Clinical Trial Details
| Trial ID: | L0572 |
| Source ID: | NCT06466785 |
| Associated Drug: | Efepoetin Alfa |
| Title: | A Phase 3 Study of Efepoetin Alfa for Treatment of Anemia in Patients With Chronic Kidney Disease on Dialysis |
| Acronym: | |
| Status: | RECRUITING |
| Study Results: | NO |
| Results: | |
| Conditions: | Anemia of Chronic Kidney Disease |
| Interventions: | DRUG: Efepoetin Alfa|DRUG: Darbepoetin Alfa |
| Outcome Measures: | Primary: Mean change in hemoglobin (Hb), Mean change from Baseline in Hb averaged over Week 20 to Week 28 without the use of rescue therapy (i.e., transfusion, or any approved ESA for all patients) within 6 weeks prior to and during the 8-week evaluation period., Over Week 20 to Week 28 | |
| Sponsor/Collaborators: | Sponsor: Genexine, Inc. | Collaborators: PT Kalbe Genexine Biologics |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 429 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: TREATMENT |
| Start Date: | 2024-01-25 |
| Completion Date: | 2027-09 |
| Results First Posted: | |
| Last Update Posted: | 2024-06-24 |
| Locations: | Batumi Dialysis and Nephrology Center, Batumi, Georgia|Clinical Center for Nephrology Development, Tbilisi, Georgia|L.Managadze National Center of Urology, Tbilisi, Georgia|Tbilisi Heart And Vascular Clinic, Tbilisi, Georgia|Korea University Ansan Hospital, Ansan, Korea, Republic of|St Mary's Incheon Hospital, Incheon, Korea, Republic of|Kangdong KyungHee University Hospital, Seoul, Korea, Republic of|St Mary's Seoul Hospital, Seoul, Korea, Republic of|St Mary's Yeouido Hospital, Seoul, Korea, Republic of |
| URL: | https://clinicaltrials.gov/show/NCT06466785 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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