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

Conditions

• Atherosclerotic Cardiovascular Disease in Patients With ESKD

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• CSL300 — DRUG
  IV administration
• Placebo — DRUG
  Matching the excipient content and concentration of the CSL300 product, minus the active ingredient.

Study Details

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.

Key Dates

Start date

Oct 21, 2022

Status verified

Jun 2026

Primary completion

May 22, 2029

Completion

May 22, 2029

Study Design

Enrollment

3,110 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Arms

• Experimental: CSL300 (low dose)(Phase 2b)
  Intravenous (IV) administration
• Experimental: CSL300 (medium dose)(Phase 2b)
  IV administration
• Experimental: CSL300 (high dose)(Phase 2b)
  IV administration
• Placebo Comparator: Placebo (Phase 2b)
  IV administration
• Experimental: CSL300 (Phase 3)
  IV administration
• Placebo Comparator: Placebo (Phase 3)
  IV administration

Primary Outcome Measure

Change from Baseline on the log scale in high-sensitivity C-reactive protein (hs-CRP)(Phase 2b) [ Time Frame: Baseline and up to 12 weeks ]

Central Contacts

• Trial Registration Coordinator
  +1 610-878-4697
  [email protected]

Locations (164)

Find similar trials in Decatur, AL