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Combined Dose-Finding and CV Outcomes Study with CSL300 (Clazakizumab) in Adult Subjects with ESKD Undergoing Dialysis (POSIBIL6ESKD).
EU CTIS ID: 2022-500273-14-00
What this study is testing
To evaluate the efficacy of different intravenous doses of CSL300 in subjects with ESKD undergoing maintenance dialysis on reduction of high-sensitivity C-reactive protein (hs-CRP).
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male or female at least 18 years of age.
- A diagnosis of End Stage Kidney Diseas (ESKD) undergoing maintenance dialysis for at least 12 weeks
- Serum hs-CRP ≥ 2.0 mg/L.
- A diagnosis of diabetes mellitus OR Atherosclerotic Cardiovascular Disease (ASCVD)
You likely can't join if
- 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 disease.
- Clinically significant active infection or history of opportunistic or invasive fungal infection
The study team makes the final eligibility decision.
Where it's taking place
- Thailand
- United States
- Hong Kong
- Brazil
- Canada
- Korea, Republic of
- China
- Malaysia
- Australia
- Israel
- Mexico
- Argentina
- United Kingdom
- Turkey
- Taiwan
- Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Thailand; United States; Hong Kong; Brazil; Canada; Korea, Republic of and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.