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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: Recruiting Phase 2 study of Atherosclerotic Cardiovascular Disease and End-Stage Kidney Disease, sponsored by CSL Behring.
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. According to ClinicalTrials.gov, the official US trial registry.
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
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
| Field | Value |
|---|---|
| Enrollment Target | 2,310 participants |
| Start Date | 2022-10-21 |
| Est. Completion | 2029-09-27 |
| Phase | Phase 2 |
What NCT05485961 shows while recruiting
NCT05485961 is an interventional study that assigns participants to a tested intervention. Its 2,310 participants enrollment target places it among the larger protocols in the corpus, below the 7,458-participant average among 21 other Atherosclerotic Cardiovascular Disease trials with a reported enrollment target (69% lower).
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 names 20 study sites across 3 states, led by 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
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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.
Where NCT05485961's enrollment target sits among peer trials
2,310 8th of 21 higher than 14 of 21 other Atherosclerotic Cardiovascular Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Atherosclerotic Cardiovascular Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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