Testing CSL300 against a placebo for end stage kidney disease
Official title: Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD Undergoing Dialysis (POSIBIL6ESKD)
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 (Clazakizumab) in Subjects With End Stage Kidney Disease Undergoing Dialysis
- Phase 2
- 6 groups
- Sites in Longueuil, Montreal and 11 more cities
- Recruiting
Interventions
- Medication
CSL300
IV administration
- Medication
Placebo
Matching the excipient content and concentration of the CSL300 product, minus the active ingredient.
Canadian Sites (16)
15 of 16 recruiting
- Recruiting
University of Alberta Hospital
Edmonton, Alberta
- Recruiting
Maisonneuve-Rosemont Hospital
Montreal
- Recruiting
CHUM - Centre hospitalier de l'Universite de Montreal
Montreal
- Recruiting
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia
- Recruiting
St. Josephs Healthcare Hamilton
Hamilton, Ontario
- Recruiting
Kingston Health Sciences Centre
Kingston, Ontario
- Recruiting
London Health Sciences Centre - University Hospital
London, Ontario
- Recruiting
Lakeridge Health Oshawa
Oshawa, Ontario
- Recruiting
The Ottawa Hospital Research Institute
Ottawa
- Recruiting
McGill University Health Centre
Montreal, Quebec
- Recruiting
Hôpital du Sacré-Cœur-de-Montréal
Montreal, Quebec
- Recruiting
Ciussse-Chus
Sherbrooke
- Recruiting
St. Michaels Hospital
Toronto
- Recruiting
St Paul Hospital
Vancouver
- Recruiting
Seven Oaks Hospital
Winnipeg
- Withdrawn
Hospital Charles Lemoyne
Longueuil
Eligibility Criteria
See who this study is looking for11 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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
- −Subjects who participated in Part 1 (phase 2b) are not eligible to participate in Part 2 (phase 3Phase 3A large study comparing a treatment against the current standard.Read more →).
- −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 inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → 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.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a way to improve comfort and quality of life alongside other care.
Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more →/3 — a combined study that runs the middle stage and the large comparison stage together.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 6 groups in this study.
Groups A, B, C and E receive CSL300.
Registry label: A: CSL300 (low dose)(Phase 2b) · B: CSL300 (medium dose)(Phase 2b) · C: CSL300 (high dose)(Phase 2b) · E: CSL300 (Phase 3)
Groups D and F, the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group, receive Placebo.
Registry label: D: Placebo (Phase 2b) · F: Placebo (Phase 3)
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 3,110 people.
The study is currently expected to finish around May 2029.
The main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more → and up to Week 12.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Change from BaselineBaselineYour starting measurements, taken before treatment begins.Read more → on the log scale in high-sensitivity C-reactive protein (hs-CRP)(Phase 2b) — measured over Baseline and up to Week 12.
Time to first occurrence of CV death or myocardial infarction (MI) (Phase 3Phase 3A large study comparing a treatment against the current standard.Read more →) — measured over Approximately 5 years.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05485961 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About CSL300Drug
IV administration
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PlaceboDrug
Matching the excipient content and concentration of the CSL300 product, minus the active ingredient.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more → and up to Week 12.
The study as a whole is currently expected to finish around 2029-05-22.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 3,110 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 24 locations, including: Longueuil, Canada; Montreal, Canada; Ottawa, Canada; Sherbrooke, Canada; Toronto, Canada; Vancouver, Canada, and 18 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
This is a two-part, phase 2b and phase 3 combined 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 vs placebo 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.
Other Sites (14)
Paragon Health, Inc
Kalamazoo, Michigan, United States
Michigan Kidney Consultants, PC
Pontiac, Michigan, United States
St. Clair Nephrology Research
Roseville, Michigan, United States
Center for Advanced Kidney Research, PLC
Saint Clair Shores, Michigan, United States
DCR Edina
Minneapolis, Minnesota, United States
DCR Edina
Minneapolis, Minnesota, United States
Minneapolis VA Health Care System
Minneapolis, Minnesota, United States
Albany Medical College Committee of Research Involving Human Subjects
Albany, New York, United States
SUNY Downstate Medical Center Brooklyn
Brooklyn, New York, United States
Mattoo & Bhat Medical Associates, P.C.
College Point, New York, United States
NYU Langone Hospital - Long Island
Mineola, New York, United States
DaVita Clinic Research Bronx
The Bronx, New York, United States
Albert Einstein College of Medicine - Montefiore Medical Center
The Bronx, New York, United States
James J Peters VA Medical Center
The Bronx, New York, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.