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NCT Number: NCT07746895

Real-World Effectiveness and Safety of Pegcetacoplan in Patients With C3G or IC-MPG: 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.

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Key information

Conditions

C3 Glomerulopathy (C3G) Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glomerulonephritis Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN) Kidney Diseases Male Urogenital Diseases Nephritis Pathologic Processes Pathological Conditions, Signs and Symptoms Rare Diseases Urogenital Diseases Urologic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Nepean Hospital, Kingswood, Australia

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About this 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 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Pegcetacoplan

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Participant demographics (age, sex, race)

    Time frame: Day 1 of treatment/Baseline.

    To describe the demographics of participants initiating pegcetacoplan treatment.

  2. Clinical characteristics of renal disease (UPCR)

    Time frame: Prior to and - Day 1 of treatment/Baseline.

    To describe clinical characteristics (UPCR), of renal disease in participants initiating pegcetacoplan treatment.

  3. Clinical characteristics of renal disease (eGFR)

    Time frame: Prior to and - Day 1 of treatment/Baseline.

    To describe clinical characteristics (eGFR), of renal disease in participants initiating pegcetacoplan treatment.

  4. Prior and concomitant C3G and primary IC-MPGN treatment information

    Time frame: Day 1 of treatment/Baseline.

    To describe the medication use of participants initiating pegcetacoplan treatment.

  5. ≥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.

    Cumulative incidence function will be used to describe the time from the start of pegcetacoplan treatment to the first occurrence of ≥50% proteinuria reduction.

  6. <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.

    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.

  7. <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.

    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.

  8. <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.

    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.

  9. 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.

    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.

  10. Sustained doubling of serum creatinine

    Time frame: Whenever the event occurs for the first time during pegcetacoplan treatment, up to 5.5 years.

    Occurrence of sustained doubling of serum creatinine from baseline.

  11. Progression to Chronic Kidney Disease Stage 5 or ESRD

    Time frame: At occurrence, prior to and during pegcetacoplan treatment, up to 5.5 years.

    Occurrence of Progression to Chronic Kidney Disease Stage 5 or ESRD from baseline.

  12. Receipt of new kidney transplant

    Time frame: At occurrence, prior to and during pegcetacoplan treatment, up to 5.5 years.

    Occurrence of receipt of new kidney transplant from baseline.

  13. 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.

    Occurrence of new onset of maintenance dialysis (i.e., for at least 4 weeks)

  14. Death from kidney failure

    Time frame: At occurrence, prior to and during pegcetacoplan treatment, up to 5.5 years.

    Occurrence of death from kidney failure.

  15. 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.

    Occurrence of change in UPCR from the most recent diagnostic test results.

  16. 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.

    Occurrence of UPCR of <1 g/g

  17. 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.

    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.

  18. 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.

    Proportion of participants with annualised eGFR decline ≤5 mL/min/1.73 m2 yearly during pegcetacoplan treatment in the study.

  19. 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.

    Kidney biopsy findings through the last dose of pegcetacoplan received during the study.

  20. 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.

    To describe pegcetacoplan dosing schedule and treatment patterns.

  21. 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 SAEs.

  22. 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.

    Exposure-adjusted incidence rate of AESIs

  23. 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 scores of FACIT-Fatigue and WPAI

  24. 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.

    Summary of TSQM among adult participants

  25. 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 and primary IC-MPGN-related inpatient or outpatient hospital visits before, during and after treatment with pegectacoplan.

  26. 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 C3G-related length of hospital stays before, during and after treatment with pegectacoplan.

  27. 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 primary IC-MPGN-related length of hospital stays before, during and after pegcetacoplan treatment.

  28. 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 C3G-related ICU admissions before, during and after pegcetacoplan treatment.

  29. 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 number of primary IC-MPGN-related ICU admissions before, during and after pegcetacoplan treatment.

  30. 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 C3G-related length of ICU stay before, during and after pegcetacoplan treatment.

  31. 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 primary IC-MPGN-related length of ICU stay before, during and after pegcetacoplan treatment.

  32. 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 C3G-related emergency department visits before, during and after pegcetacoplan treatment.

  33. 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.

    Annualised number of primary IC-MPGN-related emergency department visits before, during and after pegcetacoplan treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Study Physician

CONTACT

[email protected]

+46 86972000

Sponsors and collaborators

Lead sponsor

Swedish Orphan Biovitrum

Industry

Collaborators

  • IQVIA Pty Ltd

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2031
Study completion
2032
First posted
Aug 5, 2026
Registry last updated
Aug 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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