NCT05485961ClinicalTrials.gov

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

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Kurz gefasst

Phase 2 / Phase 33.110 Teilnehmende gesucht557 Studienzentren35 Länder

Kategorien

Herz-Kreislauf42%Nephrologie und Urologie38%Endokrin und metabolisch17%Geburtshilfe und Gynäkologie4%

In 1 Register registriert

ClinicalTrials.govNCT05485961Diesen Eintrag bei ClinicalTrials.gov öffnenSynchronisiert letzten Monat

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

Present: Registered before enrolment beganFirst posted 2022-08-03; recorded start 2022-10-21
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Present: Participants are randomly assignedAllocation is recorded as randomised
Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
Present: Uses blinding (masking)A masking level is recorded in the record
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Present: Sponsor has 46 other studies in this databaseCounted from the lead sponsor named in the record (CSL Behring)
Present: Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database

The record lists 1 condition.
Lead sponsor type recorded as: industry.
Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourDEFINITIVE

A definitive-grade design for a phase 3 study, judged from its ClinicalTrials.gov record.

How this score is built

Randomised allocation20/20
Participants are randomly allocated between arms
Blinding20/20
Quadruple-blind
Control arm13/15
Placebo / sham control arm
Primary-outcome specificity10/10
Named primary outcome with a defined time frame
Endpoint type3/10
Surrogate or intermediate endpoint (conservative default)
Multi-centre8/8
Multi-centre: 548 sites
Data monitoring committee7/7
A data monitoring committee is in place
Prospective registration5/5
Registered before the study start date
Protocol / SAP posted0/5
No protocol or SAP posted to the registry

ScaleLARGE

A large study, international in scope: 3,110 participants (target), run at 557 sites, across 35 countries.

How this score is built

Enrolment34/40
3,110 participants (target)
Site count25/25
548 sites
Country count15/15
33 countries
Planned duration10/10
Planned over about 80 months
Sponsor scale6/10
CSL Behring has led 47 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built

Investigator standing0/100
No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Zusammenfassung

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.

Erkrankungen

End Stage Kidney Disease

Eignung

Eignung
Geschlecht	Alle
Alter	18 Years – Kein Höchstalter
Gesunde Freiwillige	Nein

Eignung im Wortlaut des Registers

Inclusion Criteria: * 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 Criteria: * Subjects who participated in Part 1 (phase 2b) are not eligible to participate in Part 2 (phase 3). * 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 inclusion 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.

Eignung in einfachen Aussagen

Die Kriterien dieses Eintrags wurden noch nicht in einzelne Aussagen aufgeschlüsselt. Der Registertext oben ist vollständig und ist die maßgebliche Fassung.

Studiendesign

Studiendesign
Studientyp	Interventionell
Phase	Phase 2 / Phase 3
Zuteilung	Randomisiert
Interventionsmodell	PARALLEL
Primäres Ziel	SUPPORTIVE_CARE
Verblindung	QUADRUPLE (4)
Teilnahme	3.110 Teilnehmende gesucht

Sponsor und Mitwirkende

CSL Behring Sponsor

Studienarme und Interventionen

CSL300 (low dose)(Phase 2b)EXPERIMENTAL
Intravenous (IV) administration
CSL300 (medium dose)(Phase 2b)EXPERIMENTAL
IV administration
CSL300 (high dose)(Phase 2b)EXPERIMENTAL
IV administration
Placebo (Phase 2b)PLACEBO_COMPARATOR
IV administration
CSL300 (Phase 3)EXPERIMENTAL
IV administration
Placebo (Phase 3)PLACEBO_COMPARATOR
IV administration

Interventionen

Arzneimittel CSL300
IV administration
Arzneimittel Placebo
Matching the excipient content and concentration of the CSL300 product, minus the active ingredient.

Endpunkte

Primärer Endpunkt
Change from Baseline on the log scale in high-sensitivity C-reactive protein (hs-CRP)(Phase 2b)
Zeitrahmen Baseline and up to Week 12
Primärer Endpunkt
Time to first occurrence of CV death or myocardial infarction (MI) (Phase 3)
Zeitrahmen Approximately 5 years
Sekundärer Endpunkt
Mean change from Baseline in iron (Phase 2b)
Zeitrahmen Baseline and up to Week 12
Sekundärer Endpunkt
Area under the plasma concentration versus time curve (AUC) for CSL300 (Phase 2b)
Zeitrahmen Up to Week 24
Sekundärer Endpunkt
Mean change from Baseline in total iron binding capacity (TIBC) (Phase 2b)
Zeitrahmen Baseline and up to Week 12
Sekundärer Endpunkt
Mean change from Baseline in transferrin saturation (TSAT) (Phase 2b)
Zeitrahmen Baseline and up to Week 12
Sekundärer Endpunkt
Mean change from Baseline in ferritin (Phase 2b)
Zeitrahmen Baseline and up to Week 12
Sekundärer Endpunkt
Mean change from Baseline in Hepcidin (Phase 2b)
Zeitrahmen Baseline and up to Week 12
Sekundärer Endpunkt
Mean change from Baseline in hemoglobin (Phase 2b)
Zeitrahmen Baseline and up to Week 12
Sekundärer Endpunkt
Mean change from Baseline in erythropoiesis-stimulating agents (ESA) (Phase 2b)
Zeitrahmen Baseline and up to Week 12
Sekundärer Endpunkt
Mean change from Baseline in erythropoietin-resistance index (ERI) (Phase 2b)
Zeitrahmen Baseline and up to Week 12
Sekundärer Endpunkt
Percent of participants achieving hs-CRP less than (<) 2.0 milligram per Liter (mg/L) (Phase 2b)
Zeitrahmen Week 12
Sekundärer Endpunkt
Change from baseline in log-transformed hs-CRP (Phase 2b)
Zeitrahmen Baseline and up to Week 24
Sekundärer Endpunkt
Mean change from Baseline in serum amyloid A (SAA) (Phase 2b)
Zeitrahmen Baseline and up to Week 12
Sekundärer Endpunkt
Mean change from Baseline in secretory phospholipase A2 (sPLA2) (Phase 2b)
Zeitrahmen Baseline and up to Week 12
Sekundärer Endpunkt
Mean change from Baseline in fibrinogen (Phase 2b)
Zeitrahmen Baseline and up to Week 12
Sekundärer Endpunkt
Mean change from Baseline in plasminogen activator inhibitor -1 (PAI-1) (Phase 2b)
Zeitrahmen Baseline and up to Week 12
Sekundärer Endpunkt
Mean change from Baseline in lipoprotein (Lp) (a) (Phase 2b)
Zeitrahmen Baseline and up to Week 12
Sekundärer Endpunkt
Mean change from Baseline in albumin (Phase 2b)
Zeitrahmen Baseline and up to Week 12
Sekundärer Endpunkt
Peak Plasma Concentration (Cmax) for CSL300 (Phase 2b)
Zeitrahmen Up to Week 24
Sekundärer Endpunkt
Trough Plasma Concentration (Ctrough) for CSL300 (Phase 2b)
Zeitrahmen Up to Week 24
Sekundärer Endpunkt
Time to Maximum Plasma Concentration (Tmax) for CSL300 (Phase 2b)
Zeitrahmen Up to Week 24
Sekundärer Endpunkt
Percent of participants with adverse events (AE), serious AE (SAE), including adverse events of special interest (AESIs) (Phase 2b)
Zeitrahmen Up to Week 32
Sekundärer Endpunkt
Mean change from Baseline in white blood cell (WBC) (Phase 2b)
Zeitrahmen Up to Week 12
Sekundärer Endpunkt
Mean change from Baseline in neutrophils (Phase 2b)
Zeitrahmen Up to Week 12
Sekundärer Endpunkt
Mean change from Baseline in platelets (Phase 2b)
Zeitrahmen Up to Week 12
Sekundärer Endpunkt
Mean change from Baseline in aspartate aminotransferase (AST) (Phase 2b)
Zeitrahmen Up to Week 12
Sekundärer Endpunkt
Mean change from Baseline in alanine aminotransferase (ALT) (Phase 2b)
Zeitrahmen Up to Week 12
Sekundärer Endpunkt
Mean change from Baseline in total bilirubin (Phase 2b)
Zeitrahmen Up to Week 12
Sekundärer Endpunkt
Mean change from Baseline in lipid panel (Phase 2b)
Lipid panel consists of total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), triglyceride.
Zeitrahmen Up to Week 12
Sekundärer Endpunkt
Titer of confirmed antibodies specific to CSL300 (Phase 2b)
Zeitrahmen Up to Week 12
Sekundärer Endpunkt
Time to first occurrence of all-cause death or MI (Phase 3)
Zeitrahmen Approximately 5 years
Sekundärer Endpunkt
Time to first occurrence of CV death, MI, or ischemic stroke (Phase 3)
Zeitrahmen Approximately 5 years
Sekundärer Endpunkt
Time to first occurrence of CV death (Phase 3)
Zeitrahmen Approximately 5 years
Sekundärer Endpunkt
Time to first occurrence of CV death, MI or major adverse limb event (Phase 3)
Zeitrahmen Approximately 5 years
Sekundärer Endpunkt
Time to first occurrence of all-cause death (Phase 3)
Zeitrahmen Approximately 5 years
Sekundärer Endpunkt
Time to first occurrence of CV death, MI, or hospitalization for heart failure (HF) (Phase 3)
Zeitrahmen Up to 5 years
Sekundärer Endpunkt
Total number of CV hospitalizations (Phase 3)
Zeitrahmen Approximately 5 years
Sekundärer Endpunkt
Total number of HF hospitalizations and urgent visits (Phase 3)
Zeitrahmen Approximately 5 years
Sekundärer Endpunkt
Total number of hospitalizations (Phase 3)
Zeitrahmen Approximately 5 years

Daten

Daten
Startdatum	21. Oktober 2022 (tatsächlich)
Primärer Abschluss	22. Mai 2029 (geschätzt)
Abschluss	22. Mai 2029 (geschätzt)
Erstveröffentlichung	3. August 2022 (tatsächlich)
Zuletzt aktualisiert	11. August 2026
Ergebnisse veröffentlicht	Im Registereintrag nicht angegeben
Status zuletzt bestätigt	August 2026

Tatsächlich bedeutet, dass das Ereignis eingetreten ist. Geschätzt bedeutet, dass der Sponsor es erwartet. Die beiden bedeuten Unterschiedliches.

Standorte

507 Studienzentren rekrutieren

Argentina

Argentina
Einrichtung	Stadt	Status
FME Lomas de Zamora	Banfield	Rekrutiert
FME Mansilla	Buenos Aires	Rekrutiert
Instituto de Trasplante De La Ciudad Autonoma De Buenos Aires	Buenos Aires	Rekrutiert
FME Avellaneda	Buenos Aires	Rekrutiert
FME Cemic Saavedra	Ciudad Autonoma	Rekrutiert
Fresenius Medical Care - Ciudad Evita	Ciudad Evita	Rekrutiert
CEREHA	Ciudad de Buenos Aires	Rekrutiert
Clinica Privada Velez Sarsfield	Córdoba	Rekrutiert
FME Formosa	Formosa	Rekrutiert
STR Hurlingham SRL	Hurlingham	Rekrutiert
Nextdial S.A.	Mar del Plata	Rekrutiert
Fresenius Medical Care - Nostri Centri Dialisi - Moron	Morón	Rekrutiert
Instituto Medico de la Fundacion de Estudios Clínicos	Rosario	Rekrutiert
FME San Fernando	San Fernando	Rekrutiert
Fresenius Tucumán	San Miguel de Tucumán	Rekrutiert
Clínica de Nefrología, Urología y Enfermedades Cardiovasculares	Santa Fe	Rekrutiert

Australia

Australia
Einrichtung	Stadt	Bundesland oder Region	Status
Wide Bay Hospital and Health Service	Bundaberg		Zurückgezogen
Cairns Hospital	Cairns	Queensland	Rekrutiert
Monash Medical Centre	Clayton	Victoria	Rekrutiert
Austin Hospital	Heidelberg		Rekrutiert
Liverpool Hospital	Liverpool		Rekrutiert
Fiona Stanley Hospital	Murdoch		Rekrutiert
Sunshine Coast University Private Hospital	Nambour		Rekrutiert
Sunshine Coast University Private Hospital	Nambour	Queensland	Ausgesetzt
Royal Melbourne Hospital	Parkville		Rekrutiert
Royal North Shore Hospital (RNSH)	Saint Leonards	New South Wales	Rekrutiert
Gold Coast University Hospital	Southport		Rekrutiert
Sunshine Hospital	St Albans	Victoria	Rekrutiert
Concord Repatriation General Hospital	Sydney	New South Wales	Rekrutiert
Fraser Coast Renal Service, Hervey Bay Hospital	Urraween		Rekrutiert
Sydney Adventist Hospital	Wahroonga		Rekrutiert
Westmead Hospital	Westmead		Rekrutiert
Wollongong Renal Unit	Wollongong		Rekrutiert
Princess Alexandra Hospital	Woolloongabba	Queensland	Ausgesetzt

Austria

Austria
Einrichtung	Stadt	Bundesland oder Region	Status
Wiener Gesundheitsverbund - Klinik Hietzing	Vienna		Rekrutiert

Belgium

Belgium
Einrichtung	Stadt	Status
Onze-Lieve-Vrouwziekenhuis VZW	Aalst	Rekrutiert
Imelda Ziekenhuis	Bonheiden	Rekrutiert
Centre Hospitalier Universitaire (CHU) de Charleroi - Hopital Civil Marie Curie	Charleroi	Rekrutiert
AZ Sint-Lucas	Ghent	Ausgesetzt
Centre Hospitalier Universitaire de Tivoli	La Louvière	Rekrutiert
Jan Yperman Ziekenhuis	Leper	Rekrutiert
Universitair Ziekenhuis Leuven	Leuven	Rekrutiert
CHR de la Citadelle	Liège	Rekrutiert
AZ Delta (H.-Hartziekenhuis Roeselare-Menen vzw (HHRM)) - Campus Rumbeke	Roeselare	Rekrutiert
VITAZ, Department Nierziekten & Dialyse	Sint-Niklaas	Rekrutiert

Brazil

Brazil
Einrichtung	Stadt	Status
NUPEC-Nucleo de Pesquisa Clinica	Belo Horizonte	Rekrutiert
Santa Casa de Misericordia de Belo Horizonte	Belo Horizonte	Rekrutiert
Hospital Universitário Walter Cantídio (Fortaleza)	Fortaleza	Rekrutiert
Empresa Brasileira de Serviços Hospitalares (EBSERH)	Goiânia	Rekrutiert
Fundacao Pro Rim de Santa Catarina	Joinville	Rekrutiert

507 weitere Studienzentren sind im Registereintrag aufgeführt.

Studiendokumente

In diesem Registereintrag sind keine Dokumente verlinkt.

Änderungen im Zeitverlauf

11. August 2026
Studienzentrum hinzugefügt
9 sites added (557 total)
548557

https://xmedica.io/trials/ctgov/NCT05485961