Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD Undergoing Dialysis (POSIBIL6ESKD)

To be considered for this study, you need to be an adult, aged 18 or over. You must have advanced kidney disease (End-Stage Kidney Disease or ESKD) and have been receiving dialysis regularly for at least 12 weeks. We are specifically looking for people who show signs of inflammation in their body and who also have either a known heart and blood vessel disease or diabetes.

There are some reasons why you might not be able to join. For example, if you've already taken part in the earlier dose-finding stage of this study, you won't be able to join the later part. We also can't include people who are taking certain medications that suppress the immune system, or if you have certain liver problems. If you have a life-threatening illness expected to shorten your life significantly within the next year, you won't be eligible.

Other reasons for not being able to participate include a history of certain bowel conditions like a tear in the gut, inflammatory bowel disease (unless it was fully removed), or stomach ulcers. You also can't have an active serious infection, or a history of specific serious fungal infections.

If you decide to take part in this study, you will be in it for a while, as it involves several visits over an extended period. You will have regular appointments at the study clinic where you'll have various health checks, blood tests, and other assessments. You'll be given either the study medicine, CSL300, or a placebo, which you'll take as instructed. The study team will carefully monitor your health and any effects of the medicine throughout this time. After the main treatment period, there will be a follow-up phase to continue monitoring your health and gather all necessary information. The exact number of visits and their frequency will be explained in detail by the study team.