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OM336 for Desensitization in Patients with End-Stage Renal Failure Awaiting Kidney Transplantation

Verified siteRegistered drugNo placebo
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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 studying end stage renal failure in people who are waiting for a kidney transplant. The treatment being tested is OM336, given as a subcutaneous injection under the skin. The study also includes background medicines that may be used before treatment: paracetamol, buclizine hydrochloride, codeine phosphate, valaciclovir, dexamethasone acetate, and diphenhydramine. The purpose of the study is to see whether OM336 is safe and well tolerated and whether it can help reduce the immune response that can make kidney transplantation harder.

The study follows people over time while they receive OM336 and regular checkups. A dose is given, and then health is monitored for side effects and other changes related to the immune system. If a kidney transplant happens during the study, follow-up continues after the transplant to watch for safety and other changes. The study lasts for about 2 years after treatment starts for each person, with repeated visits during that period.

The research process

The trial runs in 10 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Trial start and treatment period

    You join an open-label phase ii a trial. Open-label means the treatment is known and not hidden.

    You receive om336 as a subcutaneous injection under the skin at a dose of 60 mg. The schedule for this injection is not specified in the source data.

    You also receive the background medicines listed for the trial by oral use: paracetamol 1000 mg, valaciclovir 500 mg, dexamethasone 8 mg, and diphenhydramine 50 mg. The source data does not give the frequency or duration for these medicines.

    The trial begins with this treatment period and continues for the planned follow-up over time.

  2. Step 2

    Week 24 assessment

    At week 24, your safety and how well you tolerate om336 are checked.

    At week 24, your vPRA level is checked. vPRA means a blood test result used to show how much sensitization you have to tissue types needed for kidney transplantation.

  3. Step 3

    Follow-up at month 3

    At month 3, your vPRA is checked.

    At month 3, donor frequency is assessed using the ET donor calculator.

    At month 3, the number of unacceptable antigens that can be delisted is assessed. Antigens are markers that the immune system can recognize.

    At month 3, if you receive a living donor kidney transplant, the MFI of the most important DSA is measured. MFI means a measure of how strong an antibody signal is. DSA means donor-specific antibody, which is an antibody directed against the donor.

    At month 3, safety and tolerability continue to be checked.

    At month 3, the following are measured: om336 drug level in the body, anti-drug antibodies (antibodies against the study drug), IgG, IgM, IgA, free light chains, blood group and xeno-reactive antibodies, vaccination titers including hepatitis B, TTV load, peripheral blood B cells, peripheral blood T cells, peripheral blood transcriptome analysis, sBCMA, blood cytokines, chemokines, and markers of inflammation. Transcriptome analysis means a test that looks at active genetic material in the blood.

  4. Step 4

    Follow-up at month 6

    At month 6, your vPRA is checked.

    At month 6, donor frequency is assessed using the ET donor calculator.

    At month 6, the number of unacceptable antigens that can be delisted is assessed.

    At month 6, if you receive a living donor kidney transplant, the MFI of the most important DSA is measured.

    At month 6, safety and tolerability continue to be checked.

    At month 6, the following are measured: om336 drug level in the body, anti-drug antibodies, IgG, IgM, IgA, free light chains, blood group and xeno-reactive antibodies, vaccination titers including hepatitis B, TTV load, peripheral blood B cells, peripheral blood T cells, peripheral blood transcriptome analysis, sBCMA, blood cytokines, chemokines, and markers of inflammation.

  5. Step 5

    Follow-up at month 9

    At month 9, peripheral blood B cell counts and peripheral blood T cell counts are measured.

    At month 9, peripheral blood transcriptome analysis is performed.

    At month 9, sBCMA, blood cytokines, chemokines, and markers of inflammation are measured.

    At month 9, safety and tolerability continue to be checked.

  6. Step 6

    Follow-up at month 12

    At month 12, your vPRA is checked.

    At month 12, donor frequency is assessed using the ET donor calculator.

    At month 12, the number of unacceptable antigens that can be delisted is assessed.

    At month 12, if you receive a living donor kidney transplant, the MFI of the most important DSA is measured.

    At month 12, safety and tolerability continue to be checked.

    At month 12, the following are measured: om336 drug level in the body, anti-drug antibodies, IgG, IgM, IgA, free light chains, blood group and xeno-reactive antibodies, vaccination titers including hepatitis B, TTV load, peripheral blood B cells, peripheral blood T cells, peripheral blood transcriptome analysis, sBCMA, blood cytokines, chemokines, and markers of inflammation.

  7. Step 7

    Follow-up at month 15

    At month 15, your vPRA is checked.

    At month 15, donor frequency is assessed using the ET donor calculator.

    At month 15, the number of unacceptable antigens that can be delisted is assessed.

    At month 15, if you receive a living donor kidney transplant, the MFI of the most important DSA is measured.

    At month 15, safety and tolerability continue to be checked.

    At month 15, the following are measured: om336 drug level in the body, anti-drug antibodies, IgG, IgM, IgA, free light chains, blood group and xeno-reactive antibodies, vaccination titers including hepatitis B, TTV load, peripheral blood B cells, peripheral blood T cells, peripheral blood transcriptome analysis, sBCMA, blood cytokines, chemokines, and markers of inflammation.

  8. Step 8

    Follow-up at month 18

    At month 18, your vPRA is checked.

    At month 18, donor frequency is assessed using the ET donor calculator.

    At month 18, the number of unacceptable antigens that can be delisted is assessed.

    At month 18, if you receive a living donor kidney transplant, the MFI of the most important DSA is measured.

    At month 18, safety and tolerability continue to be checked.

    At month 18, the following are measured: om336 drug level in the body, anti-drug antibodies, IgG, IgM, IgA, free light chains, blood group and xeno-reactive antibodies, vaccination titers including hepatitis B, TTV load, peripheral blood B cells, peripheral blood T cells, peripheral blood transcriptome analysis, sBCMA, blood cytokines, chemokines, and markers of inflammation.

  9. Step 9

    Follow-up at month 21

    At month 21, your vPRA is checked.

    At month 21, donor frequency is assessed using the ET donor calculator.

    At month 21, the number of unacceptable antigens that can be delisted is assessed.

    At month 21, if you receive a living donor kidney transplant, the MFI of the most important DSA is measured.

    At month 21, safety and tolerability continue to be checked.

    At month 21, the following are measured: om336 drug level in the body, anti-drug antibodies, IgG, IgM, IgA, free light chains, blood group and xeno-reactive antibodies, vaccination titers including hepatitis B, TTV load, peripheral blood B cells, peripheral blood T cells, peripheral blood transcriptome analysis, sBCMA, blood cytokines, chemokines, and markers of inflammation.

  10. Step 10

    Final follow-up at month 24

    At month 24, your vPRA is checked.

    At month 24, donor frequency is assessed using the ET donor calculator.

    At month 24, the number of unacceptable antigens that can be delisted is assessed.

    At month 24, if you receive a living donor kidney transplant, the MFI of the most important DSA is measured.

    At month 24, safety and tolerability are checked.

    At month 24, the following are measured: om336 drug level in the body, anti-drug antibodies, IgG, IgM, IgA, free light chains, blood group and xeno-reactive antibodies, vaccination titers including hepatitis B, TTV load, peripheral blood B cells, peripheral blood T cells, peripheral blood transcriptome analysis, sBCMA, blood cytokines, chemokines, and markers of inflammation.

    Safety is also reviewed for at least 12 months after transplantation if a transplant happens during the trial.

Who can join the trial?

15 criteria

  • Be a male or female patient between 18 and 70 years old when signing the consent form.
  • Be able and willing to sign an informed consent form (a written form saying you understand the study and agree to take part) before any study tests or procedures that are not part of usual care.
  • Be able and willing to follow all study requirements, including visits, treatment, procedures, laboratory tests, and other instructions, with a good chance of finishing the study.
  • Be a highly sensitized transplant candidate on the deceased donor waiting list, meaning the immune system has many HLA antibodies (antibodies are proteins made by the immune system that can attack foreign tissue), and meet one of these conditions for at least 24 months:
    • Be enrolled in the Eurotransplant Acceptable Mismatch (AM) program with a vPRA above 85%. vPRA means a percentage that estimates how hard it may be to find a compatible donor.
    • Be enrolled in the Eurotransplant Kidney Allocation System (ETKAS) with a vPRA above 95%, but not meet the AM program rules because some antibodies are considered unacceptable by the local transplant center.
    • For the deceased donor waiting list group, a blood sample taken at screening must be diluted 1:100 and then show:
      • a clear decrease in HLA antibody strength, and
      • a decrease in vPRA by at least 1.0%.
      • Be a living donor kidney transplant candidate with the following:
        • unacceptable DSA against the planned donor, where DSA means antibodies directed against a specific donor, and
        • no option for kidney paired donation (KPD), which is a program that matches donor-recipient pairs to help find a compatible transplant, or be in a KPD program but have had no transplant offer after 12 months on the list.
        • For the living donor group, a blood sample taken at screening must be diluted 1:100 and then show:
          • a negative DSA result, or
          • a clear decrease in DSA strength to levels that the local laboratory considers acceptable.
          • If you are a woman who can become pregnant, you must have a negative pregnancy test at screening using a very sensitive test.
          • If you are a woman who can become pregnant, or a sexually active man who can have children, you must agree to use a highly effective birth control method with less than 1% chance of failure per year during the study and for 150 days after the last dose of study drug.
          • Women and men must agree not to donate eggs (also called ova or oocytes) or sperm during the study and for 90 days after the last dose of study drug.
          • Be up to date on all vaccines recommended by the local public health authority within 4 weeks before randomization, which is the process of being assigned to a study group by chance.

Who cannot join the trial?

19 criteria

  • Having had prior treatment with a therapy that targets B Cell Maturation Antigen (BCMA) or any other CD3-redirecting drug (a medicine designed to direct immune cells in a specific way).
  • Having an active infection with hepatitis B, hepatitis C, or HIV (human immunodeficiency virus).
  • Having a serious infection within the last 3 months that needed hospital care or medicine given through a vein.
  • Having any infection within the last 2 weeks that needed antibiotics or another antimicrobial medicine taken by mouth.
  • Having a history of cancer within the past 5 years, except for some skin cancers that were fully treated, cervical carcinoma in situ that was fully treated with no return, or certain low-risk prostate cancer that is being watched only.
  • Having received a live vaccine within 3 months before screening. A live vaccine contains a weakened form of a germ.
  • Having uncontrolled mental health problems, such as alcohol or drug abuse, dementia (memory and thinking problems), or another change in mental state that would prevent joining the study.
  • Having poor liver function at screening, including bilirubin higher than 2 times the normal limit, or ALT or AST higher than 3 times the normal limit. These are blood tests that show how the liver is working.
  • Currently taking part in, or having recently taken part in, another clinical study with an investigational drug or device within the last 30 days or within 5 drug half-lives, whichever is longer. A half-life is the time it takes for half of a drug to leave the body.
  • Having any other serious illness that, in the investigator’s judgment, could make study participation unsafe, affect the results, or make it hard to follow the study plan, including not taking medicines as directed.
  • Having a known allergy to dexamethasone, diphenhydramine, acetaminophen, or valacyclovir, or to any of their ingredients.
  • Having taken medicines that are not allowed by the study within the time periods listed in the study rules.
  • Having had a severe allergic reaction or a life-threatening allergic reaction called anaphylaxis to monoclonal antibody treatments or any part of OM336. Monoclonal antibodies are laboratory-made proteins used as medicines.
  • Having a congenital immune system disorder with repeated serious infections in the last 12 months. Congenital means present from birth.
  • Having had desensitization treatment within 6 months before randomization, including any of the following: apheresis therapy such as plasmapheresis or immunoadsorption, CD20 monoclonal antibodies such as rituximab, CD38 monoclonal antibodies such as daratumumab, proteasome inhibitors such as bortezomib or carfilzomib, tocilizumab, imlifidase, or any other investigational agent.
  • Being pregnant or breastfeeding and unwilling to use effective birth control, if the patient could become pregnant.
  • Having lung problems that require long-term oxygen therapy to keep oxygen levels normal.
  • Having herpes simplex virus infection or symptomatic herpes zoster (shingles with symptoms) within 3 months before screening, or a past history of shingles that spread widely, affected the eye, or affected the brain or spinal cord.
  • Having active tuberculosis or latent tuberculosis (a hidden infection that is not causing symptoms now) based on testing, medical history, examination, or chest X-ray.
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Investigated drugs

  • OM336

    is the study drug being tested in this trial. It is given as a subcutaneous injection, which means it is injected under the skin. The goal is to see whether it is safe and well tolerated, and whether it can help lower HLA sensitization in kidney transplant candidates, which may make it easier for them to receive a kidney transplant.

  • Paracetamol

    is an oral medicine used as part of the background treatment in the trial. It is commonly used to help relieve pain and reduce fever, and in this study it is given to support patients while they receive the study treatment.

  • Valaciclovir

    is an oral antiviral medicine used as background treatment. It helps prevent infections caused by certain viruses, especially herpes viruses, during the trial period.

  • Dexamethasone

    is an oral steroid medicine used as background treatment. It helps reduce inflammation and can also help lower the body’s immune response, which may be useful around the time of treatment.

  • Diphenhydramine

    is an oral medicine used as background treatment. It is an antihistamine that can help prevent or reduce allergic-type reactions, such as itching or swelling, during the trial.

What is already known about the treatment

  • Paracetamol

    Paracetamol is given by mouth as a tablet or similar oral form, and it is widely used in medicine and well described in medical literature. It is mainly used to relieve pain and reduce fever, and it is considered a common painkiller and fever reducer. It works by lowering the production of chemical signals in the brain and nervous system that cause pain and raise body temperature, making it useful for mild to moderate pain and fever. It belongs to the group of non-opioid analgesics and antipyretics, and in this trial it appears as part of background treatment.

  • Valaciclovir

    Valaciclovir is taken by mouth as an oral tablet, and it is a well-established medicine with extensive use in clinical practice and medical literature. It is mainly used to treat infections caused by herpes viruses, such as cold sores, genital herpes, and shingles. After being absorbed, it is changed in the body into aciclovir, which blocks a viral enzyme needed for the virus to make new genetic material, thereby slowing viral growth. It belongs to the group of antiviral medicines, specifically herpes virus medicines, and it is used here as background treatment.

  • Dexamethasone

    Dexamethasone is taken by mouth as a tablet, and it is a long-used medicine that is well known in medical practice and research. It is mainly used to reduce inflammation and to treat allergic reactions, some hormone problems, and other conditions where the immune system needs to be calmed down. It works by entering cells and changing how certain genes are switched on or off, which reduces the release of substances that cause swelling, redness, and immune activity. It belongs to the group of corticosteroids, and in this trial it is used as background treatment.

  • Diphenhydramine

    Diphenhydramine is given by mouth as an oral medicine, and it is a well-known drug that has been used for many years and is widely described in medical literature. It is mainly used for allergy symptoms such as runny nose, itching, and hives, and it can also cause drowsiness, which is sometimes useful in short-term symptom relief. It works by blocking histamine, a natural body chemical that triggers allergy symptoms, at a receptor called the H1 receptor. It belongs to the group of first-generation antihistamines, and in this trial it appears as background treatment.

  • OM336

    OM336 is given as a subcutaneous injection, which means it is injected just under the skin, and it is an experimental medicine with limited published information because it is still being studied. It is being tested to help desensitize kidney transplant candidates by lowering harmful immune responses before transplantation. It is a T cell engager, meaning it is designed to connect to T cells and guide the immune system in a very targeted way, with the goal of changing how certain immune cells react and reducing HLA sensitization. Its pharmacological class is investigational immunotherapy, specifically a T cell-engaging antibody-based treatment.

Investigated diseases

End-stage renal failure - A condition in which the kidneys lose nearly all of their normal function and can no longer adequately remove waste and extra fluid from the body. It usually develops after long-term kidney damage gets progressively worse over time. As kidney function continues to decline, waste products and fluid build up and the body’s balance of salts and other substances is disrupted. Symptoms and complications tend to increase as the kidney failure advances.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-523222-40-00Estimated enrolment6 patientsSponsorMedical University Of Vienna

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