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Testing CSL300 for heart health in dialysis patients with kidney disease

A Phase 2b / 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Combined Dose-Finding and Cardiovascular Outcome Study to Investigate the Efficacy and Safety of CSL300 (Clazakizumab) in Subjects With End Stage Kidney Disease Undergoing Dialysis

Phase2; Phase3 Interventional CSL Behring · NCT05485961

This study is testing if a new treatment called CSL300 can improve heart health in dialysis patients with kidney disease and related conditions like diabetes or heart disease.

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Enrollment2310 (estimated)
Ages18 Years and up
SexAll
SponsorCSL Behring Industry-sponsored
Locations542 sites (Decatur, Alabama and 541 other locations)
Trial IDNCT05485961 on ClinicalTrials.gov

What this trial studies

This is a two-part, multicenter, randomized, double-blind, placebo-controlled study evaluating CSL300 in adults with end-stage kidney disease (ESKD) undergoing dialysis. The first part focuses on determining the appropriate dosage of CSL300, while the second part assesses its efficacy on cardiovascular outcomes and safety in patients with systemic inflammation and either atherosclerotic cardiovascular disease or diabetes. Participants will receive either CSL300 or a placebo to compare effects on heart health.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with ESKD on maintenance dialysis for at least 12 weeks and elevated serum hs-CRP levels.

Not a fit: Patients with life-threatening diseases expected to result in death within 12 months or those on systemic immunosuppressants may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve cardiovascular health outcomes for patients with ESKD undergoing dialysis.

How similar studies have performed: Other studies have explored similar interventions in cardiovascular health for kidney disease patients, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* \- 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

Exclusion Criteria:

* \- Subjects who participated in Part 1 (phase 2b) are not eligible to participate in Part 2 (phase 3)
* \- Concomitant use of systemic immunosuppressant drugs
* \- Abnormal LFTs
* \- Any life-threatening disease expected to result in death within 12 months
* \- A history of GI perforation, inflammatory bowel disease (except fully excised ulcerative colitis), or peptic ulcer disease
* -Clinically significant active infection or history of opportunistic or invasive fungal infection

Where this trial is running

Decatur, Alabama and 541 other locations

+492 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Atherosclerotic Cardiovascular DiseaseEnd Stage Kidney DiseaseAtherosclerotic Cardiovascular Disease in Patients With ESKDMyocardial infarctionAtherosclerotic cardiovascular diseaseCoronary artery diseasePeripheral artery diseaseDiabetes
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.