A Global, Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Phase 2 Study to Evaluate the Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC Administered by a Prefilled Syringe in Kidney Transplant Recipients with Antibody Mediated Rejection.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-508180-72-00

Acronym

ARGX-113-2302

Enrollment

Registered

2024-10-14

Start date

2024-12-11

Completion date

Unknown

Last updated

2025-12-10

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

Conditions

Antibody-Mediated Rejection

Brief summary

Incidence and severity of Adverse Events (AEs), Percentage of participants with permanent treatment discontinuation due to AEs, Laboratory assessments, vital sign measurements, and ECG

Detailed description

eGFR (absolute values and changes from baseline [slope]), Histologic changes in kidney biopsy, Urine Protein Creatinine Ratio, Graft and participant survival, Percentage change from baseline in total IgG levels in serum over time, Efgartigimod serum concentration over time and PK parameter Ctrough, Incidence and prevalence of antidrug antibody(ies) (ADA) against efgartigimod in serum over time, Incidence and prevalence of antibodies against rHuPH20 in plasma over time

Interventions

DRUGPlacebo PH20 SC – prefilled syringe (placebo to Efgartigimod PH20 SC – prefilled syringe)

DRUGEfgartigimod

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Incidence and severity of Adverse Events (AEs), Percentage of participants with permanent treatment discontinuation due to AEs, Laboratory assessments, vital sign measurements, and ECG	—

Secondary

Measure	Time frame
eGFR (absolute values and changes from baseline [slope]), Histologic changes in kidney biopsy, Urine Protein Creatinine Ratio, Graft and participant survival, Percentage change from baseline in total IgG levels in serum over time, Efgartigimod serum concentration over time and PK parameter Ctrough, Incidence and prevalence of antidrug antibody(ies) (ADA) against efgartigimod in serum over time, Incidence and prevalence of antibodies against rHuPH20 in plasma over time	—

Measure

Time frame

—

Countries

Austria, Belgium, Czechia, France, Germany, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026