An Open-Label, Nonrandomized, Multicenter Extension Study to Evaluate the Long-term Safety and Efficacy of Pegcetacoplan in Participants With C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis (VALE)

Conditions

C3 glomerulopathy (C3G) or immune complex membranoproliferative glomerulonephritis (IC-MPGN)

Brief summary

The log-transformed ratio of urine protein-to-creatinine ratio (uPCR) over time compared to pretreatment baseline.

Detailed description

The proportion of participants with estimated glomerular filtration rate (eGFR) values that are stable or improved from pretreatment values over time., The proportion of participants achieving proteinuria <1 g/day over time., Change from pretreatment in the Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-Fatigue) Scale score., Change from pretreatment in eGFR values over time., For participants with pretreatment serum albumin levels below the lower limit of normal (LLN), the proportion of participants with normalization of serum albumin levels over time, For participants with pretreatment serum C3 levels below the LLN, the proportion of participant s with normalization of serum C3 levels over time., The proportion of participants with progression to a clinical composite outcome (at least one of the following: doubling of serum creatinine, progression to chronic kidney disease stage 5 or ESRD, renal transplantation, or death) over time.

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Interventions

DRUGASPAVELI 1 080 mg solution for infusion

DRUGNimenrix powder and solvent for solution for injection in vials Meningococcal groups A

DRUGC

DRUGW-135 and Y conjugate vaccine

DRUGPNEUMOVAX 23 Solución inyectable en vial Vacuna antineumocócica de polisacáridos

DRUGPNEUMOVAX soluzione iniettabile in siringa preriempita Vaccino pneumococcico polisaccaridico

DRUGBexsero suspension for injection in pre-filled syringe Meningococcal group B Vaccine (rDNA

DRUGcomponent

DRUGadsorbed)

DRUGPneumovax 23 injekční roztok v předplněné injekční stříkačce pneumokoková polysacharidová vakcína

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The log-transformed ratio of urine protein-to-creatinine ratio (uPCR) over time compared to pretreatment baseline.	—

Secondary

Measure	Time frame
The proportion of participants with estimated glomerular filtration rate (eGFR) values that are stable or improved from pretreatment values over time., The proportion of participants achieving proteinuria <1 g/day over time., Change from pretreatment in the Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-Fatigue) Scale score., Change from pretreatment in eGFR values over time., For participants with pretreatment serum albumin levels below the lower limit of normal (LLN), the proportion of participants with normalization of serum albumin levels over time, For participants with pretreatment serum C3 levels below the LLN, the proportion of participant s with normalization of serum C3 levels over time., The proportion of participants with progression to a clinical composite outcome (at least one of the following: doubling of serum creatinine, progression to chronic kidney disease stage 5 or ESRD, renal transplantation, or death) over time.	—

Measure

Time frame

The proportion of participants with estimated glomerular filtration rate (eGFR) values that are stable or improved from pretreatment values over time., The proportion of participants achieving proteinuria <1 g/day over time., Change from pretreatment in the Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-Fatigue) Scale score., Change from pretreatment in eGFR values over time., For participants with pretreatment serum albumin levels below the lower limit of normal (LLN), the proportion of participants with normalization of serum albumin levels over time, For participants with pretreatment serum C3 levels below the LLN, the proportion of participant s with normalization of serum C3 levels over time., The proportion of participants with progression to a clinical composite outcome (at least one of the following: doubling of serum creatinine, progression to chronic kidney disease stage 5 or ESRD, renal transplantation, or death) over time.

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Countries

Austria, Belgium, Czechia, France, Germany, Italy, Netherlands, Spain

Outcome results

None listed