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Anemia of Chronic Kidney DiseasePhase 3NCT04027517

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

A Phase 3 study testing JTZ-951 and Darbepoetin Alfa in people with Anemia of Chronic Kidney Disease, run by JW Pharmaceutical at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Anemia of Chronic Kidney Disease
What is being tested?
JTZ-951 and Darbepoetin Alfa
Could I receive a placebo?
No, everyone receives an active treatment
How many people
172 participants
Where
1 siteSouth Korea
Study dates
15 Jan 2019to 23 Feb 2021
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
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  • 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
  • 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)
  • 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.
  • Other patients who, in the judgment of the PI or the SI, are ineligible for the study

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • SMG-SNU Boramae Medical Center

    Seoul

Other trials in South Korea

About this study

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.

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.

Read the detailed description

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

Being tested
JTZ-951, Darbepoetin Alfa

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JTZ-951Drug

    Also called enarodustat

    Oral tablet

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

  • Darbepoetin AlfaDrug

    Also called Nesp pre-filled syringe

    Intravenous administration

    • Dose adjustments as maintenance dose is allowed according to the result of Hb level.
Study groups in NCT04027517
Study groupRoleWhat they receive
JTZ-951ExperimentalOral doses once daily
Receives: Drug: JTZ-951
Darbepoetin AlfaActive comparatorIntravenous doses of Darbepoetin Alfa administered once weekly
Receives: Drug: Darbepoetin Alfa

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: baseline and Week 20 to 24

  2. 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).

    Measured: baseline and Week 20 to 24

Secondary outcomes (4)

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

    Measured: Week4

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

    Measured: Week 20, 22, 24

  3. Hb level at each Visit

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

  4. Change from baseline in Hb level at each Visit

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2019
  2. Study start15 Jan 2019
  3. Primary completion23 Feb 2021
  4. Study completion23 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
172 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04027517
Sponsor's protocol ID
JWP-JTZ-301
Status last verified
Aug 2020
First submitted
10 Jul 2019
Last updated
22 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36005278

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing JTZ-951 and Darbepoetin Alfa in people with Anemia of Chronic Kidney Disease, run by JW Pharmaceutical at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04027517, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2021.

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