Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT05485961 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Atherosclerotic Cardiovascular Disease and End-Stage Kidney Disease, sponsored by CSL Behring.

Recruiting
Registry status
Phase 2
Development phase
2,310
Enrollment target
20
Study locations

NCT05485961 is a Phase 2 study of Atherosclerotic Cardiovascular Disease and End-Stage Kidney Disease that is actively recruiting participants, run by CSL Behring. The registered enrollment target is 2,310 participants, below the 7,458-participant average among 21 other Atherosclerotic Cardiovascular Disease trials with a reported enrollment target (69% lower). The trial reports 20 study locations across 3 states.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT05485961, a Phase 2 study of Atherosclerotic Cardiovascular Disease and End-Stage Kidney Disease, is actively recruiting participants, sponsored by CSL Behring.

RECRUITING
Registry status
Phase 2
Development phase
2,310 participants
Enrollment target
20
Study locations

Study Summary

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.

Conditions Studied

Atherosclerotic Cardiovascular Disease End-Stage Kidney Disease Atherosclerotic Cardiovascular Disease in Patients With ESKD

Interventions

  • DRUG Placebo
  • DRUG CSL300

Study Locations (20)

California

  • National Institute of Clinical Research - Bakersfield
  • Amicis Research Center - Beverly Hills
  • California Institute of Renal Research - Chula Vista
  • The Medical Research Group, Inc. - Fresno
  • Davita Fullerton Dialysis Center - Fullerton
  • National Institute of Clinical Research, Inc. - Fullerton
  • National Institute of Clinical Research, Inc. - Garden Grove
  • St. Jude Medical Center - Garden Grove
  • National Institute of Clinical Research - Garden Grove
  • Sherman Medical Group, Inc - Glendale
  • Kidney Disease Medical Group - Glendale
  • Renal Consultants Medical Group - Granada Hills

Arizona

  • AKDHC Medical - Glendale
  • Kidney Disease Medical Group - Glendale
  • AKDHC Medical - Phoenix
  • AKDHC Medical - Tucson
  • Southern Arizona VA Health Care System - Tucson

Alabama

  • Nephrology of North Alabama - Decatur
  • Nephrology Consultants, LLC - Huntsville
  • DaVita Clinical Research Montgomery - Montgomery

Trial Details

FieldValue
Enrollment Target 2,310 participants
Start Date 2022-10-21
Est. Completion 2029-09-27
Phase Phase 2

Sponsor

CSL Behring

71 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05485961

The ClinicalTrials.gov registry entry for NCT05485961 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 2,310 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 7,458-participant average among 21 other Atherosclerotic Cardiovascular Disease trials with a reported enrollment target (69% lower). The listed sponsor is CSL Behring, which has 71 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Atherosclerotic Cardiovascular Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT05485961 reports 20 study locations spanning 3 distinct geographic areas - top geographies include California, Arizona, Alabama.

Frequently Asked Questions

What is clinical trial NCT05485961 about?

NCT05485961 is a clinical study titled "Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD Undergoing Dialysis". 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 w...

What is the current status of trial NCT05485961?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 2,310 participants. The study started on 2022-10-21. Estimated completion is 2029-09-27.

What conditions does trial NCT05485961 study?

This clinical trial studies the following conditions: Atherosclerotic Cardiovascular Disease, End-Stage Kidney Disease, Atherosclerotic Cardiovascular Disease in Patients With ESKD.

What interventions are being tested in trial NCT05485961?

The interventions under investigation include: Placebo (DRUG), CSL300 (DRUG).

Who is sponsoring clinical trial NCT05485961?

This trial is sponsored by CSL Behring, which has 71 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05485961 being conducted?

This trial has 20 study locations across Alabama, Arizona, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Atherosclerotic Cardiovascular Disease

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Explore more on PlainTrial

Atherosclerotic Cardiovascular Disease

All registered trials for this condition

End-Stage Kidney Disease

All registered trials for this condition

Alabama

All trials with a study site in Alabama

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.