Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD Undergoing Dialysis (POSIBIL6ESKD)
Recruiting · NCT05485961 · Interventional (participants receive a specific treatment) · Lead sponsor: CSL Behring
View the official record on ClinicalTrials.gov →Interventions studied
CSL300Placebo
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2, Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
60 locations listed across 33 US states.
- Nephrology of North Alabama - Decatur, Alabama, United States
- Nephrology of North Alabama - Decatur, Alabama, United States
- Nephrology Consultants, LLC - Huntsville, Alabama, United States
- Nephrology Consultants, LLC - Huntsville, Alabama, United States
- DaVita Clinical Research Montgomery - Montgomery, Alabama, United States
- DaVita Clinical Research Montgomery - Montgomery, Alabama, United States
- AKDHC Medical - Glendale, Arizona, United States
- Kidney Disease Medical Group - Glendale, Arizona, United States
- AKDHC Medical - Glendale, Arizona, United States
- Kidney Disease Medical Group - Glendale, Arizona, United States
- AKDHC Medical - Phoenix, Arizona, United States
- AKDHC Medical - Phoenix, Arizona, United States
- AKDHC Medical - Tucson, Arizona, United States
- Southern Arizona VA Health Care System - Tucson, Arizona, United States
- AKDHC Medical - Tucson, Arizona, United States
- Southern Arizona VA Health Care System - Tucson, Arizona, United States
- National Institute of Clinical Research - Bakersfield, California, United States
- National Institute of Clinical Research - Bakersfield, California, United States
- Amicis Research Center - Beverly Hills, California, United States
- Amicis Research Center - Beverly Hills, California, United States
- California Institute of Renal Research - Chula Vista, California, United States
- California Institute of Renal Research - Chula Vista, California, United States
- The Medical Research Group, Inc. - Fresno, California, United States
- The Medical Research Group, Inc. - Fresno, California, United States
- Davita Fullerton Dialysis Center - Fullerton, California, United States
- National Institute of Clinical Research, Inc. - Fullerton, California, United States
- Davita Fullerton Dialysis Center - Fullerton, California, United States
- National Institute of Clinical Research, Inc. - Fullerton, California, United States
- National Institute of Clinical Research, Inc. - Garden Grove, California, United States
- St. Jude Medical Center - Garden Grove, California, United States
- National Institute of Clinical Research - Garden Grove, California, United States
- National Institute of Clinical Research, Inc. - Garden Grove, California, United States
- St. Jude Medical Center - Garden Grove, California, United States
- National Institute of Clinical Research - Garden Grove, California, United States
- Sherman Medical Group, Inc - Glendale, California, United States
- Kidney Disease Medical Group - Glendale, California, United States
- Sherman Medical Group, Inc - Glendale, California, United States
- Kidney Disease Medical Group - Glendale, California, United States
- Renal Consultants Medical Group - Granada Hills, California, United States
- Renal Consultants Medical Group - Granada Hills, California, United States
- Balboa Research - La Jolla, California, United States
- Balboa Research - La Jolla, California, United States
- California Institute of Renal Research - La Mesa, California, United States
- California Institute of Renal Research - La Mesa, California, United States
- Southern California Medical Research Center - La Palma, California, United States
- Southern California Medical Research Center - La Palma, California, United States
- Academic Medical Research Institute - Los Angeles, California, United States
- National Institute of Clinical Research, Inc. - Los Angeles, California, United States
- DaVita Carabello Dialysis Center - Los Angeles, California, United States
- Cedars-Sinai Medical Center - Los Angeles, California, United States
- Academic Medical Research Institute - Los Angeles, California, United States
- National Institute of Clinical Research, Inc. - Los Angeles, California, United States
- DaVita Carabello Dialysis Center - Los Angeles, California, United States
- Cedars-Sinai Medical Center - Los Angeles, California, United States
- Renal Medical Associates/NARI - Lynwood, California, United States
- Renal Medical Associates/NARI - Lynwood, California, United States
- Amicis Research Center - Northridge, California, United States
- Amicis Research Center - Northridge, California, United States
- FORMAT Medical Research - Oxnard, California, United States
- FORMAT Medical Research - Oxnard, California, United States
Showing 60 of 1114 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →