ClinicaliQ Trial Snapshot
- Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD Undergoing Dialysis — Recruiting • Phase II • Cardiology / Cardiovascular • NCT05485961.
- What is being tested: CSL300 (clazakizumab), an IL-6 pathway inhibitor, is being evaluated in a two-part trial to identify optimal dosing (phase 2b) and then assess its effect on cardiovascular outcomes (phase 3) in dialysis patients with end-stage kidney disease.
- Patient eligibility overview: The trial enrolls adult subjects with ESKD who are currently undergoing dialysis treatment and meet specified cardiovascular risk criteria for the outcomes phase.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
This is a 2-part (phase 2b/3) 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 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 Snapshot
- : * - 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
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.