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PRESERVENCT07898774

A Study to Assess the Efficacy and Safety of Pegcetacoplan for the Prevention of Recurrent C3G or Primary IC-MPGN in Kidney Transplant Recipients

StatusRecruiting
PhasePhase 3
Primary completion (estimated)
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Record History

All 3 versions: 3 with changes below. See every version on ClinicalTrials.gov ↗

  1. Recruitment opened
    • Site details revised at 33 of 33 sites
  2. Eligibility criteria expanded, about 16 words Show 4 more changesShow less
    • Secondary endpoints: details revised at 1 of 1 entry
    • Site details revised at 1 of 33 sites
    • Study description shortened, about 1 word
    • Study title expanded, about 2 words
  3. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

Occurrence of Clinically Significant Recurrent Disease
Timeframe: Within 2 years after kidney transplantation

Secondary (1)

Time to Onset of Clinically Significant Disease Recurrence

Arms and interventions

PegcetacoplanExperimental

Pegcetacoplan, a complement C3/C3b inhibitor, administered according to the study protocol in kidney transplant recipients with high risk of recurring C3G or primary IC-MPGN

Drugs: Pegcetacoplan

Sites

33 sites in 10 countries

France 6, Canada 5, Spain 5, Italy 4, United Kingdom 4, Brazil 3, Germany 3, Finland 1, Saudi Arabia 1, Switzerland 1