End Stage Kidney Disease study: CSL300
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?
an investigational IV medicine being studied as a possible treatment for end stage kidney disease patients on dialysis with cardiovascular risk. is designed to block interleukin‑6 signaling, which may reduce inflammation.
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
- The study first looks for the best dose of clazakizumab, then checks whether that dose reduces cardiovascular problems and is safe in people with end‑stage kidney disease on dialysis.
- Who it's for
- Adults with end‑stage kidney disease on maintenance dialysis who also have systemic inflammation and either known heart disease or diabetes.
- What's involved
- Participants are randomly assigned to receive clazakizumab or a placebo injection, without knowing which they get, and will undergo regular clinic visits and tests to monitor safety and heart outcomes.
- Time commitment
- Participants will attend multiple study visits over the trial’s two phases, including the dose‑finding period and a longer follow‑up period to assess heart outcomes.
- 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 is enrolling
- 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
- 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
- Oxnard, California, United States
+ 400 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, but 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?
This study is enrolling now at 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 414 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.