ARGX-117 for Delayed Graft Function
(VARVARA Trial)

Recruiting in Palo Alto (17 mi)

+42 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: argenx

Disqualifiers: Prothrombotic disorder, Complement deficiency, Infection, others

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

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.

Eligibility Criteria

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

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

Have a negative cross match

I have had or am willing to get vaccinations for meningitis, pneumonia, and Haemophilus influenzae after my transplant.

+7 more

Trial Timeline

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

Participant Groups

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.

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