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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

Awards & highlights

VARVARA Trial 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.Check my eligibility

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.See study design

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.

VARVARA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 52 weeks

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

eGFR at 24 weeks posttransplant

Secondary outcome measures

CRR at 72 hours and on study day 8 (posttransplant day 7)

Change from baseline in free C2, total C2, and CH50 activity

Dialysis-free survival through 52 weeks posttransplant

+9 more

VARVARA 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 1

~110

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

argenxLead Sponsor

60 Previous Clinical Trials

9,153 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the clinical trial open to participants younger than 75 years of age?

"Individuals aged between 18 and 70 years are eligible for participation in this trial."

Answered by AI

What are the safety considerations for patients receiving ARGX-117?

"Based on our evaluation at Power, the safety rating for ARGX-117 is graded as 2 due to it being in a Phase 2 trial; indicating some evidence supporting its safety profile but lacking data on efficacy."

Answered by AI

Are there currently any available slots for new participants in this medical trial?

"Indeed, the details on clinicaltrials.gov reveal that this study is currently enrolling subjects. Originally shared on February 17th, 2024, with the most recent update made on March 5th, 2024; a total of 102 participants are sought from six distinct sites."

Answered by AI

Are there multiple medical facilities in the area participating in this study?

"Six medical facilities are currently active in conducting this clinical trial, with participating centers including the Centro Hospitalar Universitario de Santo Antonio in Porto, the Royal Adelaide Hospital in Adelaide, and the Hôpital Maisonneuve-Rosemont - Centre de recherche in Montréal."

Answered by AI

Am I eligible to enroll in this clinical trial?

"Candidates eligible for participation in this trial must be of legal adult age, capable of providing informed consent, willing to adhere to the study's protocols, agree to use appropriate contraceptive methods as per local guidelines. They should also have a body weight under 120 kg and a BMI below 40 kg/m2 at screening. Additionally, they must have end-stage renal disease (ESRD) with a stable history on dialysis for over three months, received either their first or second deceased-donor kidney transplant from donors meeting specific criteria including ABO compatibility and negative cross-match results. Moreover, they need pretransplant vaccinations against certain pathogens or an intention"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "ARGX-117 in Deceased Donor Kidney Transplant Recipients at Risk for Delayed Graft Function". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05907096.

All > Kidney Transplant