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

ConditionEnd Stage Kidney Disease
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorCSL Behring

About this trial

This is a two-part, phase 2b and phase 3 combined prospective, interventional, multicenter, randomized, double-blind, placebo-controlled study.

Part 1: Phase 2b is a dose-finding study for CSL300 vs placebo. Part 2: Phase 3 aims to assess the efficacy of CSL300 vs placebo on cardiovascular (CV) outcomes and safety in subjects with systemic inflammation and either atherosclerotic cardiovascular disease (ASCVD) or diabetes with end stage kidney disease (ESKD) undergoing maintenance dialysis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female at least 18 years of age.

A diagnosis of ESKD undergoing maintenance dialysis for at least 12 weeks.

Serum hs-CRP ≥ 2.0 mg/L.

A diagnosis of diabetes mellitus OR ASCVD.

Disqualifiers

Subjects who participated in Part 1 (phase 2b) are not eligible to participate in Part 2 (phase 3).

Concomitant use of systemic immunosuppressant drugs.

Part 1 (Phase 2b) excludes subjects with a positive TB or a history of latent TB, whereas Part 2 (Phase 3) excludes active TB but allows inclusion of subjects with a latent TB and at least 4 weeks of prophylactic TB treatment.

Abnormal LFTs.

Trial design

Design model

Parallel

Treatments tested in this trial

  • CSL300

    Drug

    IV administration

  • Placebo

    Drug

    Matching the excipient content and concentration of the CSL300 product, minus the active ingredient.

Treatment groups

3,110 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: CSL300 (low dose)(Phase 2b)Experimental treatment 1 intervention
Group B: CSL300 (medium dose)(Phase 2b)Experimental treatment 1 intervention
Group C: CSL300 (high dose)(Phase 2b)Experimental treatment 1 intervention
Group D: Placebo (Phase 2b)Placebo comparator 1 intervention
Group E: CSL300 (Phase 3)Experimental treatment 1 intervention
Group F: Placebo (Phase 3)Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from Baseline on the log scale in high-sensitivity C-reactive protein (hs-CRP)(Phase 2b)

Time frame
Baseline and up to Week 12
2

Time to first occurrence of CV death or myocardial infarction (MI) (Phase 3)

Time frame
Approximately 5 years

Secondary outcomes

1

Percent of participants achieving hs-CRP less than (<) 2.0 milligram per Liter (mg/L) (Phase 2b)

Time frame
Week 12
2

Change from baseline in log-transformed hs-CRP (Phase 2b)

Time frame
Baseline and up to Week 24
3

Mean change from Baseline in serum amyloid A (SAA) (Phase 2b)

Time frame
Baseline and up to Week 12
4

Mean change from Baseline in secretory phospholipase A2 (sPLA2) (Phase 2b)

Time frame
Baseline and up to Week 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

CSL Behring

Lead sponsor

Source ClinicalTrials.gov
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