetacoplan treatment.
Measured: Day 1 of treatment/Baseline.
≥50% proteinuria reduction
Cumulative incidence function will be used to describe the time from the start of pegcetacoplan treatment to the first occurrence of ≥50% proteinuria reduction.
Measured: At 1, 3, 6, 12 months and then every 6 months through the last dose received during the study, up to 5.5 years.
<1 g/g UPCR
Cumulative incidence function will be used to describe the time from the start of pegcetacoplan treatment to the first occurrence of <1 g/g UPCR.
Measured: At 1, 3, 6, 12 months and then every 6 months through the last dose received during the study, up to 5.5 years.
<0.5 g/g UPCR among participants aged 18 years or older
Cumulative incidence function will be used to describe the time from the start of pegcetacoplan treatment to the first occurrence of <0.5 g/g UPCR among participants aged 18 years or older.
Measured: At 1, 3, 6, 12 months and then every 6 months through the last dose received during the study, up to 5.5 years.
<0.2 g/g UPCR among participants less than 18 years of age
Cumulative incidence function will be used to describe the time from the start of pegcetacoplan treatment to the first occurrence of <0.2 g/g UPCR among participants less than 18 years of age.
Measured: Whenever the event occurs for the first time during pegcetacoplan treatment, up to 5.5 years.
Resolution of nephrotic syndrome in those with nephrotic syndrome
Cumulative incidence function will be used to describe the time from the start of pegcetacoplan treatment to the first occurrence of resolution of nephrotic syndrome in participants with nephrotic syndrome.
Measured: Whenever the event occurs for the first time during pegcetacoplan treatment, up to 5.5 years.
Sustained doubling of serum creatinine
Occurrence of sustained doubling of serum creatinine from baseline.
Measured: Whenever the event occurs for the first time during pegcetacoplan treatment, up to 5.5 years.
Progression to Chronic Kidney Disease Stage 5 or ESRD
Occurrence of Progression to Chronic Kidney Disease Stage 5 or ESRD from baseline.
Measured: At occurrence, prior to and during pegcetacoplan treatment, up to 5.5 years.
Receipt of new kidney transplant
Occurrence of receipt of new kidney transplant from baseline.
Measured: At occurrence, prior to and during pegcetacoplan treatment, up to 5.5 years.
New onset of maintenance dialysis (i.e., for at least 4 weeks)
Occurrence of new onset of maintenance dialysis (i.e., for at least 4 weeks)
Measured: At occurrence, prior to and during pegcetacoplan treatment, up to 5.5 years.
Death from kidney failure
Occurrence of death from kidney failure.
Measured: At occurrence, prior to and during pegcetacoplan treatment, up to 5.5 years.
Change in urine protein-to-creatinine ratio (UPCR) from the most recent diagnostic test results
Occurrence of change in UPCR from the most recent diagnostic test results.
Measured: Prior to start of pegcetacoplan treatment, at 1, 3, 6, 12 months, and then every 6 months through the last pegcetacoplan dose or up to 2 years after the enrolment date of the last participant.
Achieving UPCR of <1 g/g
Occurrence of UPCR of <1 g/g
Measured: At 1, 3, 6, 12 months and then every 6 months through the last pegcetacoplan dose or up to 2 years after the enrolment date of the last participant.
Change in eGFR derived from the most recent diagnostic test results of creatinine and height (if applicable)
Change in eGFR derived at 1, 3, 6, 12 months and then yearly from the most recent diagnostic test results of creatinine prior to start of pegcetacoplan.
Measured: Prior to start of pegcetacoplan treatment to eGFR derived at 1, 3, 6, 12 months and then until the last pegcetacoplan dose or up to 2 years after the enrolment date of the last participant.
Proportion of participants with annualised eGFR decline ≤5 mL/min/1.73 m2
Proportion of participants with annualised eGFR decline ≤5 mL/min/1.73 m2 yearly during pegcetacoplan treatment in the study.
Measured: Yearly during pegcetacoplan treatment up to the last pegcetacoplan dose or up to 2 years after the enrolment date of the last participant.
Change in kidney biopsy findings
Kidney biopsy findings through the last dose of pegcetacoplan received during the study.
Measured: At occurrence, during pegcetacoplan treatment, through the last pegcetacoplan dose or up to 2 years after the enrolment date of the last participant.
Summary of pegcetacoplan treatment information
To describe pegcetacoplan dosing schedule and treatment patterns.
Measured: Throughout the whole study duration whenever pegcetacoplan is administered per standard of care, up to 5.5 years.
Exposure-adjusted incidence rate of SAEs
Exposure-adjusted incidence rate of SAEs.
Measured: Ongoing from the start of pegcetacoplan treatment to study end, or 8 weeks post last dose of pegcetacoplan, whichever occurs earlier.
Exposure-adjusted incidence rate of AESIs
Exposure-adjusted incidence rate of AESIs
Measured: Ongoing from the start of pegcetacoplan treatment to study end, or 8 weeks post last dose of pegcetacoplan, whichever occurs earlier.
Summary scores of FACIT-Fatigue and WPAI
Summary scores of FACIT-Fatigue and WPAI
Measured: At the start of pegcetacoplan treatment, as available; at study enrolment; and every 6 months during treatment, through the last pegcetacoplan dose or up to 2 years after the enrolment date of the last participant.
Summary of TSQM among adult participants
Summary of TSQM among adult participants
Measured: At the start of pegcetacoplan treatment, as available, at study enrolment, and every 6 months during treatment through the last pegcetacoplan dose or up to 2 years after the enrolment date of the last participant.
Annualised number of C3G and primary IC-MPGN-related inpatient or outpatient hospital visits
Annualised C3G and primary IC-MPGN-related inpatient or outpatient hospital visits before, during and after treatment with pegectacoplan.
Measured: Prior to, during treatment and after the last pegcetacoplan dose or up to 2 years after the enrolment date of the last participant.
Annualised C3G-related length of hospital stays
Annualised C3G-related length of hospital stays before, during and after treatment with pegectacoplan.
Measured: Prior to, during treatment and after the last pegcetacoplan dose or up to 2 years after the enrolment date of the last participant.
Annualised primary IC-MPGN-related length of hospital stays
Annualised primary IC-MPGN-related length of hospital stays before, during and after pegcetacoplan treatment.
Measured: Prior to, during treatment and after the last pegcetacoplan dose or up to 2 years after the enrolment date of the last participant.
Annualised number of C3G-related length of ICU admissions
Annualised number of C3G-related ICU admissions before, during and after pegcetacoplan treatment.
Measured: Prior to, during treatment and after the last pegcetacoplan dose or up to 2 years after the enrolment date of the last participant.
Annualised number of primary IC-MPGN-related ICU admissions
Annualised number of primary IC-MPGN-related ICU admissions before, during and after pegcetacoplan treatment.
Measured: Prior to, during treatment and after the last pegcetacoplan dose or up to 2 years after the enrolment date of the last participant.
Annualised C3G-related length of ICU stay
Annualised C3G-related length of ICU stay before, during and after pegcetacoplan treatment.
Measured: Prior to, during treatment and after the last pegcetacoplan dose or up to 2 years after the enrolment date of the last participant.
Annualised primary IC-MPGN-related length of ICU stay
Annualised primary IC-MPGN-related length of ICU stay before, during and after pegcetacoplan treatment.
Measured: Prior to, during treatment and after the last pegcetacoplan dose or up to 2 years after the enrolment date of the last participant.
Annualised number of C3G-related emergency department visits
Annualised number of C3G-related emergency department visits before, during and after pegcetacoplan treatment.
Measured: Prior to, during treatment and after the last pegcetacoplan dose or up to 2 years after the enrolment date of the last participant.
Annualised number of primary IC-MPGN-related emergency department visits
Annualised number of primary IC-MPGN-related emergency department visits before, during and after pegcetacoplan treatment.
Measured: Prior to, during treatment and after the last pegcetacoplan dose or up to 2 years after the enrolment date of the last participant.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Aug 202631 Jan 2032

First posted5 Aug 2026
Study start5 Aug 2026
Primary completion31 Dec 2031 (estimated)
Study completion31 Jan 2032 (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)Studies of the same condition, open and under way.
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 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 150 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07746895
Sponsor's protocol ID: Sobi.PEGCET-402
Other IDs: 2025-524487-37-00, 2025
Status last verified: Sep 2026
First submitted: 26 Mar 2026
Last updated: 9 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

Study Physician

+46 86972000

medical.info@sobi.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

RecruitingPhase 3
Study of Efficacy and Safety of Iptacopan in Patients With C3 Glomerulopathy.
C3G
Not yet recruitingPhase 3
A Study to Assess the Efficacy and Safety of Pegcetacoplan for the Prevention of Recurrent C3G or Primary IC-MPGN in Kidney Transplant Recipients
C3 Glomerulopathy (C3G), Primary Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN), Recurrent Glomerular Disease After Kidney Transplantation
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 1
A Clinical Trial to Test the Safety, Tolerability, and How the Body Processes CPV-104 in Healthy People and Patients With C3-Glomerulopathy
C3 Glomerulopathy (C3G), Healthy Adult Participants
RecruitingPhase 2
A Phase 2 Study to Evaluate the Safety, PD, PK, and Clinical Activity of ADX-097 in Participants With IgAN, LN or C3G
IgA Nephropathy, Lupus Nephritis (LN)

All C3 Glomerulopathy (C3G) trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Real-World Effectiveness and Safety of Pegcetacoplan in Patients With C3 Glomerulopathy (C3G) or Primary Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN): A Multi-Country Study
ClinicalTrials.gov ID: NCT07746895
Acronym / sponsor ID: Sobi.PEGCET-402
Conditions: C3 Glomerulopathy (C3G), Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN)
Keywords: C3 Glomerulopathy, Primary Immune Complex Membranoproliferative, Glomerulonephritis, Pegcetacoplan, Glomerulopathy, Nephrology, Rare disease
Phase: Phase 4
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 150 participants (estimated)
Lead sponsor: Swedish Orphan BiovitrumIndustry (pharma, biotech, devices)
Collaborators: IQVIA Pty Ltd
Study start: 5 Aug 2026 (actual)
Primary completion: 31 Dec 2031 (estimated)
Study completion: 31 Jan 2032 (estimated)
First posted: 5 Aug 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Single arm	Other	Drug: Pegcetacoplan

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (2 listed)

Have received or plan to receive pegcetacoplan for the treatment of C3G or primary IC-MPGN.
Provided signed and dated informed consent. For participants under the legal age signed and dated informed consent is provided by the participant's legally authorised representative. Assent will also be obtained from paediatric participants as required by local regulations.

Key exclusion criteria (2 listed)

Receiving an investigational treatment for C3G or primary IC-MPGN at the time of pegcetacoplan initiation.
Initiated treatment with pegcetacoplan in an interventional study.

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
PegcetacoplanSolution for infusion for subcutaneous use according to drug use in the real world.	Drug	Single arm

Primary outcome

Achieving urine protein-to-creatinine ratio (UPCR) of <1 g/g
Time frame: at 6 months after starting pegcetacoplan treatment
To describe the real-world clinical effectiveness of pegcetacoplan in participants with C3G or primary IC-MPGN

33 secondary outcomes

Participant demographics (age, sex, race)
Time frame: Day 1 of treatment/Baseline.
Clinical characteristics of renal disease (UPCR)
Time frame: Prior to and - Day 1 of treatment/Baseline.
Clinical characteristics of renal disease (eGFR)
Time frame: Prior to and - Day 1 of treatment/Baseline.
Prior and concomitant C3G and primary IC-MPGN treatment information
Time frame: Day 1 of treatment/Baseline.
≥50% proteinuria reduction
Time frame: At 1, 3, 6, 12 months and then every 6 months through the last dose received during the study, up to 5.5 years.
<1 g/g UPCR
Time frame: At 1, 3, 6, 12 months and then every 6 months through the last dose received during the study, up to 5.5 years.
<0.5 g/g UPCR among participants aged 18 years or older
Time frame: At 1, 3, 6, 12 months and then every 6 months through the last dose received during the study, up to 5.5 years.
<0.2 g/g UPCR among participants less than 18 years of age
Time frame: Whenever the event occurs for the first time during pegcetacoplan treatment, up to 5.5 years.
Resolution of nephrotic syndrome in those with nephrotic syndrome
Time frame: Whenever the event occurs for the first time during pegcetacoplan treatment, up to 5.5 years.
Sustained doubling of serum creatinine
Time frame: Whenever the event occurs for the first time during pegcetacoplan treatment, up to 5.5 years.
Progression to Chronic Kidney Disease Stage 5 or ESRD
Time frame: At occurrence, prior to and during pegcetacoplan treatment, up to 5.5 years.
Receipt of new kidney transplant
Time frame: At occurrence, prior to and during pegcetacoplan treatment, up to 5.5 years.
New onset of maintenance dialysis (i.e., for at least 4 weeks)
Time frame: At occurrence, prior to and during pegcetacoplan treatment, up to 5.5 years.
Death from kidney failure
Time frame: At occurrence, prior to and during pegcetacoplan treatment, up to 5.5 years.
Change in urine protein-to-creatinine ratio (UPCR) from the most recent diagnostic test results
Time frame: Prior to start of pegcetacoplan treatment, at 1, 3, 6, 12 months, and then every 6 months through the last pegcetacoplan dose or up to 2 years after the enrolment date of the last participant.
Achieving UPCR of <1 g/g
Time frame: At 1, 3, 6, 12 months and then every 6 months through the last pegcetacoplan dose or up to 2 years after the enrolment date of the last participant.
Change in eGFR derived from the most recent diagnostic test results of creatinine and height (if applicable)
Time frame: Prior to start of pegcetacoplan treatment to eGFR derived at 1, 3, 6, 12 months and then until the last pegcetacoplan dose or up to 2 years after the enrolment date of the last participant.
Proportion of participants with annualised eGFR decline ≤5 mL/min/1.73 m2
Time frame: Yearly during pegcetacoplan treatment up to the last pegcetacoplan dose or up to 2 years after the enrolment date of the last participant.
Change in kidney biopsy findings
Time frame: At occurrence, during pegcetacoplan treatment, through the last pegcetacoplan dose or up to 2 years after the enrolment date of the last participant.
Summary of pegcetacoplan treatment information
Time frame: Throughout the whole study duration whenever pegcetacoplan is administered per standard of care, up to 5.5 years.
Exposure-adjusted incidence rate of SAEs
Time frame: Ongoing from the start of pegcetacoplan treatment to study end, or 8 weeks post last dose of pegcetacoplan, whichever occurs earlier.
Exposure-adjusted incidence rate of AESIs
Time frame: Ongoing from the start of pegcetacoplan treatment to study end, or 8 weeks post last dose of pegcetacoplan, whichever occurs earlier.
Summary scores of FACIT-Fatigue and WPAI
Time frame: At the start of pegcetacoplan treatment, as available; at study enrolment; and every 6 months during treatment, through the last pegcetacoplan dose or up to 2 years after the enrolment date of the last participant.
Summary of TSQM among adult participants
Time frame: At the start of pegcetacoplan treatment, as available, at study enrolment, and every 6 months during treatment through the last pegcetacoplan dose or up to 2 years after the enrolment date of the last participant.
Annualised number of C3G and primary IC-MPGN-related inpatient or outpatient hospital visits
Time frame: Prior to, during treatment and after the last pegcetacoplan dose or up to 2 years after the enrolment date of the last participant.
Annualised C3G-related length of hospital stays
Time frame: Prior to, during treatment and after the last pegcetacoplan dose or up to 2 years after the enrolment date of the last participant.
Annualised primary IC-MPGN-related length of hospital stays
Time frame: Prior to, during treatment and after the last pegcetacoplan dose or up to 2 years after the enrolment date of the last participant.
Annualised number of C3G-related length of ICU admissions
Time frame: Prior to, during treatment and after the last pegcetacoplan dose or up to 2 years after the enrolment date of the last participant.
Annualised number of primary IC-MPGN-related ICU admissions
Time frame: Prior to, during treatment and after the last pegcetacoplan dose or up to 2 years after the enrolment date of the last participant.
Annualised C3G-related length of ICU stay
Time frame: Prior to, during treatment and after the last pegcetacoplan dose or up to 2 years after the enrolment date of the last participant.
Annualised primary IC-MPGN-related length of ICU stay
Time frame: Prior to, during treatment and after the last pegcetacoplan dose or up to 2 years after the enrolment date of the last participant.
Annualised number of C3G-related emergency department visits
Time frame: Prior to, during treatment and after the last pegcetacoplan dose or up to 2 years after the enrolment date of the last participant.
Annualised number of primary IC-MPGN-related emergency department visits
Time frame: Prior to, during treatment and after the last pegcetacoplan dose or up to 2 years after the enrolment date of the last participant.

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 9 Sep 2026.

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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 contact

+46 86972000

medical.info@sobi.com

101 sites in 14 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 101 sites in Germany, France, Spain, United Kingdom, Italy and 9 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Achieving urine protein-to-creatinine ratio (UPCR) of <1 g/g (time frame: at 6 months after starting pegcetacoplan treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07746895.

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 9 Sep 2026.