JPRN-UMIN000052688Not yet recruitingUnknown
Exploration of optimal parathyroid hormone concentrations on markers of chronic kidney disease - mineral and bone disorders (CKD-MBD) in hemodialysis patients. - UTOPIA (SK-2023)
Tokushukai Shonan Kamakura General Hospital (Clinical Research Center)0 sites124 target enrollmentStarted: November 5, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Unknown
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 124
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18years-old to 86years-old (—)
- Sex
- All
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Patients who have any of the following will not be included in this study 1) Patients with a history of parathyroid intervention or fracture within 12 weeks prior to obtaining consent 2) Patients with myocardial infarction or stroke, or lower extremity amputation, or coronary artery reconstruction or lower extremity revascularization within 12 weeks prior to obtaining consent 3) Patients with heart failure of New York heart association (NYHA) cardiac function class III or higher as of the date of consent 4) Patients with respiratory insufficiency with a resting transcutaneous oxygen saturation of peripheral artery (SpO2) of less than 90% as of the date of consent 5) Critically ill patients whose life expectancy is judged to be within 1 year as of the date of consent 6) Patients with severe liver disease (aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 times the upper limit of normal) 7) Patients with active infections or uncured malignant tumors 8) Patients undergoing concomitant peritoneal dialysis 9) Pregnant women or women of childbearing potential 10) Women who are breast-feeding 11) Patients with allergy to Upacicalcet as of the date of consent 12) Patients who, as of the date of consent, were taking estrogen hormones, synthetic estrogens, selective estrogen receptor modulators, calcitonin, bisphosphonates, anti-RANKL (receptor activator of NF-kB ligand) monoclonal antibodies, anti-Sclerostin antibody, parathyroid hormone preparation (teriparatide), or zoledronic acid hydrate injection. 13) Other patients deemed inappropriate as research subjects by the principal investigator or subinvestigator.
Investigators
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