An Open-Label, Randomized, Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of Pegcetacoplan in the Treatment of Post-Transplant Recurrence of C3G or IC‑MPGN

Conditions

complement 3 glomerulopathy (C3G)/immune complex membranoproliferative glomerulonephritis (IC-MPGN)

Brief summary

The primary efficacy endpoint is the proportion of subjects with reduction in C3c staining on renal biopsy after 12 weeks of treatment with pegcetacoplan.

Detailed description

The proportion of subjects with reduction in C3c staining on renal biopsy after 52 weeks of treatment, The proportion of subjects with stabilization or improvement in estimated glomerular filtration rate (eGFR), over time, The proportion of subjects with stabilization or improvement of serum creatinine concentration over time, Changes from baseline biopsy in C3c staining over time, Changes and percentage changes from baseline in eGFR and serum creatinine concentration over time, Safety: The number and incidence of treatment-emergent adverse events (TEAEs), Safety: The change from baseline in vital signs measurements and clinical laboratory test and ECG results

Related papers

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Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGASPAVELI 1 080 mg solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary efficacy endpoint is the proportion of subjects with reduction in C3c staining on renal biopsy after 12 weeks of treatment with pegcetacoplan.	—

Secondary

Measure	Time frame
The proportion of subjects with reduction in C3c staining on renal biopsy after 52 weeks of treatment, The proportion of subjects with stabilization or improvement in estimated glomerular filtration rate (eGFR), over time, The proportion of subjects with stabilization or improvement of serum creatinine concentration over time, Changes from baseline biopsy in C3c staining over time, Changes and percentage changes from baseline in eGFR and serum creatinine concentration over time, Safety: The number and incidence of treatment-emergent adverse events (TEAEs), Safety: The change from baseline in vital signs measurements and clinical laboratory test and ECG results	—

Measure

Time frame

The proportion of subjects with reduction in C3c staining on renal biopsy after 52 weeks of treatment, The proportion of subjects with stabilization or improvement in estimated glomerular filtration rate (eGFR), over time, The proportion of subjects with stabilization or improvement of serum creatinine concentration over time, Changes from baseline biopsy in C3c staining over time, Changes and percentage changes from baseline in eGFR and serum creatinine concentration over time, Safety: The number and incidence of treatment-emergent adverse events (TEAEs), Safety: The change from baseline in vital signs measurements and clinical laboratory test and ECG results

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Countries

Austria, Italy, Netherlands

Outcome results

None listed