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A Study of Felzartamab for Kidney Transplant Patients with Late Isolated Microvascular Inflammation

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 study involves people who have received a kidney transplant and have developed a condition called late isolated microvascular inflammation. This is a type of inflammation that affects the small blood vessels in the transplanted kidney and can occur months or years after the transplant. The inflammation can happen even when certain antibodies that usually cause rejection are not present in the blood. The study will test a medication called felzartamab, which is also known by its code name MOR202. Some participants will receive felzartamab while others will receive placebo. The medication is given through a vein as an infusion. A saline solution containing sodium chloride will be used during the infusion process.

The purpose of the study is to find out if felzartamab works better than placebo in treating this type of inflammation in transplanted kidneys. The study will also look at whether the medication is safe and how it affects kidney function over time. The inflammation is identified through a kidney biopsy, which is a procedure where a small piece of kidney tissue is examined under a microscope. The study will check if the medication can reduce or eliminate the inflammation seen in the biopsy and whether it can help maintain or improve how well the transplanted kidney is working.

The study is divided into different parts and will last for about one year for each participant. During this time, participants will receive the study medication or placebo through infusions at scheduled visits. Throughout the study, participants will have regular check-ups that include blood tests, urine tests, measurements of vital signs like blood pressure and heart rate, and tests to check how well the kidney is functioning. Another kidney biopsy will be performed during the study to see if there are any changes in the inflammation. The study will also monitor for any side effects or unwanted reactions to the medication.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    Upon entering the study, your current immunosuppression regimen (medications that prevent your body from rejecting the transplanted kidney) will continue according to standard care at your treatment center. This regimen must remain stable throughout the screening period.

    You will receive either felzartamab or placebo (an inactive substance) through intravenous infusion (a slow injection into your vein). The assignment to felzartamab or placebo will be random, and neither you nor your doctor will know which one you receive.

    The infusion will be prepared using either felzartamab powder that is mixed with liquid, or a saline solution (salt water). The infusion will be administered directly into your vein.

    You must have suitable vein access to allow for blood sample collection and administration of the study medication.

  2. Step 2

    Week 24 assessment

    At week 24 (approximately 6 months after starting treatment), a kidney biopsy will be performed. This involves taking a small tissue sample from your transplanted kidney to examine it under a microscope.

    The biopsy will assess whether there is biopsy-proven histologic response, which means checking if the inflammation in the small blood vessels of your kidney has improved.

    Your kidney function will be measured using a calculation called eGFR (estimated glomerular filtration rate), which indicates how well your kidney is filtering waste from your blood. The change from the beginning of the study will be evaluated.

    Blood tests will be performed to check your overall health and kidney function.

    Your vital signs (such as blood pressure, heart rate, and temperature) will be measured, and an ECG (electrocardiogram, a test that records the electrical activity of your heart) will be performed.

  3. Step 3

    Continuation phase (Part B, Arm 1 or Arm 2)

    Depending on the results at week 24 and which treatment group you are assigned to, you may continue in one of two pathways.

    If you are in Arm 1, you will continue with the same treatment (either felzartamab or placebo) that you received during the first 24 weeks.

    If you are in Arm 2, the treatment approach may be adjusted based on your response at week 24.

    During this phase, regular monitoring of your kidney function, blood tests, vital signs, and ECG will continue according to the study schedule.

  4. Step 4

    Week 52 assessment

    At week 52 (approximately 12 months after starting treatment), another kidney biopsy will be performed to assess the inflammation in your kidney's small blood vessels.

    Your kidney function will again be measured using eGFR to determine any changes since the beginning of the study.

    Blood tests, vital signs, and ECG will be performed to monitor your overall health and safety.

    The presence of any T-cell mediated rejection (a type of immune response where your body's T-cells attack the transplanted kidney) will be assessed through the biopsy.

  5. Step 5

    Ongoing monitoring throughout the study

    Throughout the entire study period, any adverse events (unwanted or harmful effects that occur during treatment) will be recorded and assessed for their severity.

    Special attention will be given to serious adverse events (events that require hospitalization, are life-threatening, or cause significant disability) and adverse events of special interest (specific side effects that are particularly important to monitor).

    Regular laboratory tests will monitor your blood counts, kidney function, liver function, and other important health markers.

    The time to allograft loss (complete failure of the transplanted kidney) will be tracked throughout the study.

  6. Step 6

    End of study

    The study is expected to conclude in April 2028.

    After receiving your last dose of study medication, you must continue using highly effective contraception (birth control methods) for 90 days if you are of childbearing potential or assigned male at birth.

    Male participants must not donate sperm, and female participants must not donate eggs during the study and for 90 days after the last dose of study medication.

    Final assessments will be completed to evaluate your kidney function, overall health, and any long-term effects of the treatment.

Who can join the trial?

15 criteria

  • You must be at least 18 years old and younger than 75 years old when you agree to join the study.
  • Within 4 weeks before starting the study, you should be up to date with all recommended vaccines according to your local health guidelines, such as vaccines for COVID-19 and pneumonia. If you need live vaccines, these must be given at least 4 weeks before the study begins.
  • If you are a woman who can become pregnant, you must have a negative blood pregnancy test during the initial check-up and a negative urine pregnancy test right before receiving the first dose of the study medicine.
  • If you are a man or a woman who can become pregnant and you have sexual intercourse that could lead to pregnancy, you must agree to use approved birth control methods starting from the initial check-up, throughout the study, and until 90 days after your last dose of the study medicine.
  • Men must agree not to donate sperm, and women must agree not to donate eggs from the start of the study until 90 days after the last dose of the study medicine.
  • You must currently be taking a stable regimen of medicines that prevent your body from rejecting the transplanted kidney, following your local medical care standards. Any changes to these medicines during the screening period will require a new check to see if you can still join the study.
  • You must be willing and able to attend all study visits, follow treatment plans, complete required tests, and meet all other study requirements.
  • You must be able and willing to sign a consent form before any study procedures begin.
  • You must have a condition called microvascular inflammation, which is inflammation in the small blood vessels of your transplanted kidney, confirmed by a tissue sample. This condition can be either C4d-positive or C4d-negative, which are markers detected in the tissue, and must be DSA-negative, meaning certain antibodies that could harm the kidney are not present. You must not have another type of rejection called TCMR, which stands for T-cell-mediated rejection.
  • The tissue sample, called a biopsy, must have been taken within 3 months before joining the study, preferably within 1 month. If you received any previous treatment for rejection or inflammation, the biopsy must be done at least 6 weeks after finishing that treatment.
  • You must have received your kidney transplant at least 6 months before the initial study visit. The kidney can be from either a living or deceased donor.
  • You must have adequate access to veins so that blood samples can be taken and the study medicine can be given through an intravenous line.
  • You must have negative results for certain antibodies called DSA, which are donor-specific antibodies against proteins on the kidney. These antibodies must be tested within 3 months before joining the study. If you received previous treatment for rejection or inflammation, the antibody test must be done at least 6 weeks after finishing that treatment.
  • Your kidney function, measured by eGFR, which stands for estimated glomerular filtration rate and shows how well your kidneys filter waste, must be at least 25 milliliters per minute per 1.73 square meters of body surface area.
  • The amount of protein in your urine compared to creatinine, measured by UPCR, which stands for urine protein-to-creatinine ratio, must be less than 3.5 grams per gram.

Who cannot join the trial?

6 criteria

  • The study does not list specific exclusion criteria in the provided information, which means the reasons why patients cannot participate are not detailed in this data
  • Generally, clinical trials have exclusion criteria to ensure patient safety and study accuracy, but these specific details would need to be obtained from the complete study documentation
  • If you are considering participation in this study about microvascular inflammation (inflammation of small blood vessels) after kidney transplant (receiving a donated kidney), you would need to discuss your individual situation with the research team
  • The study involves patients who have received a kidney transplant and have been diagnosed with a specific type of inflammation in the small blood vessels of the transplanted kidney
  • Both men and women can participate in this study
  • The study includes adults and elderly patients
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Investigated drugs

  • Felzartamab

    is an experimental medication being tested in this clinical trial for people who have received a kidney transplant and are experiencing a specific type of inflammation in the small blood vessels of their transplanted kidney. This medication is designed to help reduce this inflammation and protect the transplanted kidney from damage.

  • Placebo

    is an inactive substance that looks like the real medication but contains no active ingredients. It is used in this study to compare against felzartamab to help researchers understand if the experimental medication is truly effective.

What is already known about the treatment

Felzartamab – Felzartamab is an investigational medication currently being studied in clinical trials for the treatment of late isolated microvascular inflammation in kidney transplant recipients. This medication is administered as an infusion into a vein and works by targeting specific immune system proteins called CD38, which are found on certain white blood cells that contribute to inflammation and rejection of transplanted organs. The drug belongs to a class of medications known as monoclonal antibodies, which are designed to precisely target and block specific molecules in the body. In this phase 2 clinical trial, researchers are evaluating whether felzartamab can effectively reduce microvascular inflammation in transplanted kidneys and help prevent organ rejection in patients who show signs of inflammation without detectable donor-specific antibodies.

Investigated diseases

Microvascular Inflammation – Microvascular inflammation is a condition that occurs in kidney transplant recipients where the small blood vessels in the transplanted kidney become inflamed. This inflammation affects the tiny vessels within the kidney tissue and can occur even when certain antibodies are not present in the blood. The condition may develop months or years after the kidney transplant has been performed. It can be identified by examining kidney tissue samples under a microscope, where signs of inflammation in the small blood vessels become visible. The inflammation may be associated with the presence or absence of a protein called C4d in the kidney tissue. Over time, this ongoing inflammation in the small blood vessels can affect how well the transplanted kidney functions.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-521742-15-00Protocol code299AR201Estimated enrolment81 patientsSponsorBiogen Idec Research Limited

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