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Monoclonal Antibodies

ARGX-117 for Delayed Graft Function (VARVARA Trial)

Phase 2
Recruiting
Research Sponsored by argenx
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 52 weeks

Summary

This trial is looking at how safe and effective a drug called ARGX-117 is in kidney transplant patients who are at risk for delayed graft function.

Who is the study for?
This trial is for deceased donor kidney transplant recipients aged 18-70, at risk for delayed graft function. Participants must have been on stable dialysis for 3+ months, weigh less than 120 kg with a BMI under 40, and agree to use contraception. They should be getting their first or second kidney transplant and have had necessary vaccinations including SARS-CoV-2.
What is being tested?
The study tests ARGX-117's safety and effectiveness in preventing delayed graft function after a kidney transplant from a deceased donor. It's a phase 2 trial where participants are randomly given either ARGX-117 or a placebo to compare outcomes.
What are the potential side effects?
Potential side effects of ARGX-117 aren't specified here but may include typical drug reactions such as allergic responses, site injection issues, general discomforts like headaches or nausea, and possibly immune system-related effects.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 52 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
eGFR at 24 weeks posttransplant
Secondary study objectives
CRR at 72 hours posttransplant and on study day 8
eGFR at 52 weeks posttransplant

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ARGX-117Experimental Treatment1 Intervention
Patients receiving ARGX-117 intravenous infusions
Group II: PlaceboPlacebo Group1 Intervention
Patients receiving placebo intravenous infusions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ARGX-117
2020
Completed Phase 2
~170

Find a Location

Who is running the clinical trial?

argenxLead Sponsor
72 Previous Clinical Trials
11,014 Total Patients Enrolled
~61 spots leftby Apr 2026
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