JPRN-jRCTs041180108已完成3 期
Development of treatment strategy for CKD-MBD by multilateral mechanism of etelcalcetide hydrochloride - The DUET study
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 124
研究概览
简要总结
Among MHD with SHPT, the use of etelcalcetide showed good control of iPTH. Active active vitamin D was useful in correcting hypocalcemia while oral calcium preparation was superior in suppressing hyperphosphatemia. To reduce cardiovascular disease risks, etelcalcetide may be useful through suppression of FGF23 levels. When correcting hypocalcemia, loading oral calcium preparations could be recommended for the suppression of both FGF23 and CPPs.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 < 100age old（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
相似试验
已完成
不适用
Effect of Active Vitamin D and Etelcalcetide on Human Osteoclasts in Patients With Chronic Kidney DiseaseBone DisorderChronic Kidney DiseasesNCT03527511Hospices Civils de Lyon21
已完成
不适用
Development of treatment strategy for CKD-MBD by multilateral mechanism of ethelcarcitrate hydrochlorideSecondary hyperparathyroidismJPRN-UMIN000030392agoya University Graduate School of Medicine, Nephrology120
已完成
4 期
Paricalcitol Effect on Anemia in CKDAnemiaChronic Kidney DiseaseNCT01768351Federico II University60
已完成
2 期
Activated Vitamin D for the Prevention and Treatment of Acute Kidney InjuryCritically IllAcute Kidney InjuryNCT02962102David Leaf150
尚未招募
不适用
A Study on the Effective Treatment of Mineral - Bone Diseases by Observing Blood Mineral Indicators in Dialysis PatientsKCT0004718Koera University Guro Hospital800