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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Solution for infusion for subcutaneous use according to drug use in the real world.
Nepean Hospital
Kingswood, Australia
NOT_YET_RECRUITINGPrincess Alexandra Hospital
Woolloongabba, Australia
NOT_YET_RECRUITINGMedizinische Universität Graz
Graz, Austria
NOT_YET_RECRUITINGUniklinik Innsbruck
Innsbruck, Austria
NOT_YET_RECRUITINGAchieving 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Allgemeines Krankenhaus Wien Universitätsklinik
Vienna, Austria
NOT_YET_RECRUITINGKlinik Ottakring
Vienna, Austria
NOT_YET_RECRUITINGCliniques Universitaires Saint-Luc
Brussels, Belgium
NOT_YET_RECRUITINGUniversity hosptial of Antwerpen
Edegem, Belgium
NOT_YET_RECRUITINGGrand Hôpital de Charleroi
Gilly, Belgium
NOT_YET_RECRUITINGUZ Leuven
Leuven, Belgium
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