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  • A Double-Blind, Placebo-Controlled, Multicenter, Randomized Phase 2 Trial Evaluating The Efficacy And Safety Of Felzartamab In Recipients Of Kidney Transplants With Late Isolated Microvascular Inflammation (MVI) Rochester, MN

    In this study, researchers will learn more about a drug called felzartamab in people who have received a kidney transplant and later developed a condition called microvascular inflammation (MVI). MVI is a type of injury to small blood vessels in the transplanted kidney and may be a sign of rejection by the body. It can lead to serious kidney problems over time.

    In many cases, MVI is caused by antibodies that attack the transplanted kidney. But in some people, MVI happens without these antibodies. This type of MVI is called isolated MVI. There are currently no approved treatments for isolated MVI.

    The main goal of the study is to learn about the effect felzartamab has on inflammation in the transplanted kidney. The main question researchers want to answer is:

    • How many participants have no signs of active inflammation in the transplanted kidney after 24 weeks of treatment with felzartamab?

    Researchers will also study how felzartamab affects kidney function, immune activity, and overall health. They will monitor safety through kidney biopsies, lab tests, and by recording adverse events throughout the study.

    Adverse events are health problems that may or may not be caused by the study drug.

    The study will be done in 2 parts as follows:

    * Participants will be randomly assigned to receive either felzartamab or a placebo. A placebo looks like the study drug but contains no real medicine.
    * In Part A, participants will receive their assigned drug for 24 weeks. Neither the researchers nor the participants will know who is receiving felzartamab or placebo.
    * Part B will last another 28 weeks. All participants will receive felzartamab and both participants and researchers will know this.
    * All treatments will be given by intravenous (IV) infusion at the study site.
    * Participants will have kidney biopsies at the start of the study, at Week 24, and at Week 52 to help measure changes in inflammation.
    * Participants will stay in the study for about 1 year.
  • An Open-Label Long-Term Extension Study For Participants From The 299AR301 Felzartamab Study Rochester, MN In this study, researchers will learn more about a drug called felzartamab in people who have received a kidney transplant and then developed a condition called antibody-mediated rejection (AMR). AMR happens when the body's immune system creates antibodies that attack the transplanted kidney. In late AMR, this happens more than 6 months after the kidney transplant. It can lead to serious kidney problems over time.

    An earlier study called 299AR301 (TRANSCEND) began in 2024 and is investigating felzartamab in participants with AMR. It includes a treatment period of about 1 year. It first compares treatment with felzartamab to placebo for about 6 months and then all participants are given felzartamab to complete the study. This study, 299AR301 LTE, is a long-term extension of the parent study 299AR301. Participants who join this study will have the opportunity to receive felzartamab for up to 4 more years.

    The goals of this study are to learn more about the long-term safety and effects of felzartamab in people with AMR. This study is part of a group of studies looking at long-term felzartamab use in people with organ transplants. This study is a substudy of the main study 299AR302.

    The main question researchers will answer relate to safety. Namely, how many participants have adverse events during the study and how lab test results change over time. Adverse events are health problems that may or may not be caused by the study drug.

    Researchers will perform kidney biopsies to track kidney health. Researchers will also study how felzartamab affects kidney inflammation, kidney function, immune activity, and overall health.

    The study will be done as follows:

    * Participants who complete the final visit of the treatment period in the parent study can enroll in this study. This includes participants who stopped receiving felzartamab early but still attended their final visits.
    * Participants who did not stop receiving felzartamab in the parent study will continue to receive felzartamab for up to 4 more years in this study. Participants may also stop felzartamab during this study at any time.
    * Participants who stopped receiving felzartamab in the parent study will only attend study visits for health monitoring- they will not receive felzartamab.
    * Felzartamab will be given as an intravenous (IV) infusion, which is a slow injection into a vein using a needle.
    * Participants receiving felzartamab may have up to 27 study visits over 200 weeks with an additional safety follow-up visit 4 weeks after their final dose.
    * Participants who are not receiving felzartamab may have up to 9 study visits over 200 weeks.
  • Assessment Of Biomarker-guided CNI Substitution In Kidney Transplantation Rochester, MN

    The purpose of the observational study is to determine the HLA-DR/DQ mMM score accurately stratifies kidney transplant recipients into low, intermediate, and high-risk categories for developing post-transplant alloimmune injury to the transplanted kidney.  The HLA-DR/DQ mMM score category will prognosticate risk of developing TCMR (clinically evident and subclinical), DSA and/or ABMR in the entire study cohort: higher HLA-DR/DQ mMM score confers higher likelihood of developing TCMR, DSA and or ABMR.

    The purpose of the nested RCT intervention is to determine transitioning immune quiescent kidney transplant recipients with low or intermediate HLA-DR/DQ mMM scores from a standard of care regimen to a CNI-free, abatacept-based regimen is safe and will lead to improved:

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