Dose-Finding & CV Outcomes Study with CSL300 (Clazakizumab) in Adults with ESKD Undergoing Dialysis
Research type
Research Study
Full title
A Phase 2b / 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Combined Dose-Finding and Cardiovascular Outcome Study to Investigate the Efficacy and Safety of CSL300 (Clazakizumab) in Subjects with End Stage Kidney Disease Undergoing Dialysis
IRAS ID
1010097
Contact name
Anna Chang
Contact email
Sponsor organisation
CSL Behring LLC
Clinicaltrials.gov Identifier
Research summary
The purpose of this research study is to see if CSL300 (Clazakizumab) is effective and safe in patients on maintenance dialysis at reducing the risk of dying from heart-related events or having a heart attack. This is a 2 part study. Part 1 is now completed and an active dose of 5mg of CSL300 was found to reduce high-sensitivity c-reactive protein (hs-CRP) levels in a safe and well tolerated way.
In Part 2 there are 2 treatment groups (CSL300 or placebo), neither participants or study staff will know which treatment group has been assigned (blinded)and there is a 50/50 chance of being assigned to CSL300 or Placebo group.
Approx 2190 people will participate worldwide. It is split into 3 parts, screening, treatment & Safety Follow-up. Duration will be approx. 3-5 years with up to 69 study visits. At least 878 heart-related events are required to occur among all study participants before the study is stopped. If participant agrees and passes screening they will be entered into the study where they will receive study drug every 4 weeks during their dialysis sessions along with safety assessments.
Once the last dose is administered the study team will follow up for adverse events for up to 5 months.REC name
London - Fulham Research Ethics Committee
REC reference
24/LO/0476
Date of REC Opinion
1 Aug 2024
REC opinion
Further Information Favourable Opinion