ARGX-117 for Delayed Graft Function

(VARVARA Trial)

Not currently recruiting at 53 trial locations

Overseen By Sabine s Coppieters, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: argenx

Disqualifiers: Prothrombotic disorder, Complement deficiency, Infection, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called ARGX-117 (also known as Empasiprubart) for individuals who have received a kidney transplant from a deceased donor and face the risk of delayed graft function, where the new kidney might not start working immediately. The study compares ARGX-117 to a placebo to assess its safety and effectiveness. Participants will receive treatment for up to a year, followed by a short monitoring period. This trial may suit those with end-stage kidney disease who have been on dialysis for at least three months and have recently received a compatible kidney transplant. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that ARGX-117 is likely to be safe for humans?

Research has shown that ARGX-117, also known as empasiprubart, was safe in earlier studies. Most patients tolerated ARGX-117 well, and studies with both single and multiple doses found no major safety issues. While these results are promising, more research is needed to fully confirm its safety in humans. For those considering joining a trial, this means ARGX-117 has been fairly safe in past research, but scientists continue to gather more information. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for delayed graft function?

Researchers are excited about ARGX-117 because it offers a new approach to treating delayed graft function. Unlike the standard treatments that typically focus on managing symptoms with anti-inflammatory drugs and other supportive care, ARGX-117 is an antibody designed to target and inhibit the complement system, which plays a key role in inflammation and tissue damage following a transplant. By directly interfering with this mechanism, ARGX-117 has the potential to reduce the severity of delayed graft function more effectively than current options, paving the way for better outcomes in transplant patients.

What evidence suggests that ARGX-117 might be an effective treatment for delayed graft function?

Research has shown that ARGX-117, also known as empasiprubart, may improve kidney function in individuals with delayed recovery after a kidney transplant. In this trial, some participants will receive ARGX-117, while others will receive a placebo. Studies found that patients who received ARGX-117 showed better results than those who received a placebo, with improvements in key health measures. Early findings suggest that ARGX-117 helps by modulating the immune system, potentially protecting the new kidney. While more information is needed, these early results offer promise for those at risk of delayed recovery. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Is capable of providing signed informed consent and complying with protocol requirements

Agree to use contraceptive measures consistent with local regulations

Are ABO compatible with donor allograft, except for type A2 donor to type B recipient kidneys

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment and Evaluation

Participants receive either ARGX-117 or placebo for up to 52 weeks to assess safety, efficacy, and tolerability

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Long-term Observational Follow-up

Participants may enroll in a long-term follow-up period to monitor allograft function post-transplant

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• ARGX-117

Trial Overview 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.

How Is the Trial Designed?

Group I: ARGX-117 Experimental Treatment 1 Intervention

Patients receiving ARGX-117 intravenous infusions

Group II: Placebo Placebo Group 1 Intervention

Patients receiving placebo intravenous infusions

Who Is Running the Clinical Trial?

argenx

Lead Sponsor

Trials

76

Recruited

11,500+

Tim Van Hauwermeiren

argenx

Chief Executive Officer since 2008

B.Sc. and M.Sc. in Bioengineering from Ghent University, Executive MBA from The Vlerick School of Management

Dr. Peter Ulrichts

argenx

Chief Medical Officer since 2023

MD from Maastricht University, PhD in Molecular Immunology from Maastricht University

Citations

1. clinicaltrials.eu clinicaltrials.eu/trial/study-on-argx-117-for-improving-kidney-function-in-patients-with-delayed-graft-function-after-deceased-donor-transplant/

Study on ARGX-117 for Improving Kidney Function in ... This clinical trial investigates the efficacy of ARGX-117 in improving kidney function in patients experiencing delayed graft function ...

2. argenx.com argenx.com/news/2023/argenx-initiates-second-cohort-phase-2-arda-study-empasiprubart-multifocal-motor-neuropathy

argenx Initiates Second Cohort of Phase 2 ARDA Study ... The data showed distinct separation between treated patients and placebo based on a suite of clinical outcome measures, including time to IVIg ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05907096

NCT05907096 | ARGX-117 in Deceased Donor Kidney ... 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 ...

4. nature.com nature.com/articles/s41467-025-62925-1

Randomized phase I trial outcomes show safe and ... Single and multiple ascending doses of empasiprubart are generally safe and well tolerated. Overall, our results reveal in atomic detail the ...

5. amjtransplant.org amjtransplant.org/article/S1600-6135(25)01875-1/fulltext

Empasiprubart in Improving Allograft Function ... Results: The primary objective is to evaluate the efficacy of empasiprubart versus placebo in improving allograft function in deceased donor kidney transplants ...