Trials / Completed
CompletedNCT04885647
A Study of YPEG-rhEPO in Patients Suffered From Anemia Due to Chronic Kidney Disease
A Multicenter, Randomized, Open-label, Phase 2 Study of YPEG-rhEPO in Patients Suffered From Anemia Due to Chronic Kidney Disease, Who Has Previously Treated With rhEPO and Maintains the Hemoglobin in a Stabilize State
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the effectiveness and safety of YPEG rhEPO, a recombinant human erythropoietin pegylated by Y shape polyethylene glycol, in patients with anemia due to Chronic Kidney Disease (CKD), assessed by hemoglobin maintenance, adverse events and health-related quality of life.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | YPEG-rhEPO | YPEG-rhEPO，low dose，were subcutaneous injected once every two weeks for 13 weeks. |
| DRUG | YPEG-rhEPO | YPEG-rhEPO，low dose，were subcutaneous injected once every four weeks for 13 weeks. |
| DRUG | YPEG-rhEPO | YPEG-rhEPO, high dose，were subcutaneous injected once every two weeks for 13 weeks. |
| DRUG | YPEG-rhEPO | YPEG-rhEPO，high dose，were subcutaneous injected once every four weeks for 13 weeks. |
Timeline
- Start date
- 2021-03-12
- Primary completion
- 2022-01-05
- Completion
- 2022-01-05
- First posted
- 2021-05-13
- Last updated
- 2022-12-16
Locations
17 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04885647. Inclusion in this directory is not an endorsement.