Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD Undergoing Dialysis
NCT05485961 · View on ClinicalTrials.gov ↗
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 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical 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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 2,310 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is CSL Behring, which has 85 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05485961 reports 20 study locations spanning 3 distinct geographic areas — top geographies include California, Arizona, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05485961?
The interventions under investigation include: Placebo (DRUG), CSL300 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05485961?
This trial is sponsored by CSL Behring, which has 85 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.