ONO-5163 Phase III long-term study (ONO-5163-04)

A Multicenter, open-label, uncontrolled, 52-week long-term study in patients with secondary hyperparathyroidism on hemodialysis (ONO-5163-04)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222614

Enrollment

180

Registered

2014-09-30

Start date

2014-10-18

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

investigational material(s) Generic name etc : ONO-5163 INN of investigational material : Etelcalcetide Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration fo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Chronic renal failure patient with a complica-tion of SHPT 2. Patients with a history of hemodialysis 3 times per week for 90 days or more prior to the start of screening period

Exclusion criteria

Exclusion criteria: 1. Patient with primary hyperparathyroidism

Design outcomes

Primary

Measure	Time frame
safety Safety	—

Secondary

Measure	Time frame
efficacy Efficacy	—

Countries

Japan

Outcome results

None listed

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