chronic kidney disease-mineral and bone disorders (CKD-MBD) in hemodialysis patients
Conditions
Interventions
Group A: iPTH control target within current guidelines, within the range of iPTH 60 pg/mL to 120 pg/mL using Upacicalcet
Group B: iPTH management target within current guidelines, with iPTH between 18
Sponsors
Tokushukai Shonan Kamakura General Hospital (Clinical Research Center)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Maintenance hemodialysis patients who have been receiving hemodialysis 3 times a week for at least 3 months after induction of hemodialysis 2) Male and female patients aged between 18 and 86 years old at the time of consent 3) Serum iPTH level of 240 pg/mL or higher during the observation period 4) Serum corrected Ca level of 8.4 mg/dL or higher at the observation period 5) Research subjects who have given a thorough explanation of their participation in this study and have given their free and voluntary written consent 6) Outpatients
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of serum P and Ca concentrations achieving control targets at the end of treatment (52 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Amount and rate of change in bone mineral density (DXA method, lumbar vertebrae and femur) before and after administration 2) Intact PTH, P, Ca, Ca x P product at baseline and 13, 26, and 52 weeks, bone metabolism markers (P1NP, BAP, TRACP-5b) at baseline and 26 and 52 weeks, intact FGF23, 25-OH vitamin D, BNP, heart echo, CAVI, ABI, TBI | — |
Countries
Japan
Contacts
Public ContactSumi Hidaka
Shonan Kamakura General Hospital Kideny Disease and Transplant Center
Outcome results
None listed