Aortic valve stenosis
Conditions
Interventions
PKR-001 is used in combination with the dialyzer at each hemodialysis session.
Sponsors
Kuro-o Makoto
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Hemodialysis patients determined by echocardiographic assessment to have mild or moderate aortic valve stenosis (The severity will be evaluated by the Image Evaluation Committee based on the echocardiographic images obtained during screening to confirm eligibility according to the inclusion criteria.) (2) Patients aged between 18 and 85 years inclusive at the time of obtaining informed consent
Exclusion criteria
Exclusion criteria: (1) Patients with cardiac disease classified as NYHA Class III or IV (2) Patients with replacement of the native aortic valve by a prosthetic valve (3) Patients with severe stenosis or severe regurgitation of the mitral, tricuspid, and/or pulmonary valves (4) Patients with significant untreated congenital heart disease (e.g., atrial septal defect affecting hemodynamics, right ventricular dysplasia, arrhythmogenic right ventricular cardiomyopathy) (5) Patients who have undergone or are scheduled to undergo vascular treatment or cardiac surgery meeting the following criteria: a. Patients who underwent PCI, EVT, etc. within 30 days prior to consent acquisition, or who are scheduled to undergo PCI, EVT, etc. within 30 days after consent b. Patients who underwent cardiac surgery within 90 days prior to consent acquisition, or who are scheduled to undergo cardiac surgery within 90 days after consent (6) Patients for whom assessment of aortic valve stenosis by echocardiography is difficult due to anatomical features, etc. (7) Patients with rheumatic aortic valve stenosis (8) Patients on hemodialysis for less than 12 weeks at the time of obtaining informed consent (9) Patients who are unable to agree to an appropriate contraceptive method (10) Pregnant or breastfeeding patients (11)Patients judged unlikely to complete the observation period of the study (12)Patients judged to have medically uncontrolled allergies (13)Patients participating in another clinical trial at the time of obtaining informed consent, or with participation in another clinical trial within 12 weeks prior to consent (14) Patients who have previously received treatment with PKR-001 (15)In the opinion of the investigator, any other patients considered inappropriate for participation in this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy at 1, 2, and 3 years after initial treatment and Safety (adverse events, Adverse Device Effect) | — |
Contacts
Public ContactShimpei Terada
KANEKA CORPORATION
Outcome results
None listed