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New therapy found effective against rejection in kidney transplantation
Last reviewed: 02.07.2025
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Antibody-mediated rejection (AMR) is one of the most common causes of kidney transplant failure. However, no treatment has been found to effectively combat this complication in the long term.
An international and interdisciplinary clinical study led by Georg Böhming and Katharina Meyer from the Clinical Department of Nephrology and Dialysis of the Medical Faculty III, Medical University of Vienna and the University Hospital of Vienna has found a new therapeutic principle in transplant medicine that is safe and highly effective. The results were recently published in the New England Journal of Medicine.
The study included 22 patients diagnosed with AMR after kidney transplantation at the University Hospital Vienna and the Charité–Universitätsmedizin Berlin between 2021 and 2023. In the randomized, double-blind, placebo-controlled study, patients were given either the substance felsartamab or a drug with no pharmacological effect (placebo).
Felzartamab is a specific (monoclonal CD38) antibody originally developed as an immunotherapy to treat multiple myeloma by killing tumor cells in the bone marrow.
"Because of its unique ability to influence immune responses, felzartamab has also attracted attention in transplant medicine," explains study leader Boehming, noting that recent developments are largely due to his initiative.
"Our goal was to evaluate the safety and efficacy of the antibody as a potential treatment option for AMR after kidney transplantation," adds first author Mayer.
After a six-month treatment period and an equivalent observation period, the researchers were able to report encouraging results: morphological and molecular analysis of transplant biopsies showed that felzartamab has the potential to effectively and safely combat AMR in renal transplants.
With approximately 330 transplants performed annually, kidney transplantation is the most common form of organ transplantation in Austria. AMR is one of the most common complications, occurring when the organ recipient’s immune system produces antibodies against the foreign organ. This can lead to loss of kidney function, often requiring further dialysis or a repeat transplant.
AMR treatment is necessary not only for the health of patients, but also for the efficient use of donor organs, which are already in limited supply. "The results of our study could be a breakthrough in the treatment of kidney transplant rejection," Mayer concludes.
"Our findings also give hope that felzartamab may counteract the rejection of other donor organs, such as the heart or lungs. Perhaps xenotransplantation using genetically modified pig organs will also become a reality," adds Boehming.
This interdisciplinary phase II study, the first clinical trial demonstrating an effective treatment for late AMR, was conducted in collaboration with several departments of the Medical Faculty of the University of Vienna and the University Hospital Vienna, including the Department of Clinical Pharmacology (Bernd Gilma).
The study also involved international partners such as the Charité–Universitätsmedizin Berlin (Clemens Budde), the University Hospital Basel, the University of Alberta, Canada, and the US start-up Human Immunology Biosciences, among others. The next step, which is important for the approval of the drug, is to validate the results in a multi-centre phase III study, which is currently planned based on the current study results.