Development of treatment strategy for CKD-MBD by multilateral mechanism of etelcalcetide hydrochloride

Phase 3

• Conditions: Secondary hyperparathyroidism

• Registration Number: JPRN-jRCTs041180108
• Lead Sponsor: Maruyama Shoichi

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-18
• Study Completion: 2019-05-06
• Results First Posted: 2020-09-18
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 124

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified