Phase 3 study of subcutaneously-administered SK-1401 in patients with non-dialysis chronic kidney disease

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223471

Enrollment

Registered

2017-03-07

Start date

2016-11-02

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 with non-dialysis chronic kidney disease - Patients treated with each of the following medicine: darbepoetin alfa, epoetin alfa, epoetin beta or epoetin beta pegol - Patients with hemoglobin concentration between 10g/dL - 12.0g/dL (both inclusive)

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 Hemoglobin concentration	—

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