Cardiometabolic & kidneyRandomised controlled trial
IL-6 inhibition with clazakizumab in patients receiving maintenance dialysis: a randomized phase 2b trial
- Randomised controlled trial
- phase 2b
- dose-finding
- placebo-controlled
Authors' conclusion
The results of this trial indicate that in patients receiving maintenance dialysis, clazakizumab reduced inflammatory biomarkers associated with cardiovascular events.
Study context
- Population
- Adults with CVD and/or DM on maintenance dialysis with high-sensitivity C-reactive protein (hs-CRP) ≥ 2 mg l-1 at baseline
- Participants
- 32 / 32 / 32 / 31
- Comparison
- Clazakizumab vs placebo every 4 weeks
- Clazakizumab 2.5 mgn = 32
- Clazakizumab 5 mgn = 32
- Clazakizumab 10 mgn = 32
- Placebon = 31reference
- Primary endpoint
- Change from baseline in hs-CRP, expressed as geometric mean ratio
- Follow-up
- Week 12
Primary result
As reported in the abstract
hs-CRP reduction relative to placebo
- Clazakizumab 2.5 mg
- reduction 86%; P < 0.0001
- Clazakizumab 5 mg
- reduction 90%; P < 0.0001
- Clazakizumab 10 mg
- reduction 92%; P < 0.0001
Secondary outcomes
hs-CRP < 2.0 mg l-1 achieved
Fibrinogen, amyloid A, secretory phospholipase A2, lipoprotein(a), albumin · 12 weeks
- Clazakizumab reduced fibrinogen, amyloid A, secretory phospholipase A2 and lipoprotein(a), and increased mean albumin vs placebo
Safety
Sustained grade 3 or 4 thrombocytopenia or neutropenia
- No cases observed
Serious infections
- Similar frequency with placebo, clazakizumab 2.5 mg and 5 mg; numerically more frequent with clazakizumab 10 mg
Original publication
IL-6 inhibition with clazakizumab in patients receiving maintenance dialysis: a randomized phase 2b trial. Nat Med. Published 25 May 2024. doi:10.1038/s41591-024-03043-1
Summarised from the published abstract; every number is checked against it