At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- CSL300 (drug), Placebo (drug)
- How long the study runs
- Study runs about 61 months (dates as stated)
- About the drug or intervention
- CSL300 — drug: IV administration · Placebo — drug: Matching the excipient content and concentration of the CSL300 product, minus the active ingredient.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 3,110
- Started
- 2024-04-27
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for end stage kidney disease
- • Phase2/Phase3 - 3,110 participants
- • This is a two-part, phase 2b and phase 3 combined prospective, interventional, multicenter, randomized, double-blind, placebo-controlled study
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with end stage kidney disease
Where?
- • Birmingham - University Hospitals Birmingham NHS Foundation Trust - Birmingham Heartlands Hospital (BHH)
- • Bradford - Bradford Teaching Hospitals NHS Foundation Trust
- • Coventry - University Hospital Coventry and Warwickshire
- • Derby - University Hospitals of Derby and Burton NHS Foundation Trust - Royal Derby Hospital
- • +11 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓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.
Who cannot take part
- ✗Subjects who participated in Part 1 (phase 2b) are not eligible to participate in Part 2 (phase 3).
- ✗Concomitant use of systemic immunosuppressant drugs.
- ✗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...
See the full criteria
Where Is This Study? (15 UK sites)
University Hospitals Birmingham NHS Foundation Trust - Birmingham Heartlands Hospital (BHH)
Birmingham B9 5SS, United Kingdom
Bradford Teaching Hospitals NHS Foundation Trust
Bradford BD9 6RJ, United Kingdom
University Hospital Coventry and Warwickshire
Coventry CV2 2DX, United Kingdom
University Hospitals of Derby and Burton NHS Foundation Trust - Royal Derby Hospital
Derby DE22 3NE, United Kingdom
Dorset County Hospital NHS Foundation Trust - Dorset County Hospital (DCH)
Dorchester DT1 2JY, United Kingdom
Anthony Homer. Research Governance Manager
Research@dchft.nhs.uk01305 253 127Royal Liverpool University Hospital
Liverpool L7 8XP, United Kingdom
William Harvey Research Institute ; Barts Health NHS Trust - The Royal London Hospital
London E1 1BB, United Kingdom
King´s College NHS Trust
London SE5 9RS, United Kingdom
St George's University Hospitals NHS Foundation Trust - St G
London SW17 0QT, United Kingdom
Hammersmith Hospital Imperial College Healthcare NHS Trust -Hammersmith Hospital - West London Renal and Transplant Centre
London W12 0HS, United Kingdom
Altnagelvin Area Hospital
Londonderry BT47 6SB, United Kingdom
Northern Care Alliance NHS Foundation Trust - Salford Royal NHS Foundation Trust-Salford Care Organisation
Salford M6 8HD, United Kingdom
The Shrewsbury and Telford Hospital NHS Trust (SaTH) - Royal Shrewsbury Hospital
Shrewsbury SY3 8XQ, United Kingdom
Royal Stoke University Hospital
Stoke-on-Trent ST4 6QG, United Kingdom
The Royal Wolverhampton NHS Trust - New Cross Hospital
Wolverhampton WV10 0QP, United Kingdom
How to Get in Touch
Trial Registration Coordinator
Sponsor contactCONTACT