The relationship of the effective dose and safety of cinacalcet hydrochloride and etelcalcetide hydrochloride in the Japanese patients with secondary hyperparathyroidism receiving hemodialysis, when switching cinacalcet hydrochloride to etelcalcetide hydrochloride.

Not Applicable

• Conditions: Secondary hyperparathyroidism

• Registration Number: JPRN-UMIN000027637
• Lead Sponsor: Division of Nephrology, Department of Medicine, Kurume University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-06-05
• Study Completion: 2018-12-10
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

1. Serum cCA is less than 8.4mg/dL at screening test. 2. Primary hyperparathyroidism 3. Plan to receive parathyroidectomy, parathyroid intervention, or kidney transplant during the study treatment. 4. Serum iPTH is less than 60 pg/mL 5. Poor medication compliance of cinacalcet hydrochloride (less than 50%) 6. Pregnant woman, or a woman who have possibility of pregnancy, wish to be pregnant, or lactating. 7. Others not inadequate judged by a physician.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dose distribution of etelcalcetide hydrochloride in patients achieved serum iPTH goal (60-240pg/mL) after 24 weeks of switching to etelcalcetide hydrochloride per cinacalcet hydrochloride treated group.

Secondary Outcome Measures

Name	Time	Method
- Dose distribution of etelcalcetide hydrochloride in patients achieved serum iPTH goal (60-240pg/mL) after 24 weeks of switching to etelcalcetide hydrochloride in the cinacalcet hydrochloride treated group with serum iPTH goal (60-240pg/mL). - Chronological change amount and change rate of serum iPTH concentration from the start of study treatment. - Chronological change amount and change rate of serum cCa concentration from the start of study treatment. - Chronological change amount and change rate of serum P concentration from the study initiation.