drugset / Trial / NCT02044653
Study to Evaluate the Efficacy and Safety of GX-E2 in the Anemic Patients Diagnosed With Chronic Kidney Disease (CKD)
RandomizedParallel-groupSingle-blindTreatment
Summary
The primary objective of study is * Part A : To explore the optimal fixed starting dose and dosing interval of GX-E2 * Part B : To evaluate the proof of concept (POC) of GX-E2
Timeline
- Start
- 2014-04-15
- Primary completion
- 2017-04-20
- Completion
- 2017-04-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Darbepoetin alfa | Protein / enzyme biologic | 30 ug | Intravenous |
| Subject | GX-E2 | Unknown | 3 ug/kg | Subcutaneous |
| Subject | GX-E2 | Unknown | 5 ug/kg | Subcutaneous |
| Subject | GX-E2 | Unknown | 8 ug/kg | Subcutaneous |
| Comparator | methoxy polyethylene glycol-epoetin beta | Protein / enzyme biologic | 0.6 ug/kg | Subcutaneous |