Phase 3 study of intravenously-administered SK-1403 in patients undergoing hemodialysis associated with renal anemia

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223470

Enrollment

150

Registered

2017-03-07

Start date

2016-11-28

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

Renal anemia

Interventions

investigational material(s) Generic name etc : SK-1401 INN of investigational material : - Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investigati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients undergoing hemodialysis - Patients treated with darbepoetin alfa once a week - Patients meet both of the following conditions: Hemoglobin concentrations during the screening period are between 9.5g/dL - 12.5g/dL and mean hemoglobin concentration is between 10g/dL - 12.0g/dL.

Exclusion criteria

Exclusion criteria: - Patients with history of massive bleeding or erythrocyte transfusion - Patients with apparent hemorrhagic lesion - Patients with malignant tumor

Design outcomes

Primary

Measure	Time frame
efficacy Change in mean hemoglobin concentration at 21w-24w from the baseline	—

Secondary

Measure	Time frame
safety Incidence of adverse events or adverse reactions	—

Countries

Japan

Outcome results

None listed

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