Trials / Completed
CompletedNCT04027517
A Study to Evaluate Efficacy and Safety of JTZ-951 Compared to Darbepoetin Alfa in Korean Renal Anemia Patients Receiving Hemodialysis.
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.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 172 (actual)
- Sponsor
- JW Pharmaceutical · Industry
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
The primary objective is to demonstrate non-inferiority of JTZ-951 to darbepoetin alfa.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | JTZ-951 | Oral tablet * Dose adjustments as maintenance dose is allowed according to the result of Hb level. |
| DRUG | Darbepoetin Alfa | Intravenous administration * Dose adjustments as maintenance dose is allowed according to the result of Hb level. |
Timeline
- Start date
- 2019-01-15
- Primary completion
- 2021-02-23
- Completion
- 2021-02-23
- First posted
- 2019-07-22
- Last updated
- 2021-03-22
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT04027517. Inclusion in this directory is not an endorsement.