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Evaluation of zirconium-89 crefmirlimab berdoxam PET imaging for monitoring renal allograft rejection in kidney transplant recipients

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What is this trial about?

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

The study focuses on people who have received a kidney transplant and may develop renal allograft rejection. An experimental imaging agent called Zr89 is given by an intravenous injection to help visualize immune cells, specifically CD8+ T cells, which are involved in the rejection process. The main goal is to see whether this new type of scan can provide useful information for monitoring transplant health.

Participants will receive a single injection of the imaging agent, followed by a series of imaging sessions that combine PET and CT scans to look at the transplanted kidney, nearby lymph nodes, spleen, liver and bone marrow. A small blood sample will also be taken to measure immune cells using a laboratory technique called flow cytometry. The study lasts for a short period of time after the injection, during which the imaging and blood tests are performed to assess the distribution of the agent and the activity of immune cells.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and consent

    After eligibility is confirmed, the patient signs the consent form and becomes a participant in the study.

  2. Step 2

    Baseline assessments

    A baseline blood sample is collected to measure immune cell levels.

    Clinical information about the kidney transplant and current health status is recorded.

  3. Step 3

    Administration of <b>zr89</b>

    The patient receives a single intravenous injection of zr89 at a dose of 44 mbq (megabecquerel).

    The injection is given as an aqueous solution for intravenous (iv) administration.

  4. Step 4

    Pet/ct imaging

    Shortly after the injection, the patient undergoes a pet/ct scan to capture images of the kidneys, lymph nodes, spleen, liver and bone marrow.

    The scan records the signal from the zr89-labeled antibody, which highlights cd8+ t cells.

  5. Step 5

    Post‑scan blood analysis

    A second blood sample is taken to quantify cd8+ t cells and other immune cell subsets using flow cytometry, a laboratory technique that counts cells.

  6. Step 6

    Follow‑up visits

    The patient returns for scheduled follow‑up visits during the study period.

    Additional blood samples may be collected and further imaging may be performed as defined by the study protocol.

  7. Step 7

    Study completion

    After the final assessments, the patient’s participation in the trial ends and the collected data are used for analysis.

Who can join the trial?

4 criteria

  • Be a kidney transplant recipient who fits into one of these groups: (a) no signs of rejection, (b) has a confirmed or suspected rejection and a kidney biopsy is planned, or (c) received T cell depleting antibodies within the past three months.
  • Be between 50 and 80 years old.
  • Sign a written informed consent form agreeing to take part in the study.
  • If you are female, you must either be post‑menopausal (no periods for at least 12 months after stopping all hormone treatments, or after surgical removal of the ovaries, or after radiation‑induced menopause) or have a negative serum pregnancy test and be using an effective method of birth control.

Who cannot join the trial?

9 criteria

  • Having an infection now or having had an infection within the last month. Infection means a sickness caused by bacteria, viruses, or other germs.
  • Having a long‑term liver problem. Chronic liver disease means the liver is damaged over a long period.
  • Being unable to sign a written consent form because of language difficulties or mental reasons. Written informed consent is a signed paper that shows you understand and agree to take part in the study.
  • Being unable to have a PET‑CT scan. PET‑CT scanning is a special imaging test that combines two types of pictures to look inside the body.
  • Being a woman who is currently pregnant or breastfeeding. Pregnant means carrying a baby, and breastfeeding means feeding a baby with breast milk.
  • Having received chemotherapy in the past. Chemotherapy is strong medicine used to treat cancer.
  • Having no functioning spleen. Asplenia means the spleen (an organ that helps fight infection) is missing or does not work.
  • Being a woman who could become pregnant and not willing to use reliable birth control from the start of the study until 33 days after the last dose. Reproductive potential means the ability to become pregnant, and birth control means methods used to prevent pregnancy.
  • Being a man who could father a child and not willing to use reliable birth control from the start of the study until 123 days after the last dose. Reproductive potential means the ability to father a child, and birth control means methods used to prevent pregnancy.
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Investigated drugs

Zr89 is a special imaging agent that is given through a vein. It contains a tiny amount of a radioactive form of zirconium attached to an antibody that seeks out CD8+ T cells, which are important immune cells. In this trial, the agent is used with a PET scan to create pictures of where these T cells are inside the body, especially in the kidneys, lymph nodes, spleen, liver, and bone marrow. By looking at these images, researchers hope to learn whether this method can help monitor kidney transplants and detect rejection early.

What is already known about the treatment

Zr89 - This investigational radiopharmaceutical is supplied as an aqueous solution for intravenous injection, typically given at 44 MBq. It is used to image CD8‑positive T cells in patients with kidney transplants to help detect rejection. The drug works by attaching a tiny amount of the radioactive element zirconium‑89 to an antibody that seeks out CD8 cells; the radioactivity is then captured by a PET scanner to produce pictures of where the cells are located. It belongs to the class of diagnostic radiotracers and is currently only available within clinical studies.

Investigated diseases

Renal allograft rejection - Renal allograft rejection is an immune response in which the body attacks a transplanted kidney. The reaction starts when immune cells recognize the donor kidney as foreign and become activated. These cells then cause inflammation and damage to the kidney tissue, gradually reducing its ability to filter waste. As the process continues, the transplanted kidney may lose its normal function in maintaining fluid and electrolyte balance.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2025-522490-11-00Protocol codeR0043300Estimated enrolment9 patientsSponsorStichting Radboud universitair medisch centrum

sourced from the EU Clinical Trials Register and site verification

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