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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||156 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Oral doses once daily
Other Name: enarodustat
Active Comparator: Darbepoetin Alfa
Intravenous doses of Darbepoetin Alfa administered once weekly
Drug: Darbepoetin Alfa
Other Name: Nesp pre-filled syringe
- 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).
- 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).
- Proportion of subjects with Hb level within the range of baseline ± 1.0 g/dL at Week 4 [ Time Frame: Week4 ]
- 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 ]
- Hb level at each Visit [ Time Frame: Week 2, 4, 8, 12, 16, 20, 22, 24 ]
- Change from baseline in Hb level at each Visit [ Time Frame: Week 0, 2, 4, 8, 12, 16, 20, 22, 24 ]
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
|Korea, Republic of|
|SMG-SNU Boramae Medical Center||Recruiting|
|Seoul, Korea, Republic of|
|Contact: ChunSoo Lim +82 2-870-3865 email@example.com|
|Study Chair:||Lee||JW Pharmaceutical|