Secondary hyperparathyroidism
Conditions
Interventions
am A: Etelcalcetide+active Vitamin D
am B: Etelcalcetide+oral calcium (calcium carbonate)
am C: Control [active Vitamin D + oral calcium (calcium carbonate)]
Sponsors
Maruyama Shoichi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.patients on maintenance hemodialysis 3 times a week 2.patients with more than one-year hemodialysis vintage 3.patients who are judged stable 4.older than 20 years and younger than 100 years 5.iPTH >=240 pg/ml within 4 months 6.corrected Ca >=8.4mg/dl at enrollment 7.patients who are able to write informed consent
Exclusion criteria
Exclusion criteria: 1.patients who have been prescribed etelcalcetide before 2.bisphosphonate users within 24 weeks 3.primary hyperparathyroidism 4.undergoing parathyroidectomy or intervention therapy to parathyroid within 90 days before enrollment 5.scheduled parathyroidectomy, intervention therapy to parathyroid or kidney plantation 6. pregnant or breast feeding 7. patients who are deemed unsuitable by a physician, for instance cancer, severe infection and severe complication 8. patients who are prescribed Maxacalcitol, over 10[micro]gx3/week at obtainment of IC 9. patients who are prescribed Calcitriol, over 0.75[micro]gx3/week at obtainment of IC 10. patients who are prescribed other active VitD, over half of maximum dose at obtainment of IC 11. patients who are prescribed precipitated calcium carbonate, over 3g/day at obtainment of IC
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ratio of achievement of more than 50% reduction and under 240pg/dl in intact parathyroid hormone (iPTH) after 12 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| -Ratio of achievement of 60<=iPTH<=240 after 12 weeks of treatment -Ratio of achievement of more than 30% reduction in iPTH after 12 weeks of treatment -Ratio of achievement of more than 30% reduction and 60<=iPTH<=240 after 12 weeks of treatment -Ratio of achievement of more than 50% reduction in iPTH after 12 weeks of treatment -Change in iPTH after 2, 4, 6, 8, 10 and 12 weeks of treatment relative to the baseline -Change in CalciProtein Particle (CPP) and Fibroblast Growth Factor 23 (FGF23) after 6 and 12 weeks of treatment relative to the baseline among treatment groups -Change in Ca, P, CaXP and Mg after2, 4, 6, 8, 10 and 12 weeks relative to the baseline among treatment groups -Change in Bone Specific Alkaline Phosphatase (BAP) and Tartrate-resistant Acid Phosphatase 5b (TRACP5b) after one year of treatment relative to the baseline among treatment groups -Comparison of aortic calcification before and after observation -Ca, P and iPTH levels after one year of treatment -Comparison of normalized ratio of hypocalcemia between VitD and calcium preparations -Adverse events | — |
Contacts
Public ContactSawako Kato
Nagoya University Graduate School of Medicine
Outcome results
None listed