Phase 3 Study of SK-1403

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224528

Enrollment

150

Registered

2019-01-24

Start date

2019-01-21

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 Receiving Hemodialysis

Interventions

investigational material(s) Generic name etc : SK-1403 INN of investigational material : upacicalcet Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for I

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Serum PTH>240 pg/mL at the screening -Serum corrected Ca>=8.4 mg/dL at the screening -Stable chronic kidney disease patients who undergo hemodialysis or hemodialysis filtration

Exclusion criteria

Exclusion criteria: -Primary hyperparathyroidism -Severe liver disease -Severe Cardiac disease -History or family history of long QT syndrome -Malignant tumor -Uncontrolled diabetes mellitus -Uncontrolled hypertension -History of severe drug allergy

Design outcomes

Primary

Measure	Time frame
efficacy Rate of participants who achieved a mean serum iPTH level of >= 60 pg/mL and =< 240 pg/mL from 22 to 24 week.	—

Secondary

Measure	Time frame
efficacy -Rate of participants who achieved a serum iPTH level of >= 60 pg/mL and =< 240 pg/mL at each time point. -Measured values and Changes from baseline in serum PTH, Ca, ionized Ca, P, serum Ca x P product	—

Countries

Japan

Outcome results

None listed

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