Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD Undergoing Dialysis
Фаза 2/3 – комбинирано изпитване
Заболявания:
Atherosclerotic Cardiovascular Disease
End Stage Kidney Disease
Atherosclerotic Cardiovascular Disease in Patients With ESKD
Спонсор: CSL Behring
Налично на:
БГ
Обобщение
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.
Кой може да участва
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
Места на провеждане
30
Argentina (1)
FME Lomas de Zamora
Banfield
Австралия (1)
Royal North Shore Hospital (RNSH)
Saint Leonards , New South Wales
Белгия (1)
Onze-Lieve-Vrouwziekenhuis VZW
Aalst
Бразилия (1)
Santa Casa de Misericordia de Belo Horizonte
Belo Horizonte
България (1)
Multiprofile Hospital for Active Treatment - Dobrich AD
Dobrich
Канада (1)
University of Alberta Hospital
Edmonton , Alberta
Китай (1)
Inner Mongolia Baotou City Central Hospital (Baotou Central Hospital)
Baotou Shi
Чехия (1)
Interni Oddeleni Nemocnice
Český Krumlov
Дания (1)
Aalborg Universitetshospital
Aalborg
Франция (1)
CHU Amiens - Nephrology Dialysi Transplantation Department
Amiens
Гърция (1)
University Hospital of Alexandroupolis
Alexandroupoli
Hong Kong (1)
Princess Margaret Hospital
Ho Man Tin
Унгария (1)
Somogy Megyei Kaposi Mor Oktato Korhaz
Kaposvár
Израел (1)
Emek Medical Center
Afula
Италия (1)
Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi
БГ
EN