A Study to Test How Kidney Problems Influence the Blood Concentrations of Efgartigimod

Sponsor
argenx
Study ID
NCT05927415
Phase
PHASE1
Status
Completed

Conditions

  • Renal Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Efgartigimod IV — BIOLOGICAL
    Intravenous infusion of efgartigimod

Study Details

A study to test how kidney problems influence the blood concentrations of efgartigimod

Key Dates

First listed
Jul 3, 2023
Start date
Jul 17, 2023
Status verified
Jun 2024
Primary completion
Jun 12, 2024
Completion
Jun 12, 2024

Study Design

Enrollment
33 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Mild renal impairment
    Patients with 60 \<= eGFR \<90
  • Experimental: Moderate renal impairment
    Patients with 30 \<= eGFR \<60
  • Experimental: Severe renal impairment
    Patients with eGFR \<30
  • Experimental: Normal renal function
    Patients with eGFR \>=90

Primary Outcome Measure

Efgartigimod PK parameters (Cmax) [ Time Frame: up to 64 days ]

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