Late Phase 2 Study of JTZ-951 in Anemic Patients with Chronic Kidney Disease Receiving Maintenance Hemodialysis

Late Phase 2 Double-Blind Study to Assess the Dose-Response of JTZ-951 in Anemic Patients with Chronic Kidney Disease Receiving Maintenance Hemodialysis

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222839

Enrollment

Registered

2015-05-11

Start date

2015-05-26

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

Anemia with CKD

Interventions

investigational material(s) Generic name etc : JTZ-951 INN of investigational material : Enarodustat Therapeutic category code : 339 Other agents relating to blood and body fluides Dosage and Administ

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: *Patients receiving hemodialysis consistently 3 times weekly *Hemoglobin level of = > 8.5 g/dL and < 10.0 g/dL

Exclusion criteria

Exclusion criteria: *Uncontrollable hypertension *Congestive heart failure (NYHA classification III or higher) *Blood transfusion or excessive bleeding associated with surgical operation within 12 weeks preceding the study *IV iron replacement therapy within 4 weeks preceding the study *Using anabolic androgenic steroid, testosterone enanthate or mepitiostan within 12 weeks preceding the study *Severe infection, Systemic hematological disease, hemolytic anemia or hemorrhagic lesion

Design outcomes

Primary

Measure	Time frame
efficacy Hemoglobin level	—

Secondary

Measure	Time frame
safety efficacy pharmacokinetics Observed and change in Hb level Proportion of subjects maintaining an Hb level within the target range Subjective symptoms, objective findings, vital signs, 12-lead ECG, laboratory tests etc. Plasma concentrations of JTZ-951	—

Countries

Japan

Outcome results

None listed

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