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This study will evaluate the tolerability, and effect on quality of life, in patients receiving multi-dose NeoRecormon administered by RecoPen in predialysis patients with chronic renal anemia. The anticipated time on study treatment is 10 months, and the target sample size is 60 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epoetin Beta | Experimental | Patients will be administered 3 times (X) 30 International unis per kilogram(IU/Kg body weight per week of eopetin beta subcurtaneously using the device RecoPen. The dosage could be increased every 4 weeks by 3 X20 IU/Kg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epoetin Beta | Drug | Initial dose: 3X30 IU/Kg body weight administered subcutaneously using RecoPen. Dosage could be increased by 3X20 IU/Kg every 4 weeks up to a maximum of 720 IU/Kg per week. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participantss who change to once weekly NeoRocormon | 10 months | |
| Percentage of participants with local intolerabilities (pain/allergic reactions) | 10 months | |
| Percentage of participants who withdrew due to inability to use RecoPen | 10 months | |
| Percentage of participants who changed dose during treatmnent | 10 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life evaluated by the Short Form 36 | 10 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sofia | 1233 | Bulgaria | ||||
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| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C103998 | epoetin beta |
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| Sofia |
| 1431 |
| Bulgaria |
| Sofia | 1504 | Bulgaria |
| Varna | 9002 | Bulgaria |