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A 2-year, single-arm, multi-center study to explore the efficacy and safety of pegcetacoplan in preventing disease recurrence in adolescent and adult kidney transplant recipients with C3 glomerulopathy or primary immune-complex membranoproliferative glomerulonephritis

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2026-526392-39-00
Enrollment
13
Registered
2026-10-20
Start date
Unknown
Completion date
Unknown
Last updated
2026-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Male or female patients with a diagnosis of C3G or primary IC˗MPGN and planning to undergo kidney transplantation because of the disease.

Brief summary

Occurrence of clinically significant recurrent disease within 2 years post–kidney transplantation, defined by both histological evidence from the biopsy and clinical evidence of recurrence (≥1 of the following: increase in urinary protein-to-creatinine ratio, decrease in eGFR, or hematuria), judged clinically significant by the Investigator in the absence of alternative causes

Detailed description

Time from kidney transplantation surgery to onset of clinically significant recurrence of C3G or primary IC-MPGN, Histological evidence of recurrent disease within 2 years of kidney transplantation, based on the histopathological assessment of a kidney biopsy at the study center, Time from kidney transplantation surgery to histological evidence of recurrent disease, The incidence of serious adverse events (SAEs) and adverse events of special interest (AESIs)

Interventions

Sponsors

Swedish Orphan Biovitrum AB (publ)
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Occurrence of clinically significant recurrent disease within 2 years post–kidney transplantation, defined by both histological evidence from the biopsy and clinical evidence of recurrence (≥1 of the following: increase in urinary protein-to-creatinine ratio, decrease in eGFR, or hematuria), judged clinically significant by the Investigator in the absence of alternative causes—

Secondary

MeasureTime frame
Time from kidney transplantation surgery to onset of clinically significant recurrence of C3G or primary IC-MPGN, Histological evidence of recurrent disease within 2 years of kidney transplantation, based on the histopathological assessment of a kidney biopsy at the study center, Time from kidney transplantation surgery to histological evidence of recurrent disease, The incidence of serious adverse events (SAEs) and adverse events of special interest (AESIs)—

Outcome results

None listed

Source: EU CTIS · Data processed: Oct 22, 2026