Testing CSL300 for heart health in dialysis patients with kidney disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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.
* 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.
* 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 it's running

• Nephrology of North Alabama
  Decatur, Alabama, United States Recruiting
• Nephrology Consultants, LLC
  Huntsville, Alabama, United States Recruiting
• DaVita Clinical Research Montgomery
  Montgomery, Alabama, United States Recruiting
• AKDHC Medical
  Glendale, Arizona, United States Recruiting
• Kidney Disease Medical Group
  Glendale, Arizona, United States Recruiting
• AKDHC Medical
  Phoenix, Arizona, United States Recruiting

+516 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Trial Registration Coordinator
• Email: clinicaltrials@cslbehring.com
• Phone: +1 610-878-4697

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.