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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En resumen

Fase 2 / Fase 33110 participantes buscados557 centros35 países

Categorías

Cardiovascular42%Nefrología y urología38%Endocrino y metabólico17%Obstetricia y ginecología4%

Registrado en 1 registro

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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.

Resumen

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.

Afecciones

End Stage Kidney Disease

Elegibilidad

Elegibilidad
Sexo	Todos
Edades	18 Years – Sin máximo
Voluntarios sanos	No

Elegibilidad tal como figura en el 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.

Elegibilidad en frases sencillas

Los criterios de este registro aún no se han desglosado en frases separadas. El texto del registro anterior está completo y es la versión autorizada.

Diseño del estudio

Diseño del estudio
Tipo de estudio	De intervención
Fase	Fase 2 / Fase 3
Asignación	Aleatorizado
Modelo de intervención	PARALLEL
Propósito principal	SUPPORTIVE_CARE
Enmascaramiento	QUADRUPLE (4)
Inscripción	3110 participantes buscados

Patrocinador y colaboradores

CSL Behring Patrocinador

Grupos e intervenciones

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

Intervenciones

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

Variables de resultado

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

Fechas

Fechas
Fecha de inicio	21 de octubre de 2022 (real)
Finalización principal	22 de mayo de 2029 (estimada)
Finalización	22 de mayo de 2029 (estimada)
Primera publicación	3 de agosto de 2022 (real)
Última actualización	11 de agosto de 2026
Resultados publicados	No indicado en el registro
Estado verificado por última vez	agosto de 2026

Real significa que el evento ocurrió. Estimada significa que el patrocinador lo prevé. Ambas cosas significan algo distinto.

Ubicaciones

507 centros están en reclutamiento

Argentina

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

Australia

Australia
Centro	Ciudad	Estado o región	Estado
Wide Bay Hospital and Health Service	Bundaberg		Retirado
Cairns Hospital	Cairns	Queensland	En reclutamiento
Monash Medical Centre	Clayton	Victoria	En reclutamiento
Austin Hospital	Heidelberg		En reclutamiento
Liverpool Hospital	Liverpool		En reclutamiento
Fiona Stanley Hospital	Murdoch		En reclutamiento
Sunshine Coast University Private Hospital	Nambour		En reclutamiento
Sunshine Coast University Private Hospital	Nambour	Queensland	Suspendido
Royal Melbourne Hospital	Parkville		En reclutamiento
Royal North Shore Hospital (RNSH)	Saint Leonards	New South Wales	En reclutamiento
Gold Coast University Hospital	Southport		En reclutamiento
Sunshine Hospital	St Albans	Victoria	En reclutamiento
Concord Repatriation General Hospital	Sydney	New South Wales	En reclutamiento
Fraser Coast Renal Service, Hervey Bay Hospital	Urraween		En reclutamiento
Sydney Adventist Hospital	Wahroonga		En reclutamiento
Westmead Hospital	Westmead		En reclutamiento
Wollongong Renal Unit	Wollongong		En reclutamiento
Princess Alexandra Hospital	Woolloongabba	Queensland	Suspendido

Austria

Austria
Centro	Ciudad	Estado o región	Estado
Wiener Gesundheitsverbund - Klinik Hietzing	Vienna		En reclutamiento

Belgium

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

Brazil

Brazil
Centro	Ciudad	Estado
NUPEC-Nucleo de Pesquisa Clinica	Belo Horizonte	En reclutamiento
Santa Casa de Misericordia de Belo Horizonte	Belo Horizonte	En reclutamiento
Hospital Universitário Walter Cantídio (Fortaleza)	Fortaleza	En reclutamiento
Empresa Brasileira de Serviços Hospitalares (EBSERH)	Goiânia	En reclutamiento
Fundacao Pro Rim de Santa Catarina	Joinville	En reclutamiento

En el registro figuran 507 centros más.

Documentos del estudio

No hay documentos enlazados en este registro.

Cambios a lo largo del tiempo

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

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

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