A Phase 4 interventional study of Pegcetacoplan in C3 Glomerulopathy (C3G) and Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN), sponsored by Swedish Orphan Biovitrum. Recruiting at 101 sites in 14 countries. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Swedish Orphan Biovitrum · Phase 4, Interventional, and Treatment
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.
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.
115 studies on the registry are indexed under Glomerulonephritis; 32 are open to participants now.
This study's planned enrollment of 150 is above the median of 50 across 87 interventional studies indexed under Glomerulonephritis.
Browse Glomerulonephritis studies →Swedish Orphan Biovitrum is the lead sponsor of 82 studies on the registry; 6 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 15 (88%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Pegcetacoplan
Solution for infusion for subcutaneous use according to drug use in the real world.
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
Time frame: at 6 months after starting pegcetacoplan treatment
Participant demographics (age, sex, race)
To describe the demographics of participants initiating pegcetacoplan treatment.
Time frame: Day 1 of treatment/Baseline.
Clinical characteristics of renal disease (UPCR)
To describe clinical characteristics (UPCR), of renal disease in participants initiating pegcetacoplan treatment.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
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.
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
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.
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
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.
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
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.
Time frame: 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.
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
Occurrence of Progression to Chronic Kidney Disease Stage 5 or ESRD from baseline.
Time frame: 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.
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)
Occurrence of 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
Occurrence of 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
Occurrence of change in 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
Occurrence of 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)
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.
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
Proportion of participants with annualised eGFR decline ≤5 mL/min/1.73 m2 yearly during pegcetacoplan treatment in the study.
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
Kidney biopsy findings through the last dose of pegcetacoplan received during the study.
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
To describe pegcetacoplan dosing schedule and treatment patterns.
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
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
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
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
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
Annualised C3G and primary IC-MPGN-related inpatient or outpatient hospital visits before, during and after treatment with pegectacoplan.
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
Annualised C3G-related length of hospital stays before, during and after treatment with pegectacoplan.
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
Annualised primary IC-MPGN-related length of hospital stays before, during and after pegcetacoplan treatment.
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
Annualised number of C3G-related ICU admissions before, during and after pegcetacoplan treatment.
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
Annualised number of primary IC-MPGN-related ICU admissions before, during and after pegcetacoplan treatment.
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
Annualised C3G-related length of ICU stay before, during and after pegcetacoplan treatment.
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
Annualised primary IC-MPGN-related length of ICU stay before, during and after pegcetacoplan treatment.
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
Annualised number of C3G-related emergency department visits before, during and after pegcetacoplan treatment.
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
Annualised number of primary IC-MPGN-related emergency department visits before, during and after pegcetacoplan treatment.
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.
Showing the first 100 of 101 sites across 14 countries. Choose a country and city above to see the rest.
Started Aug 2026 (actual). Primary completion is estimated for Dec 2031, 64 months after the start.
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Studies of the drug tested here: Pegcetacoplan