RightFit
RecruitingPhase 2 / Phase 3

Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD Undergoing Dialysis (POSIBIL6ESKD)

A Phase 2b / 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Combined Dose-Finding and Cardiovascular Outcome Study to Investigate the Efficacy and Safety of CSL300 (Clazakizumab) in Subjects With End Stage Kidney Disease Undergoing Dialysis

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests CSL300 (clazakizumab) against a placebo, a treatment with no active drug. It aims to find a dose and check safety and effects on heart and blood vessel problems. It is for adults on dialysis for kidney failure who have inflammation and either diabetes or artery disease caused by plaque buildup.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older.
  • Have end-stage kidney disease (kidney failure) and have been on regular dialysis for at least 12 weeks.
  • Have an hs-CRP blood test result of at least 2.0 mg/L, a sign of inflammation.
  • Have diabetes or heart and blood vessel disease caused by plaque buildup in arteries.

Who can't join

  • Took part in Part 1 of this study and want to join Part 2.
  • Currently use medicines that weaken the immune system throughout the body.
  • Part 1: Have a positive tuberculosis (TB) test or a history of latent TB (inactive TB). Part 2: Have active TB; inactive TB is allowed after at least 4 weeks of medicine to prevent active TB.
  • Have abnormal liver blood test results.
  • Have a life-threatening disease expected to cause death within 12 months.
  • Have a history of a hole in the stomach or bowel, inflammatory bowel disease, or stomach or upper bowel ulcers. Ulcerative colitis is allowed if all affected bowel has been removed.
  • Have a current infection serious enough to affect your health, or a history of an infection that occurs when the immune system is weak or a fungal infection that spreads into the body.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion 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. Exclusion Criteria: * Subjects 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 subjects with a positive TB or a history of latent TB, whereas Part 2 (Phase 3) excludes active TB but allows inclusion of subjects with a latent TB and at least 4 weeks of prophylactic TB treatment. * 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.

Study sites (167)

AL

AZ

CA

CO

CT

DE

FL

GA

IA

IN

KS

  • Kansas Nephrology Physicians, PA · Wichita, KS 67214Use Central Contact · Study contactMore trials in Wichita

KY

  • Nephrology Associates of Kentuckiana, PSC · Louisville, KY 40205Use Central Contact · Study contactMore trials in Louisville

LA

MA

MI

MN

MO

MS

NC

NE

NH

  • Seacoast Kidney and Hypertension Specialists · Portsmouth, NH 03801Use Central Contact · Study contactMore trials in Portsmouth

NJ

NM

NV

  • DaVita Clinical Research - Henderson · Henderson, NV 89074Use Central Contact · Study contactMore trials in Henderson
  • Kidney Specialists of Southern Nevada · Las Vegas, NV 89106Use Central Contact · Study contactMore trials in Las Vegas
  • Sierra Nevada Specialty Care · Reno, NV 89511Use Central Contact · Study contactMore trials in Reno

NY

OH

PA

RI

SC

TN

TX

VA

WV

  • Nephrology and Hypertension Associates · Bluefield, WV 24701Use Central Contact · Study contactMore trials in Bluefield