IL-6 inhibition with clazakizumab in patients receiving maintenance dialysis: a randomized phase 2b trial
An erratum to this article was published (Nat Med, Aug 2024 ↗)
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
Methodological detailsphase 2b, dose-finding, placebo-controlled
- Phase 2b
- Dose-finding
- Placebo-controlled
Primary result
As reported in the abstract
hs-CRP reduction relative to placebo
Reduction
86%
P < 0.0001
Clazakizumab 2.5 mg
Reduction
90%
P < 0.0001
Clazakizumab 5 mg
Reduction
92%
P < 0.0001
Clazakizumab 10 mg
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.
Summarised from the published abstract; every number is checked against it