Late Phase 2 Study of JTZ-951 in Anemic Patients with Chronic Kidney Disease Not Requiring Dialysis

Late Phase 2 Double-Blind Study to Assess the Dose-Response of JTZ-951 in Anemic Patients with Chronic Kidney Disease Not Requiring Dialysis

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222829

Enrollment

160

Registered

2015-04-23

Start date

2015-05-14

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 with chronic kidney disease not requiring dialysis * Group 1 (ESA-naive): Hemoglobin level of = > 8.0 and = 9.5 and = < 12.0 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 mepitiostane 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