Felzartamab for Antibody-Mediated Rejection

(TRANSCEND LTE Trial)

This trial examines the safety of a drug called felzartamab for individuals who have undergone a kidney transplant and are experiencing antibody-mediated rejection (AMR). AMR occurs when the immune system attacks the new kidney, potentially causing long-term issues. This study serves as a follow-up, allowing participants from an earlier trial to continue treatment and observe how felzartamab affects their health over time. Individuals who participated in the previous study and received at least one dose of felzartamab are eligible to join. The trial includes regular health check-ups and treatment through an IV for up to four years. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to the potential availability of a new treatment.

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor to get a clear answer based on your specific situation.

Research has shown that felzartamab is generally safe for people with kidney transplants experiencing antibody-mediated rejection (AMR). In a recent study, patients demonstrated a good safety profile, meaning most handled the treatment well without major problems. Another study found that felzartamab reduced the risk of issues related to AMR. While no treatment is without risks, current evidence suggests that felzartamab is well-tolerated in similar patient groups.¹²³⁴⁵

Felzartamab is unique because it targets antibody-mediated rejection, which is a significant issue in organ transplant patients. Unlike standard treatments that often involve broad immunosuppressive drugs, felzartamab specifically targets CD38, a protein involved in the activity of plasma cells that produce harmful antibodies. This targeted approach may lead to more effective management of antibody-mediated rejection with potentially fewer side effects. Researchers are excited about felzartamab because it’s administered intravenously every eight weeks, offering a convenient and potentially longer-lasting option compared to current therapies.

Research has shown that felzartamab, a type of medication, can help prevent antibody-mediated rejection (AMR) in kidney transplant patients. In a recent study, patients who received felzartamab had a 77% lower risk of AMR compared to those who received a placebo, a substance with no active medication. The treatment was generally safe and well-tolerated. After 52 weeks, all patients in both the felzartamab and placebo groups survived, and no loss of the transplanted kidney occurred in the felzartamab group. These results suggest that felzartamab could effectively manage AMR in kidney transplant recipients. Participants in this trial will receive felzartamab intravenously once every 8 weeks for up to 200 weeks in the long-term extension period.²⁶⁷⁸⁹