A Study to Evaluate Efficacy and Safety of JTZ-951 Compared to Darbepoetin Alfa in Korean Renal Anemia Patients Receiving Hemodialysis.

NCT04027517 | Completed Phase 3

• 1 other identifier: JWP-JTZ-301
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

Brief Summary

JTZ-951 is a currently being developed as a treatment for renal anemia. This study aims to evaluate the efficacy and safety of JTZ-951 following a switch from erythropoiesis-stimulating agent (ESA) in Korean subjects receiving HemoDialysis with renal anemia. This study is a Phase III, open, active-controlled, parallel-group, multi-center study. The total duration of the study will be 30 weeks including screening, treatment and follow-up.

Conditions

Anemia of Chronic Kidney Disease

Outcome Measures

Primary Outcomes (2)

• Difference in mean Hb level change during the evaluation period from baseline (evaluation period - baseline) between study arm and control arm

  Hb level during the evaluation period is the mean of the Hb levels at Week 20, Week 22 and End of Treatment (Week 24 or at discontinuation).

  baseline and Week 20 to 24

• Difference in mean Hb level between study arm and control arm during the evaluation period

  Hb level during the evaluation period is the mean of the Hb levels at Week 20, Week 22 and End of Treatment (Week 24 or at discontinuation).

  baseline and Week 20 to 24

Secondary Outcomes (4)

• Proportion of subjects with Hb level within the range of baseline ± 1.0 g/dL at Week 4

  Week4

• Proportion of subjects with mean Hb level of ≥10.0 g/dL and <12.0 g/dL during the evaluation period

  Week 20, 22, 24

• Hb level at each Visit

  Week 2, 4, 8, 12, 16, 20, 22, 24

• Change from baseline in Hb level at each Visit

  Week 0, 2, 4, 8, 12, 16, 20, 22, 24

Study Arms (2)

JTZ-951

EXPERIMENTAL

Oral doses once daily

Drug: JTZ-951

Darbepoetin Alfa

ACTIVE COMPARATOR

Intravenous doses of Darbepoetin Alfa administered once weekly

Drug: Darbepoetin Alfa

Interventions

JTZ-951 DRUG

Oral tablet * Dose adjustments as maintenance dose is allowed according to the result of Hb level.

Also known as: enarodustat

JTZ-951

Darbepoetin Alfa DRUG

Intravenous administration * Dose adjustments as maintenance dose is allowed according to the result of Hb level.

Also known as: Nesp pre-filled syringe

Darbepoetin Alfa

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Korean patients aged ≥ 19 years at the time of consent
• Patients receiving hemodialysis (including hemodiafiltration) consistently three times a week for at least 12 weeks before Scr Visit 1
• Patients with TSAT (Transferrin saturation) \*2 \> 20% or ferritin \> 75 ng/mL at Scr Visit 1\*1
• Patients being treated with ESAs for as least 4 weeks before Scr Visit 1.
• Patients receiving ESAs at protocol specified dose regimen (i.e., frequency and dose)
• Patients who have received the same ESA received in most recent week before Scr Visit 1 as during the period between Scr Visit 1 and the day before Week 0 at the same total dose and dosing frequency a week\*4.
• Patients with pre-dialysis Hb levels measured after the maximum interdialytic interval at Scr Visit 1 and Scr Visit 2 (2 weeks after Scr Visit 1) of ≥ 9.5 g/dL and \< 12.0 g/dL and a difference (in absolute value) between Scr Visit 1 and Scr Visit 2 of ≤1.0 g/dL

You may not qualify if:

• Patients with poorly controlled hypertension
• Patients with severe hepatobiliary disease
• Patients with congestive heart failure (NYHA Class III or more) or unstable angina
• Patients who have developed myocardial infarction, cerebral infarction (excluding asymptomatic cerebral infarction), or venous thromboembolism (pulmonary embolism or deep vein thrombosis) during the period between 24 weeks before Scr Visit 1 and Week 0.
• Patients who will undergo an ophthalmological procedure (photocoagulation therapy or vitreous surgery) for the treatment of diabetic retinopathy, diabetic macular edema, or age- related macular degeneration during the period between Scr Visit 1 and the end of the study
• Patients who have undergone erythrocyte transfusion during the period between 12 weeks before Scr Visit 1 and Week 0.
• Patients who have received protein anabolic hormones, testosterone enanthate, or mepitiostane during the period between 12 weeks before Scr Visit 1 and Week 0.
• Patients with severe hyperparathyroidism
• Patients with severe infection, systemic blood disorder (e.g., myelodysplastic syndrome, aplastic anemia, abnormal hemoglobin disease), or hemolytic anemia, or patients with anemia caused by obvious bleeding lesions (e.g., gastrointestinal hemorrhage)
• Patients who are suspected to have anemia caused by noninfectious chronic inflammatory disease (e.g., connective tissue disease)
• Patients with malignancy (including hematological malignancy) or previous history of malignancy during the period between 5 years before Scr Visit 1 and Week 0
• Patients with previous history of a serious drug allergy such as anaphylactic shock or a hypersensitivity to DA
• Patients with current or previous history of drug dependence or alcohol dependence
• Patients who have received another investigational product or have received treatment with an investigational device, or have participated in clinical research involving intervention (medical action beyond the scope of ordinary medical practice intended for research purposes) and received treatment within 12 weeks before Scr Visit 1
• Patients who have previously participated in a clinical study of JTZ-951 and received the investigational product

Sponsors & Collaborators

• JW Pharmaceutical: lead

Study Sites (1)

SMG-SNU Boramae Medical Center

Seoul, South Korea

Location

Related Publications (1)

• Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.

  PMID: 36005278 DERIVED

MeSH Terms

Interventions

enarodustat; Darbepoetin alfa

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Lee

  JW Pharmaceutical

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2019
• First Posted: July 22, 2019
• Study Start: January 15, 2019
• Primary Completion: February 23, 2021
• Study Completion: February 23, 2021
• Last Updated: March 22, 2021

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)