Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD Undergoing Dialysis
Phase 2/3 – combined trial
Conditions:
Atherosclerotic Cardiovascular Disease
End Stage Kidney Disease
Atherosclerotic Cardiovascular Disease in Patients With ESKD
Sponsor: CSL Behring
trial.available_in:
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Overview
This is a 2-part (phase 2b/3) 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 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 participate
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
* \- 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
Locations
30
Argentina (1)
FME Lomas de Zamora
Banfield
Australia (1)
Royal North Shore Hospital (RNSH)
Saint Leonards , New South Wales
Belgium (1)
Onze-Lieve-Vrouwziekenhuis VZW
Aalst
Brazil (1)
Santa Casa de Misericordia de Belo Horizonte
Belo Horizonte
Bulgaria (1)
Multiprofile Hospital for Active Treatment - Dobrich AD
Dobrich
Canada (1)
University of Alberta Hospital
Edmonton , Alberta
China (1)
Inner Mongolia Baotou City Central Hospital (Baotou Central Hospital)
Baotou Shi
Czech Republic (1)
Interni Oddeleni Nemocnice
Český Krumlov
Denmark (1)
Aalborg Universitetshospital
Aalborg
France (1)
CHU Amiens - Nephrology Dialysi Transplantation Department
Amiens
Greece (1)
University Hospital of Alexandroupolis
Alexandroupoli
Hong Kong (1)
Princess Margaret Hospital
Ho Man Tin
Hungary (1)
Somogy Megyei Kaposi Mor Oktato Korhaz
Kaposvár
Israel (1)
Emek Medical Center
Afula
Italy (1)
Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi
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