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

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ClinicalTrials.gov Identifier: NCT04027517
Recruitment Status : Recruiting
First Posted : July 22, 2019
Last Update Posted : July 22, 2019
Sponsor:
Information provided by (Responsible Party):
JW Pharmaceutical

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.


Condition or disease Intervention/treatment Phase
Anemia of Chronic Kidney Disease Drug: JTZ-951 Drug: Darbepoetin Alfa Phase 3

Detailed Description:
The primary objective is to demonstrate non-inferiority of JTZ-951 to darbepoetin alfa.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-center, Randomized, Open-label, Active-controlled, Parallel-group, Phase III Study to Compare the Efficacy and Safety of JTZ-951 With Darbepoetin Alfa in Anemic Patients With Chronic Kidney Disease Receiving Maintenance Hemodialysis.
Actual Study Start Date : January 15, 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: JTZ-951
Oral doses once daily
Drug: JTZ-951

Oral tablet

  • Dose adjustments as maintenance dose is allowed according to the result of Hb level.
Other Name: enarodustat

Active Comparator: Darbepoetin Alfa
Intravenous doses of Darbepoetin Alfa administered once weekly
Drug: Darbepoetin Alfa

Intravenous administration

  • Dose adjustments as maintenance dose is allowed according to the result of Hb level.
Other Name: Nesp pre-filled syringe




Primary Outcome Measures :
  1. Difference in mean Hb level change during the evaluation period from baseline (evaluation period - baseline) between study arm and control arm [ Time Frame: baseline and Week 20 to 24 ]
    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).

  2. Difference in mean Hb level between study arm and control arm during the evaluation period [ Time Frame: baseline and Week 20 to 24 ]
    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).


Secondary Outcome Measures :
  1. Proportion of subjects with Hb level within the range of baseline ± 1.0 g/dL at Week 4 [ Time Frame: Week4 ]
  2. Proportion of subjects with mean Hb level of ≥10.0 g/dL and <12.0 g/dL during the evaluation period [ Time Frame: Week 20, 22, 24 ]
  3. Hb level at each Visit [ Time Frame: Week 2, 4, 8, 12, 16, 20, 22, 24 ]
  4. Change from baseline in Hb level at each Visit [ Time Frame: Week 0, 2, 4, 8, 12, 16, 20, 22, 24 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Korean patients aged ≥ 19 years at the time of consent
  2. Patients receiving hemodialysis (including hemodiafiltration) consistently three times a week for at least 12 weeks before Scr Visit 1
  3. Patients with TSAT (Transferrin saturation) *2 > 20% or ferritin > 75 ng/mL at Scr Visit 1*1
  4. Patients being treated with ESAs for as least 4 weeks before Scr Visit 1.
  5. Patients receiving ESAs at protocol specified dose regimen (i.e., frequency and dose)
  6. 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.
  7. 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

Exclusion Criteria:

  1. Patients with poorly controlled hypertension
  2. Patients with severe hepatobiliary disease
  3. Patients with congestive heart failure (NYHA Class III or more) or unstable angina
  4. 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.
  5. 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
  6. Patients who have undergone erythrocyte transfusion during the period between 12 weeks before Scr Visit 1 and Week 0.
  7. Patients who have received protein anabolic hormones, testosterone enanthate, or mepitiostane during the period between 12 weeks before Scr Visit 1 and Week 0.
  8. Patients with severe hyperparathyroidism
  9. 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)
  10. Patients who are suspected to have anemia caused by noninfectious chronic inflammatory disease (e.g., connective tissue disease)
  11. Patients with malignancy (including hematological malignancy) or previous history of malignancy during the period between 5 years before Scr Visit 1 and Week 0
  12. Patients with previous history of a serious drug allergy such as anaphylactic shock or a hypersensitivity to DA
  13. Patients with current or previous history of drug dependence or alcohol dependence
  14. 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
  15. Patients who have previously participated in a clinical study of JTZ-951 and received the investigational product
  16. Patients who are pregnant, lactating, or may be pregnant (the possibility of pregnancy cannot be ruled out by the PI or the SI based on the results of pregnancy test at Scr Visit 1)
  17. Female patients of childbearing potential who have not agreed to use appropriate contraception methods (medically accepted contraceptive methods: surgical sterilization, intrauterine device, condom, diaphragm, etc.) from the time of signing of informed consent to the end of the study, or male patients who have not agreed to use appropriate contraception methods from the start of study treatment to the end of the study.
  18. Other patients who, in the judgment of the PI or the SI, are ineligible for the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04027517


Locations
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Korea, Republic of
SMG-SNU Boramae Medical Center Recruiting
Seoul, Korea, Republic of
Contact: ChunSoo Lim    +82 2-870-3865    cslimjy@gmail.com   
Sponsors and Collaborators
JW Pharmaceutical
Investigators
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Study Chair: Lee JW Pharmaceutical

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Responsible Party: JW Pharmaceutical
ClinicalTrials.gov Identifier: NCT04027517     History of Changes
Other Study ID Numbers: JWP-JTZ-301
First Posted: July 22, 2019    Key Record Dates
Last Update Posted: July 22, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Anemia
Hematologic Diseases
Urologic Diseases
Renal Insufficiency
Darbepoetin alfa
Hematinics