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

An Early Phase 2 Study to Explore the Efficacy and Safety of JTZ-951 in Renal Anemic Patients Receiving Maintenance Hemodialysis

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222207

Enrollment

Registered

2013-09-03

Start date

2013-09-02

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

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 -Pre-dialysis hemoglobin level of= > 9.0 g/dL and < 10.0 g/dL

Exclusion criteria

Exclusion criteria: -Uncontrollable hypertension -Congestive heart failure (NYHA classification III or higher) -Excessive bleeding associated with surgical operation or blood transfusion 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
pharmacokinetics safety efficacy -Reticulocyte count, hematocrit level, red blood cell count -Subjective symptoms, objective findings, vital signs, 12-lead ECG, laboratory tests -Plasma concentrations of JTZ-951	—

Countries

Japan

Outcome results

None listed

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