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Study on ARGX-117 for Improving Kidney Function in Patients with Delayed Graft Function After Deceased Donor Transplant

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as delayed graft function, which can occur in patients who have received a kidney transplant from a deceased donor. This condition means that the new kidney may not start working as quickly as expected after the transplant. The study is testing a treatment called ARGX-117, which is given as an intravenous infusion, meaning it is administered directly into the bloodstream through a vein. The purpose of the study is to see if ARGX-117 can help improve the function of the transplanted kidney in patients who are at risk for delayed graft function.

Participants in the study will be randomly assigned to receive either ARGX-117 or a placebo, which looks like the treatment but does not contain the active substance. The study is designed to be double-blinded, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. This helps ensure that the results are not influenced by expectations about the treatment. The study will take place over several weeks, with regular check-ups to monitor the health and kidney function of the participants.

The main goal is to assess how well the transplanted kidney is working 24 weeks after the transplant. Other aspects being monitored include the number of participants who experience delayed graft function, the duration of any dialysis treatment needed, and overall safety outcomes. The study will also look at how the body processes ARGX-117 and any potential immune responses to the treatment. The results will help determine if ARGX-117 is a safe and effective option for improving kidney function in transplant recipients at risk for delayed graft function.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the participant will be randomly assigned to receive either the medication ARGX-117 or a placebo. This process is double-blinded, meaning neither the participant nor the study team will know which treatment is being administered.

  2. Step 2

    Medication administration

    The medication, ARGX-117, is administered as an intravenous infusion. This means it is given directly into a vein through a drip. The placebo is also given in the same manner to ensure consistency in the study.

  3. Step 3

    Monitoring and assessments

    Participants will undergo regular monitoring to assess the function of the transplanted kidney. This includes measuring the estimated glomerular filtration rate (eGFR) at 24 weeks after the transplant.

    Additional assessments will include monitoring for delayed graft function (DGF), the duration of any dialysis treatment required, and other safety outcomes such as adverse events.

  4. Step 4

    Follow-up evaluations

    Follow-up evaluations will continue up to 52 weeks post-transplant. These evaluations will include further measurements of eGFR, dialysis-free survival, and other health indicators.

    The study will also track the presence of any antibodies against ARGX-117 and other relevant biological markers.

  5. Step 5

    Completion of the study

    The study is expected to conclude by April 2026. At the end of the study, all collected data will be analyzed to determine the efficacy and safety of ARGX-117 in improving kidney transplant outcomes.

Who can join the trial?

10 criteria

  • Must be at least the local legal age of consent for clinical studies, at least 18 years old, and less than 70 years old when signing the informed consent form.
  • Must have received COVID-19 vaccinations as required by the study location.
  • Must be able to provide signed informed consent and follow the study's requirements.
  • Must agree to use birth control methods as required by local regulations.
  • Must have a dry body weight of less than 120 kg and a body mass index (BMI) of less than 40 kg/m² at the time of screening. BMI is a measure of body fat based on height and weight.
  • Must be diagnosed with **ESRD** (End-Stage Renal Disease) and have been stable on regular dialysis for at least 3 months. Dialysis is a treatment that does some of the things done by healthy kidneys.
  • Must be receiving a first-time or second-time single kidney transplant from a deceased donor. The donor can be either **DCD** (Donation after Circulatory Death) or **DBD** (Donation after Brain Death).
  • Must be **ABO compatible** with the donor kidney, except for type A2 donor to type B recipient kidneys. ABO compatibility refers to matching blood types between donor and recipient.
  • Must have a negative cross match. A cross match is a test to check if the recipient's body will accept the donor kidney.
  • Must have received vaccinations before the transplant for **Neisseria meningitidis**, **Streptococcus pneumoniae**, and **Haemophilus influenzae**, or be willing to receive these vaccinations about 3 to 4 months after the transplant. These are vaccines to protect against certain infections.

Who cannot join the trial?

8 criteria

  • Patients who have a history of severe allergic reactions to any of the study medications.
  • Patients who are currently participating in another clinical trial.
  • Patients with a known infection that is not well controlled.
  • Patients who have received an organ transplant other than a kidney.
  • Patients with a history of cancer that is not in remission.
  • Patients who are pregnant or breastfeeding.
  • Patients with a history of drug or alcohol abuse.
  • Patients with any other medical condition that the study doctors believe would make it unsafe for them to participate.
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Investigated drugs

ARGX-117 is a medication being studied to see if it can help improve the function of a transplanted kidney from a deceased donor. The trial is focused on patients who are at risk of experiencing delayed graft function, which means the new kidney might not start working as quickly as expected after the transplant. The study aims to determine if ARGX-117 can make the kidney work better and more quickly in these situations.

What is already known about the treatment

ARGX-117 – ARGX-117 is administered intravenously and is currently being studied in clinical trials for its potential to improve kidney function in patients who have received a kidney transplant from a deceased donor and are at risk for delayed graft function. This medication is in the investigational stage and is not yet approved for general medical use. It is being evaluated for its ability to enhance the function of transplanted kidneys by modulating the immune response. ARGX-117 is classified as an immunomodulatory agent, working at the molecular level to potentially reduce inflammation and improve graft acceptance.

Investigated diseases

Delayed Graft Function – Delayed graft function is a condition that occurs after a kidney transplant, where the transplanted kidney does not start working immediately. This condition is often characterized by the need for dialysis within the first week after the transplant. It is more common in kidneys from deceased donors and can be influenced by factors such as the health of the donor kidney and the recipient's condition. The delayed function can lead to longer hospital stays and may affect the long-term health of the transplanted kidney. Over time, the kidney may begin to function normally, but the initial delay can complicate the recovery process. Monitoring and supportive care are essential during this period to ensure the best possible outcome for the transplant recipient.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-503091-89-00Protocol codeARGX-117-2201Estimated enrolment108 patientsSponsorArgenx

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