NCT05907096

ARGX-117 in Deceased Donor Kidney Transplant Recipients at Risk for Delayed Graft Function

A Phase 2, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study to Assess the Safety, Efficacy, and Tolerability of ARGX-117 in Improving Allograft Function in Recipients of a Deceased Donor Renal Allograft at Risk for Delayed Graft Function

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: argenx · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to evaluate the safety, efficacy and tolerability of ARGX-117 in Deceased Donor Kidney Transplant Recipients at Risk for Delayed Graft Function. The study consists of 2 parts: part A comprises the main study period, and part B comprises the long-term observational follow-up period. During part A, after the screening period, eligible participants will be randomized to receive either ARGX-117 or placebo, entering the treatment and evaluation period (duration of up to 52 weeks). After the treatment period, participants will enter a follow-up period of up to 12 weeks. The total study duration varies from approximately 64 weeks up to 5 years post-transplant depending on whether a participant enrols in part B of the study.

Conditions

• Delayed Graft Function

Interventions

Type	Name	Description
BIOLOGICAL	ARGX-117	Intravenous administration of ARGX-117
OTHER	Placebo	Intravenous administration of placebo

Timeline

• Start date: 2024-02-17
• Primary completion: 2025-10-16
• Completion: 2026-07-31
• First posted: 2023-06-18
• Last updated: 2026-03-18

Locations

45 sites across 11 countries: United States, Australia, Austria, Belgium, Brazil, Canada, France, Italy, Portugal, Spain, Sweden

Regulatory

• FDA-regulated drug study