Long-term Follow-up Trial of Patients Previously Treated With Imlifidase Prior to Kidney Transplantation Including a Non-comparative Concurrent Reference Group

What this Trial Is About

Researchers are conducting a long-term follow-up trial for patients who previously received imlifidase treatment before kidney transplantation. This trial includes patients from a prior study (PAES trial) who were transplanted with a new kidney, either after imlifidase treatment or standard care medication. The aim is to continue evaluating kidney function and safety over time, fulfilling European Medicines Agency requirements. Participants include those treated with imlifidase, an enzyme that breaks down certain antibodies to prevent kidney rejection, or those who received the best available treatment as per standard transplantation routines. The study follows patients for up to five years after transplantation to collect ongoing data. During the trial, patients will be monitored regularly for kidney graft survival, kidney function tests like estimated Glomerular Filtration Rate and creatinine levels, antibody levels, rejection episodes, treatment of rejections, adverse events, and life participation changes. The trial tracks these outcomes at 2, 3, and 5 years post-transplantation to understand long-term efficacy and safety, with participation lasting up to five years.

A Long-term Follow-up Trial of Patients Previously Treated With Imlifidase Prior to Kidney Transplantation and a Non-comparative Transplanted Patient Group