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

In reclutamentoAccetta partecipanti ora, secondo la scheda del registro.

Contatta questo studio

In breve

Fase 2 / Fase 33110 partecipanti ricercati557 centri35 paesi

Categorie

Cardiovascolare42%Nefrologia e urologia38%Endocrino e metabolico17%Ostetricia e ginecologia4%

Registrato in 1 registro

ClinicalTrials.govNCT05485961Apri questa scheda su ClinicalTrials.govSincronizzato mese scorso

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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.

Sintesi

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.

Patologie

End Stage Kidney Disease

Idoneità

Idoneità
Sesso	Tutti
Età	18 Years – Nessun massimo
Volontari sani	No

Idoneità come riportata nel registro

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.

Idoneità in frasi semplici

I criteri di questa scheda non sono ancora stati suddivisi in affermazioni distinte. Il testo del registro qui sopra è completo ed è la versione autorevole.

Disegno dello studio

Disegno dello studio
Tipo di studio	Interventistico
Fase	Fase 2 / Fase 3
Assegnazione	Randomizzata
Modello di intervento	PARALLEL
Finalità principale	SUPPORTIVE_CARE
Mascheramento	QUADRUPLE (4)
Arruolamento	3110 partecipanti ricercati

Sponsor e collaboratori

CSL Behring Sponsor

Bracci e interventi

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

Interventi

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

Esiti misurati

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

Date

Date
Data di inizio	21 ottobre 2022 (effettiva)
Conclusione primaria	22 maggio 2029 (stimata)
Conclusione	22 maggio 2029 (stimata)
Prima pubblicazione	3 agosto 2022 (effettiva)
Ultimo aggiornamento	11 agosto 2026
Risultati pubblicati	Non indicato nella scheda del registro
Stato verificato l'ultima volta	agosto 2026

«Effettiva» significa che l'evento è avvenuto. «Stimata» significa che lo sponsor lo prevede. Le due cose non sono equivalenti.

Centri

507 centri stanno reclutando

Argentina

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

Australia

Australia
Struttura	Città	Stato o regione	Stato
Wide Bay Hospital and Health Service	Bundaberg		Ritirato
Cairns Hospital	Cairns	Queensland	In reclutamento
Monash Medical Centre	Clayton	Victoria	In reclutamento
Austin Hospital	Heidelberg		In reclutamento
Liverpool Hospital	Liverpool		In reclutamento
Fiona Stanley Hospital	Murdoch		In reclutamento
Sunshine Coast University Private Hospital	Nambour		In reclutamento
Sunshine Coast University Private Hospital	Nambour	Queensland	Sospeso
Royal Melbourne Hospital	Parkville		In reclutamento
Royal North Shore Hospital (RNSH)	Saint Leonards	New South Wales	In reclutamento
Gold Coast University Hospital	Southport		In reclutamento
Sunshine Hospital	St Albans	Victoria	In reclutamento
Concord Repatriation General Hospital	Sydney	New South Wales	In reclutamento
Fraser Coast Renal Service, Hervey Bay Hospital	Urraween		In reclutamento
Sydney Adventist Hospital	Wahroonga		In reclutamento
Westmead Hospital	Westmead		In reclutamento
Wollongong Renal Unit	Wollongong		In reclutamento
Princess Alexandra Hospital	Woolloongabba	Queensland	Sospeso

Austria

Austria
Struttura	Città	Stato o regione	Stato
Wiener Gesundheitsverbund - Klinik Hietzing	Vienna		In reclutamento

Belgium

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

Brazil

Brazil
Struttura	Città	Stato
NUPEC-Nucleo de Pesquisa Clinica	Belo Horizonte	In reclutamento
Santa Casa de Misericordia de Belo Horizonte	Belo Horizonte	In reclutamento
Hospital Universitário Walter Cantídio (Fortaleza)	Fortaleza	In reclutamento
Empresa Brasileira de Serviços Hospitalares (EBSERH)	Goiânia	In reclutamento
Fundacao Pro Rim de Santa Catarina	Joinville	In reclutamento

Nella scheda del registro sono indicati altri 507 centri.

Documenti dello studio

In questa scheda del registro non sono collegati documenti.

Modifiche nel tempo

11 agosto 2026
Centro aggiunto
9 sites added (557 total)
548557

Registro: ClinicalTrials.gov · NCT########

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