Trials / Completed
CompletedNCT02044653
Study to Evaluate the Efficacy and Safety of GX-E2 in the Anemic Patients Diagnosed With Chronic Kidney Disease (CKD)
Phase II Clinical Trial to Explore the Optimal Fixed Starting Dose & Dosing Interval and to Evaluate the Safety of GX-E2 in the Anemic Patients Diagnosed With Chronic Kidney Disease and Receiving Hemodialysis (HD) / Peritoneal Dialysis (PD)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 257 (actual)
- Sponsor
- Genexine, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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
Detailed description
The secondary objective of study is to evaluate: * change of red blood cell indices in anemic patients with chronic kidney disease receiving hemodialysis/peritoneal dialysis when administering GX-E2 intravenously/subcutaneously * change of reticulocyte indices in anemic patients with chronic kidney disease receiving hemodialysis/peritoneal dialysis when administering GX-E2 intravenously/subcutaneously * safety of GX-E2 when administering intravenously/subcutaneously * incidence of blood transfusion in anemic patients with chronic kidney disease receiving hemodialysis/peritoneal dialysis when administering GX-E2 intravenously/subcutaneously * Immunogenicity in anemic patients with chronic kidney disease receiving hemodialysis/peritoneal dialysis when administering GX-E2 intravenously/subcutaneously
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GX-E2 | Each Group of Peritoneal dialysis patients (n=10) will be administered GX-E2 3ug/kg to 8ug/kg |
| DRUG | GX-E2 | Each Group of Peritoneal dialysis patients (n=24) will be administered GX-E2 5ug/kg to 8ug/kg |
| DRUG | GX-E2 | Each Group of Hemodialysis patients (n=30) will be administered GX-E2 5ug/kg to 8ug/kg |
| DRUG | NESP | Each Group of Hemodialysis (n=30) will be administered NESP 30ug |
| DRUG | MIRCERA | Each Group of Peritoneal dialysis (n=24) will be administered MIRCERA 0.6ug/kg |
Timeline
- Start date
- 2014-04-15
- Primary completion
- 2017-04-20
- Completion
- 2017-04-20
- First posted
- 2014-01-24
- Last updated
- 2017-10-16
Locations
5 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT02044653. Inclusion in this directory is not an endorsement.