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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Trial Registration Coordinator +1 610-878-4697
clinicaltrials@cslbehring.com


Study Location:

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Be Part of Research - Trial Details - Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD Undergoing Dialysis
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Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD Undergoing Dialysis

Recruiting

Open to: ALL

Age: 18.0 - N/A

Bradford Liverpool Londonderry Derby Wolverhampton Birmingham Dorchester London London London London Salford Shrewsbury Coventry Stoke-on-Trent

Medical Conditions

Atherosclerotic Cardiovascular Disease
End Stage Kidney Disease
Atherosclerotic Cardiovascular Disease in Patients With ESKD

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


This is a 2-part (phase 2b/3) 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 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.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Oct 2022 May 2029

Publications

"Chertow GM, Chang AM, Felker GM, Heise M, Velkoska E, Fellstrom B, Charytan DM, Clementi R, Gibson CM, Goodman SG, Jardine M, Levin A, Lokhnygina Y, Mears J, Mehran R, Stenvinkel P, Wang AY, Wheeler DC, Zoccali C, Ridker PM, Mahaffey KW, Tricoci P, Wolf M. IL-6 inhibition with clazakizumab in patients receiving maintenance dialysis: a randomized phase 2b trial. Nat Med. 2024 Aug;30(8):2328-2336. doi: 10.1038/s41591-024-03043-1. Epub 2024 May 25."; "38796655"

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : IV administration

Intervention Arm Group : CSL300 (Phase 3);CSL300 (high dose)(Phase 2b);CSL300 (low dose)(Phase 2b);CSL300 (medium dose)(Phase 2b);

Intervention Type : DRUG
Intervention Description : Matching the excipient content and concentration of the CSL300 product, minus the active ingredient.

Intervention Arm Group : Placebo (Phase 2b);Placebo (Phase 3);



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Bradford Teaching Hospitals NHS Foundation Trust
    Bradford
    BD9 6RJ
  • Royal Liverpool University Hospital
    Liverpool
    L7 8XP
  • Altnagelvin Area Hospital
    Londonderry
    BT47 6SB
  • University Hospitals of Derby and Burton NHS Foundation Trust - Royal Derby Hospital
    Derby
    DE22 3NE
  • The Royal Wolverhampton NHS Trust - New Cross Hospital
    Wolverhampton
    WV10 0QP
  • University Hospitals Birmingham NHS Foundation Trust - Birmingham Heartlands Hospital (BHH)
    Birmingham
    B9 5SS
  • Dorset County Hospital NHS Foundation Trust - Dorset County Hospital (DCH)
    Dorchester
    DT1 2JY
  • William Harvey Research Institute ; Barts Health NHS Trust - The Royal London Hospital
    London
    E1 1BB
  • King´s College NHS Trust
    London
    SE5 9RS
  • St George's University Hospitals NHS Foundation Trust - St G
    London
    SW17 0QT
  • Hammersmith Hospital Imperial College Healthcare NHS Trust -Hammersmith Hospital - West London Renal and Transplant Centre
    London
    W12 0HS
  • Northern Care Alliance NHS Foundation Trust - Salford Royal NHS Foundation Trust-Salford Care Organisation
    Salford
    M6 8HD
  • The Shrewsbury and Telford Hospital NHS Trust (SaTH) - Royal Shrewsbury Hospital
    Shrewsbury
    SY3 8XQ
  • University Hospital Coventry and Warwickshire
    Coventry
    CV2 2DX
  • Royal Stoke University Hospital
    Stoke-on-Trent
    ST4 6QG

Trial Registration Coordinator +1 610-878-4697
clinicaltrials@cslbehring.com



The study is sponsored by CSL Behring



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Read full details for Trial ID: NCT05485961
Last updated 30 April 2026

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