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.

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. - Evaluation of effective dose of cinacalcet hydrochloride and etelcalcetide hydrochloride

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000027637

Enrollment

120

Registered

2017-06-05

Start date

2017-06-05

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Secondary hyperparathyroidism

Interventions

Etelcalcetide Hydrochloride

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Japanese patients with secondary hyperparathyroidism aged over 20 years old, receiving hemodialysis three times a week. 2. Treated with cinacalcet hydrochloride over 6 months (24 weeks), also administered with the fixed dosage of cinacalcet hydrochloride within three months before screening test. 3. Informed of etelcalcetide hydrochloride, and permitted the switch to etelcalcetide hydrochloride. 4. Patients not changed with the dosage and administration of phosphate binder (including calcium-containing phosphate binder), calcium preparations, and activated vitamin D preparations (oral, intravenous, derivative) within 14 days before screening test. 5. Patients not changed with dialysis procedure and hemodialysis machine (such as dialyzer, hemodialyzer) within 14 days before screening test. 6. Dialysis time is more than 4 hours, as well as hemodialysis dose(Kt/V) is more than 1.2 or urea reduction ratio(URR) is over 65 %. 7. Patients able to provide written informed consent for study participation.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
- 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.	—

Measure

Time frame

- 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.

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Countries

Japan

Contacts

Public ContactYusuke Kaida

Kurume University Division of Nephrology, Department of Medicine

kaida_yuusuke@kurume-u.ac.jp0942-31-7763

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026