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Clinical Trial Details

Trial ID: L0681
Source ID: NCT04027517
Associated Drug: Jtz-951
Title: A Study to Evaluate Efficacy and Safety of JTZ-951 Compared to Darbepoetin Alfa in Korean Renal Anemia Patients Receiving Hemodialysis.
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Anemia of Chronic Kidney Disease
Interventions: DRUG: JTZ-951|DRUG: Darbepoetin Alfa
Outcome Measures: Primary: 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: 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
Sponsor/Collaborators: Sponsor: JW Pharmaceutical
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 172
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2019-01-15
Completion Date: 2021-02-23
Results First Posted:
Last Update Posted: 2021-03-22
Locations: SMG-SNU Boramae Medical Center, Seoul, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT04027517