Anemia Clinical Trial
| Verified date | March 2019 |
| Source | Kissei Pharmaceutical Co., Ltd. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to investigate the equivalence of JR-131 to Darbepoetin alfa and evaluate the safety of JR-131 in renal anemia patients with chronic kidney disease (CKD).
| Status | Completed |
| Enrollment | 0 |
| Est. completion date | September 2017 |
| Est. primary completion date | September 2017 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | 20 Years and older |
| Eligibility |
Inclusion Criteria: - Patients being treated with Darbepoetin alfa. Exclusion Criteria: - Patients having complication or history of a cardiovascular / lung / brain infarction. - Patients having a pronounced hemorrhagic lesion. |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Kissei Pharmaceutical Co., Ltd. | JCR Pharmaceuticals Co., Ltd. |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from baseline in Hemoglobin level | 24 weeks |
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