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Study of Felzartamab for Patients with Late Antibody-Mediated Rejection After Kidney 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 Antibody-Mediated Rejection (AMR) in patients who have received a kidney transplant. AMR is a situation where the body's immune system attacks the transplanted kidney, which can happen even long after the transplant. The study is testing a treatment called Felzartamab, which is being compared to a placebo. Felzartamab is a medication that is being investigated for its potential to help manage AMR in kidney transplant recipients.

The purpose of the study is to evaluate how effective Felzartamab is in treating patients with active or chronic active AMR. Participants in the study will receive either Felzartamab or a placebo through an intravenous infusion, which means the medication is given directly into a vein. The study will last for a period of up to 12 months, during which participants will have regular visits to monitor their health and the effects of the treatment.

In addition to Felzartamab, the study will also use a Saline Solution for infusion, which is a simple saltwater solution often used in medical treatments. The study aims to gather information on the safety and effectiveness of Felzartamab in improving the condition of kidney transplant recipients experiencing AMR. Participants will be closely monitored throughout the study to ensure their well-being and to collect data on how the treatment affects their condition.

The research process

The trial runs in 8 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, you will be asked to provide signed informed consent. This means you agree to participate after understanding the study's purpose and procedures.

  2. Step 2

    Initial screening

    You will undergo an initial screening to confirm eligibility. This includes a review of your medical history and a physical examination.

    A blood test will be conducted to ensure you meet the study's health criteria, including a negative pregnancy test for women of childbearing potential.

  3. Step 3

    Randomization

    You will be randomly assigned to receive either the study drug, felzartamab, or a placebo. This process is double-blind, meaning neither you nor the study team will know which you are receiving.

  4. Step 4

    Treatment phase

    During the treatment phase, you will receive the study drug or placebo through an intravenous infusion. This involves receiving the medication directly into your vein.

    The treatment will be administered according to the study schedule, which will be explained to you in detail by the study team.

  5. Step 5

    Regular monitoring

    You will have regular visits to the study site for monitoring. This includes blood tests, urine tests, and other assessments to track your health and the effects of the treatment.

    Your vital signs, such as blood pressure and heart rate, will be checked regularly.

  6. Step 6

    Mid-study evaluation

    At approximately 24 weeks, a mid-study evaluation will occur. This includes a review of your health status and any changes since the start of the study.

    A biopsy may be performed to assess the condition of your kidney transplant.

  7. Step 7

    Continuation of treatment

    You will continue to receive the study drug or placebo as per the schedule. Monitoring will continue to ensure your safety and the effectiveness of the treatment.

  8. Step 8

    Final evaluation

    At the end of the study period, a final evaluation will be conducted. This includes a comprehensive assessment of your health and the outcomes of the treatment.

    The study team will discuss the results with you and provide guidance on any further steps.

Who can join the trial?

15 criteria

  • Must be between 18 and 74 years old.
  • Must be willing and able to sign a consent form to participate in the study.
  • Must have a confirmed diagnosis of active or chronic active AMR (antibody-mediated rejection) without TCMR (T-cell mediated rejection) based on a kidney biopsy.
  • The kidney biopsy must have been done within the last 3 months, preferably within the last month.
  • Must have received a kidney transplant at least 6 months before the start of the study.
  • Must have good venous access for blood sampling and receiving the study drug through an IV (intravenous) line.
  • Must test positive for DSA (donor-specific antibodies) within 3 months before starting the study.
  • Must have an eGFR (estimated glomerular filtration rate) of at least 25 mL/min/1.73m², which is a measure of kidney function.
  • Must have a urine protein-creatinine ratio (UPCR) of less than 3.5 g/g, which measures protein levels in urine.
  • Must be up to date with all vaccines, such as COVID-19 and pneumococcus, as recommended by local health authorities.
  • Women who can have children must have a negative pregnancy test before starting the study and agree to use effective birth control methods during the study and for 90 days after the last dose of the study drug.
  • Men must agree to use effective birth control methods during the study and for 90 days after the last dose of the study drug.
  • Participants must agree not to donate sperm or eggs during the study and for 90 days after the last dose of the study drug.
  • Must be on a stable immunosuppression treatment plan as per local care standards.
  • Must be willing and able to attend all study visits, follow treatment plans, and complete all required tests and procedures.

Who cannot join the trial?

7 criteria

  • Patients who have not received a kidney transplant cannot participate. A kidney transplant is a surgery to place a healthy kidney from a donor into a person whose kidneys no longer function properly.
  • Patients who do not have late antibody-mediated rejection (AMR) cannot participate. AMR is a condition where the body's immune system attacks the transplanted kidney.
  • Patients who are not diagnosed with active or chronic active AMR cannot participate. "Active" means the condition is currently happening, and "chronic active" means it has been ongoing for a long time but is still active.
  • Patients who are not within the specified age range cannot participate. The age range includes both adults and children.
  • Patients who are not part of the specified clinical trial group cannot participate. This refers to specific groups of patients that the study is focusing on.
  • Patients who are not male or female cannot participate. The study includes both genders.
  • Patients who are not considered part of a vulnerable population cannot participate. Vulnerable populations may include groups like children, pregnant women, or those with certain health conditions.
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Investigated drugs

Felzartamab is a medication being studied for its potential to help people who have received a kidney transplant and are experiencing a condition called antibody-mediated rejection (AMR). This condition happens when the body's immune system attacks the new kidney, thinking it is a foreign object. Felzartamab works by targeting and reducing the activity of certain cells in the immune system that are responsible for this attack. The goal of using Felzartamab in this trial is to see if it can help protect the transplanted kidney by preventing or reducing the immune system's harmful response.

What is already known about the treatment

Felzartamab – Felzartamab is administered as an intravenous infusion, meaning it is delivered directly into the bloodstream through a vein. It is currently being studied in clinical trials for its effectiveness and safety in treating kidney transplant recipients who experience late antibody-mediated rejection, a condition where the immune system attacks the transplanted kidney. The medication works by targeting and reducing the activity of specific immune cells that contribute to this rejection process. Felzartamab is classified as an immunosuppressive agent, which means it helps to suppress the immune system to prevent it from attacking the transplanted organ.

Investigated diseases

Antibody-Mediated Rejection in Kidney Transplant Recipients – This condition occurs when the immune system of a kidney transplant recipient attacks the transplanted organ. It is characterized by the presence of antibodies that target the donor kidney, leading to inflammation and damage. Over time, this immune response can cause injury to the blood vessels and tissues of the transplanted kidney. The progression of the disease can result in decreased kidney function. If left unchecked, it may lead to chronic damage and scarring of the kidney tissue. The condition is monitored through various clinical assessments and laboratory tests to evaluate the extent of immune activity and kidney function.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-519095-66-00Protocol code299AR301Estimated enrolment127 patientsSponsorBiogen Idec Research Limited

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