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New treatment option for End Stage Kidney Disease
Official title Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD Undergoing Dialysis (POSIBIL6ESKD)
ClinicalTrials.gov ID: NCT05485961
What this study is testing
What is CSL300?
CSL300 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for end stage kidney disease.
Also referred to as Clazakizumab.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- people 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 people with a positive TB or a history of latent TB, whereas Part 2 (Phase 3) excludes active TB but allows inclusion of...
- 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.
See the full eligibility 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.
- people 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 people with a positive TB or a history of latent TB, whereas Part 2 (Phase 3) excludes active TB but allows inclusion of people with a latent TB and at least 4 weeks of prophylactic TB...
- 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
- Decatur, Alabama, United States
- Huntsville, Alabama, United States
- Montgomery, Alabama, United States
- Glendale, Arizona, United States
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- Bakersfield, California, United States
- Beverly Hills, California, United States
- Chula Vista, California, United States
- Fresno, California, United States
- Fullerton, California, United States
- Garden Grove, California, United States
- Glendale, California, United States
- Granada Hills, California, United States
- La Jolla, California, United States
- La Mesa, California, United States
- La Palma, California, United States
- Los Angeles, California, United States
- Lynwood, California, United States
- Northridge, California, United States
+ 427 more site(s).
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Decatur, Alabama, United States; Huntsville, Alabama, United States; Montgomery, Alabama, United States; Glendale, Arizona, United States; Phoenix, Arizona, United States; Tucson, Arizona, United States and 441 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 ClinicalTrials.gov; the study team decides eligibility.