Kidney transplants can fail due to a complication called antibody-mediated rejection (AMR), where the immune system attacks the transplanted organ.
Until now, no treatment has effectively addressed this issue in the long term.
However, a new therapy tested by an international team led by Georg Böhmig and Katharina Mayer from MedUni Vienna and University Hospital Vienna offers hope.
The results of this promising study were published in the New England Journal of Medicine.
The research involved 22 kidney transplant patients diagnosed with AMR at University Hospital Vienna and Charité–Universitätsmedizin Berlin between 2021 and 2023. In this randomized, double-blind, placebo-controlled study, patients received either a new drug called felzartamab or a placebo.
Felzartamab is a monoclonal antibody originally developed to treat multiple myeloma, a type of bone marrow cancer.
It works by eliminating tumor cells in the bone marrow. Because of its ability to influence immune reactions, researchers believed it could also help in transplant medicine.
“Our goal was to assess the safety and effectiveness of felzartamab as a treatment for AMR after kidney transplantation,” said first author Mayer.
After six months of treatment and another six months of observation, the results were promising. Morphological and molecular analyses of kidney biopsies showed that felzartamab could effectively and safely combat AMR in kidney transplants.
This is a significant breakthrough because kidney transplants are the most common type of organ transplant in Austria, with around 330 performed each year.
AMR is a major complication that can lead to kidney failure, necessitating further dialysis or another transplant. Effective treatment for AMR is crucial for patient health and the optimal use of donor organs.
“The results of our study could represent a breakthrough in the treatment of kidney transplant rejection,” Mayer summarized.
The study’s findings also suggest that felzartamab could help prevent rejection in other types of transplants, such as heart or lung transplants.
It may even aid in the success of xenotransplants, where genetically modified pig organs are used.
This groundbreaking Phase II study, which is the first to demonstrate an effective treatment for late AMR, involved several departments at MedUni Vienna and University Hospital Vienna.
It also included international collaborations with Charité–Universitätsmedizin Berlin, University Hospital Basel, the University of Alberta in Canada, and the US start-up Human Immunology Biosciences.
The next step is to validate these results in a multicenter Phase III study, which is currently being planned. If successful, this new therapy could revolutionize the treatment of kidney transplant rejection and improve outcomes for many patients.
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