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| ID | Type | Description | Link |
|---|---|---|---|
| UMIN000013464 | Registry Identifier | UMIN-CTR |
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| Name | Class |
|---|---|
| Niigata University | UNKNOWN |
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This is an observational clinical research on patients with chronic kidney disease who are not on hemodialysis and receiving darbepoetin alfa to treat diagnosed renal anemia; the major objective is to explore novel erythropoiesis stimulating agent (ESA) response index in association with deterioration of renal function as well as occurrence of cardiovascular disease events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Darbepoetin alfa |
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| Measure | Description | Time Frame |
|---|---|---|
| Deterioration of renal function | For ninety six weeks after starting to administer darbepoetin alfa | |
| Cardiovascular disease events | For ninety six weeks after starting to administer darbepoetin alfa |
| Measure | Description | Time Frame |
|---|---|---|
| Declination rate of estimated glomerular filtration rate(eGFR) | For ninety six weeks after starting to administer darbepoetin alfa | |
| Safety assessment for every adverse event resulting from darbepoetin alfa administration | For ninety six weeks after starting to administer darbepoetin alfa |
| Measure | Description | Time Frame |
|---|---|---|
| Erythropoiesis resistance index (ERI) | For ninety six weeks after starting to administer darbepoetin alfa |
Inclusion Criteria:
Exclusion Criteria:
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Chronic renal disease patients without dialysis who are diagnosed with renal anemia and are administered darbepoetin alfa at enrollment
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| Name | Affiliation | Role |
|---|---|---|
| Ichiei Narita | Niigata University Graduate School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Niigata University Graduate School of Medicine | Niigata | 950-2181 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38941000 | Derived | Nakai K, Nishino T, Kagimura T, Narita I. Impact of transferrin saturation on cardiovascular events in non-dialysis-dependent chronic kidney disease patients treated with darbepoetin alfa. J Nephrol. 2024 Nov;37(8):2327-2335. doi: 10.1007/s40620-024-02000-y. Epub 2024 Jun 28. |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |