Novo Aripuana

Researchers are evaluating felzartamab in adults who have received a kidney transplant and later developed microvascular inflammation (MVI), a type of injury to small blood vessels in the transplanted kidney. This inflammation may indicate rejection by the body and can cause serious kidney problems over time. The study focuses especially on a form called isolated MVI, which occurs without antibodies and currently has no approved treatments. The main goal is to understand how felzartamab affects inflammation in the transplanted kidney compared to a placebo. The study is a Phase 2, double-blind, placebo-controlled trial with two parts. In Part A, participants are randomly assigned to receive either felzartamab or placebo through intravenous (IV) infusion for 24 weeks without knowing which treatment they receive. In Part B, lasting 28 weeks, all participants receive felzartamab openly. Kidney biopsies are performed at the start, Week 24, and Week 52 to assess changes in inflammation. The trial includes monitoring kidney function and immune activity alongside safety assessments. Participants will be involved for about one year, undergoing kidney biopsies, lab tests, and regular health evaluations. Researchers will collect data on biopsy-proven histologic resolution of inflammation at Week 24 as the primary outcome. Safety is monitored through adverse event reporting and additional clinical measures. The study also includes assessments of felzartamab's pharmacokinetics and immunogenicity during both parts of the trial.

Researchers are studying the effects of felzartamab, a laboratory-made antibody, in adults who have received kidney transplants and are experiencing antibody-mediated rejection (AMR). AMR happens when the immune system mistakenly attacks the new kidney, causing damage that can lead to organ failure. This phase 3 trial aims to compare felzartamab to a placebo to see how well it helps treat AMR in kidney transplant patients. The study focuses on how many participants have kidney tissue that looks normal or nearly normal after 24 weeks of treatment. Participants will be randomly assigned to receive up to 9 doses of either felzartamab or a placebo through an intravenous infusion based on their body weight during the first part of the study, which lasts up to 24 weeks and is double-blind. In the second part, lasting up to 28 weeks, all participants will receive felzartamab in an open-label phase where everyone knows the treatment being given. In total, participants will have up to 21 study visits over about one year. During the study, participants will undergo kidney biopsies, blood and urine tests, electrocardiograms, and other assessments to monitor kidney function, immune response, and safety. Researchers will measure how long the transplanted kidney works, changes in antibody levels, signs of rejection, and side effects. The study also monitors how felzartamab is processed by the body and whether participants develop antibodies against the drug. Screening before enrollment can take up to 42 days.