CSL300 (Clazakizumab) in Subjects with End Stage Kidney Disease

What is the Purpose of this Study?

Primary Objective: To evaluate the efficacy on hs-CRP reduction of different intravenous doses of CSL300 administered every 4 weeks. Primary Endpoint: The change from Baseline on the log scale in hs-CRP to Week 12.


Eligibility

  • * \- 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
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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

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 in Subjects with End Stage Kidney Disease Undergoing Dialysis

Study Details
Disease Type/Condition

Other

Principal Investigator

Karumanchi, Subbian

Co-Investigators

Sanjeev Kumar

Age Group

Adult

Phase

II/III

IRB Number

STUDY00003357

ClinicalTrials.gov ID

NCT05485961

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Email
clinicaltrials@cshs.org
Study Detail
Disease Type/Condition

Other

Principal Investigator

Karumanchi, Subbian

Age Group

Adult

Phase

II/III

IRB Number

CSL300-2301

ClinicalTrials.gov ID

NCT05485961

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org