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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

En recrutementAccepte des participants actuellement, selon la fiche du registre.
Contacter cette étude

En bref

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…

Phase 2 / Phase 33 110 participants recherchés557 sites35 pays

Catégories

Cardiovasculaire42%Néphrologie et urologie38%Endocrinien et métabolique17%Obstétrique et gynécologie4%

Enregistré dans 1 registre

Une même étude peut être enregistrée dans plusieurs registres. Nous l'affichons une seule fois et renvoyons vers chaque fiche que nous détenons.

Les informations de l'essai sont affichées telles que publiées par le registre, dans leur langue d'origine.

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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.

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

Résumé

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.

Affections

  • End Stage Kidney Disease

Éligibilité

SexeTous
Âges18 Years – Aucun maximum
Volontaires sainsNon

Éligibilité telle qu'elle figure dans le registre

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.

Éligibilité en énoncés simples

Les critères de cette fiche n'ont pas encore été décomposés en énoncés distincts. Le texte du registre ci-dessus est complet et fait foi.

Conception de l'étude

Type d'étudeInterventionnelle
PhasePhase 2 / Phase 3
RépartitionRandomisée
Modèle d'interventionPARALLEL
Objectif principalSUPPORTIVE_CARE
InsuQUADRUPLE (4)
Recrutement3 110 participants recherchés

Promoteur et collaborateurs

  • CSL Behring Promoteur

Groupes et interventions

  • 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

Interventions

  • Médicament CSL300

    IV administration

  • Médicament Placebo

    Matching the excipient content and concentration of the CSL300 product, minus the active ingredient.

Critères de jugement

  1. Critère de jugement principal

    Change from Baseline on the log scale in high-sensitivity C-reactive protein (hs-CRP)(Phase 2b)

    Délai Baseline and up to Week 12

  2. Critère de jugement principal

    Time to first occurrence of CV death or myocardial infarction (MI) (Phase 3)

    Délai Approximately 5 years

  3. Critère de jugement secondaire

    Mean change from Baseline in iron (Phase 2b)

    Délai Baseline and up to Week 12

  4. Critère de jugement secondaire

    Area under the plasma concentration versus time curve (AUC) for CSL300 (Phase 2b)

    Délai Up to Week 24

  5. Critère de jugement secondaire

    Mean change from Baseline in total iron binding capacity (TIBC) (Phase 2b)

    Délai Baseline and up to Week 12

  6. Critère de jugement secondaire

    Mean change from Baseline in transferrin saturation (TSAT) (Phase 2b)

    Délai Baseline and up to Week 12

  7. Critère de jugement secondaire

    Mean change from Baseline in ferritin (Phase 2b)

    Délai Baseline and up to Week 12

  8. Critère de jugement secondaire

    Mean change from Baseline in Hepcidin (Phase 2b)

    Délai Baseline and up to Week 12

  9. Critère de jugement secondaire

    Mean change from Baseline in hemoglobin (Phase 2b)

    Délai Baseline and up to Week 12

  10. Critère de jugement secondaire

    Mean change from Baseline in erythropoiesis-stimulating agents (ESA) (Phase 2b)

    Délai Baseline and up to Week 12

  11. Critère de jugement secondaire

    Mean change from Baseline in erythropoietin-resistance index (ERI) (Phase 2b)

    Délai Baseline and up to Week 12

  12. Critère de jugement secondaire

    Percent of participants achieving hs-CRP less than (<) 2.0 milligram per Liter (mg/L) (Phase 2b)

    Délai Week 12

  13. Critère de jugement secondaire

    Change from baseline in log-transformed hs-CRP (Phase 2b)

    Délai Baseline and up to Week 24

  14. Critère de jugement secondaire

    Mean change from Baseline in serum amyloid A (SAA) (Phase 2b)

    Délai Baseline and up to Week 12

  15. Critère de jugement secondaire

    Mean change from Baseline in secretory phospholipase A2 (sPLA2) (Phase 2b)

    Délai Baseline and up to Week 12

  16. Critère de jugement secondaire

    Mean change from Baseline in fibrinogen (Phase 2b)

    Délai Baseline and up to Week 12

  17. Critère de jugement secondaire

    Mean change from Baseline in plasminogen activator inhibitor -1 (PAI-1) (Phase 2b)

    Délai Baseline and up to Week 12

  18. Critère de jugement secondaire

    Mean change from Baseline in lipoprotein (Lp) (a) (Phase 2b)

    Délai Baseline and up to Week 12

  19. Critère de jugement secondaire

    Mean change from Baseline in albumin (Phase 2b)

    Délai Baseline and up to Week 12

  20. Critère de jugement secondaire

    Peak Plasma Concentration (Cmax) for CSL300 (Phase 2b)

    Délai Up to Week 24

  21. Critère de jugement secondaire

    Trough Plasma Concentration (Ctrough) for CSL300 (Phase 2b)

    Délai Up to Week 24

  22. Critère de jugement secondaire

    Time to Maximum Plasma Concentration (Tmax) for CSL300 (Phase 2b)

    Délai Up to Week 24

  23. Critère de jugement secondaire

    Percent of participants with adverse events (AE), serious AE (SAE), including adverse events of special interest (AESIs) (Phase 2b)

    Délai Up to Week 32

  24. Critère de jugement secondaire

    Mean change from Baseline in white blood cell (WBC) (Phase 2b)

    Délai Up to Week 12

  25. Critère de jugement secondaire

    Mean change from Baseline in neutrophils (Phase 2b)

    Délai Up to Week 12

  26. Critère de jugement secondaire

    Mean change from Baseline in platelets (Phase 2b)

    Délai Up to Week 12

  27. Critère de jugement secondaire

    Mean change from Baseline in aspartate aminotransferase (AST) (Phase 2b)

    Délai Up to Week 12

  28. Critère de jugement secondaire

    Mean change from Baseline in alanine aminotransferase (ALT) (Phase 2b)

    Délai Up to Week 12

  29. Critère de jugement secondaire

    Mean change from Baseline in total bilirubin (Phase 2b)

    Délai Up to Week 12

  30. Critère de jugement secondaire

    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.

    Délai Up to Week 12

  31. Critère de jugement secondaire

    Titer of confirmed antibodies specific to CSL300 (Phase 2b)

    Délai Up to Week 12

  32. Critère de jugement secondaire

    Time to first occurrence of all-cause death or MI (Phase 3)

    Délai Approximately 5 years

  33. Critère de jugement secondaire

    Time to first occurrence of CV death, MI, or ischemic stroke (Phase 3)

    Délai Approximately 5 years

  34. Critère de jugement secondaire

    Time to first occurrence of CV death (Phase 3)

    Délai Approximately 5 years

  35. Critère de jugement secondaire

    Time to first occurrence of CV death, MI or major adverse limb event (Phase 3)

    Délai Approximately 5 years

  36. Critère de jugement secondaire

    Time to first occurrence of all-cause death (Phase 3)

    Délai Approximately 5 years

  37. Critère de jugement secondaire

    Time to first occurrence of CV death, MI, or hospitalization for heart failure (HF) (Phase 3)

    Délai Up to 5 years

  38. Critère de jugement secondaire

    Total number of CV hospitalizations (Phase 3)

    Délai Approximately 5 years

  39. Critère de jugement secondaire

    Total number of HF hospitalizations and urgent visits (Phase 3)

    Délai Approximately 5 years

  40. Critère de jugement secondaire

    Total number of hospitalizations (Phase 3)

    Délai Approximately 5 years

Dates

Date de début21 octobre 2022 (réelle)
Achèvement principal22 mai 2029 (estimée)
Achèvement22 mai 2029 (estimée)
Première publication3 août 2022 (réelle)
Dernière mise à jour11 août 2026
Résultats publiésNon précisé dans la fiche du registre
Statut vérifié pour la dernière foisaoût 2026

Réelle signifie que l'événement a eu lieu. Estimée signifie que le promoteur s'y attend. Les deux ont un sens différent.

Lieux

507 sites sont en recrutement

Argentina

ÉtablissementVilleÉtat ou régionStatut
FME Lomas de ZamoraBanfieldEn recrutement
FME MansillaBuenos AiresEn recrutement
Instituto de Trasplante De La Ciudad Autonoma De Buenos AiresBuenos AiresEn recrutement
FME AvellanedaBuenos AiresEn recrutement
FME Cemic SaavedraCiudad AutonomaEn recrutement
Fresenius Medical Care - Ciudad EvitaCiudad EvitaEn recrutement
CEREHACiudad de Buenos AiresEn recrutement
Clinica Privada Velez SarsfieldCórdobaEn recrutement
FME FormosaFormosaEn recrutement
STR Hurlingham SRLHurlinghamEn recrutement
Nextdial S.A.Mar del PlataEn recrutement
Fresenius Medical Care - Nostri Centri Dialisi - MoronMorónEn recrutement
Instituto Medico de la Fundacion de Estudios ClínicosRosarioEn recrutement
FME San FernandoSan FernandoEn recrutement
Fresenius TucumánSan Miguel de TucumánEn recrutement
Clínica de Nefrología, Urología y Enfermedades CardiovascularesSanta FeEn recrutement

Australia

ÉtablissementVilleÉtat ou régionStatut
Wide Bay Hospital and Health ServiceBundabergRetiré
Cairns HospitalCairnsQueenslandEn recrutement
Monash Medical CentreClaytonVictoriaEn recrutement
Austin HospitalHeidelbergEn recrutement
Liverpool HospitalLiverpoolEn recrutement
Fiona Stanley HospitalMurdochEn recrutement
Sunshine Coast University Private HospitalNambourEn recrutement
Sunshine Coast University Private HospitalNambourQueenslandSuspendu
Royal Melbourne HospitalParkvilleEn recrutement
Royal North Shore Hospital (RNSH)Saint LeonardsNew South WalesEn recrutement
Gold Coast University HospitalSouthportEn recrutement
Sunshine HospitalSt AlbansVictoriaEn recrutement
Concord Repatriation General HospitalSydneyNew South WalesEn recrutement
Fraser Coast Renal Service, Hervey Bay HospitalUrraweenEn recrutement
Sydney Adventist HospitalWahroongaEn recrutement
Westmead HospitalWestmeadEn recrutement
Wollongong Renal UnitWollongongEn recrutement
Princess Alexandra HospitalWoolloongabbaQueenslandSuspendu

Austria

ÉtablissementVilleÉtat ou régionStatut
Wiener Gesundheitsverbund - Klinik HietzingViennaEn recrutement

Belgium

ÉtablissementVilleÉtat ou régionStatut
Onze-Lieve-Vrouwziekenhuis VZWAalstEn recrutement
Imelda ZiekenhuisBonheidenEn recrutement
Centre Hospitalier Universitaire (CHU) de Charleroi - Hopital Civil Marie CurieCharleroiEn recrutement
AZ Sint-LucasGhentSuspendu
Centre Hospitalier Universitaire de TivoliLa LouvièreEn recrutement
Jan Yperman ZiekenhuisLeperEn recrutement
Universitair Ziekenhuis LeuvenLeuvenEn recrutement
CHR de la CitadelleLiègeEn recrutement
AZ Delta (H.-Hartziekenhuis Roeselare-Menen vzw (HHRM)) - Campus RumbekeRoeselareEn recrutement
VITAZ, Department Nierziekten & DialyseSint-NiklaasEn recrutement

Brazil

ÉtablissementVilleÉtat ou régionStatut
NUPEC-Nucleo de Pesquisa ClinicaBelo HorizonteEn recrutement
Santa Casa de Misericordia de Belo HorizonteBelo HorizonteEn recrutement
Hospital Universitário Walter Cantídio (Fortaleza)FortalezaEn recrutement
Empresa Brasileira de Serviços Hospitalares (EBSERH)GoiâniaEn recrutement
Fundacao Pro Rim de Santa CatarinaJoinvilleEn recrutement

507 sites supplémentaires sont indiqués dans la fiche du registre.

Documents de l'étude

Aucun document n'est lié dans cette fiche du registre.

Évolution au fil du temps

  1. 11 août 2026

    Site ajouté

    9 sites added (557 total)

    548557

Registre: ClinicalTrials.gov · NCT########

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