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This study will assess the comfort of subcutaneous injections of NeoRecormon and darbepoetin alfa (Aranesp) in patients with renal anemia. Eligible patients will be randomized to receive comparable subcutaneous injections of either darbepoetin alfa (30 micrograms) or NeoRecormon (6000IU). They will then be crossed over to the alternative treatment arm for further treatment. After each injection pain will be assessed using the visual analogue scale (VAS) and 6-point verbal rating scale (VRS), and patient preference will be assessed. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| darbepoetin alfa | Drug | 30 micrograms sc weekly (2 doses) |
| |
| epoetin beta [NeoRecormon] |
| Measure | Description | Time Frame |
|---|---|---|
| Local pain due to s.c. injection (by VAS). | After each injection |
| Measure | Description | Time Frame |
|---|---|---|
| Patient preference. | At end of study | |
| AEs, vital signs. | Throughout study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Adelaide | 5011 | Australia | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18565240 | Derived | Roger SD, Suranyi MG, Walker RG, Disney A, Isbel NM, Kairaitis L, Pollock CA, Brown FG, Chow J, Truman MI, Ulyate KA; COMFORT study group. A randomised, cross-over study comparing injection site pain with subcutaneous epoetin beta and subcutaneous darbepoetin alfa in patients with chronic kidney disease. Curr Med Res Opin. 2008 Aug;24(8):2181-7. doi: 10.1185/03007990802240552. Epub 2008 Jun 18. |
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| Drug |
6000 IU sc weekly (2 doses) |
|
| Gosford |
| 2250 |
| Australia |
| Liverpool | 2170 | Australia |
| Melbourne | 3168 | Australia |
| Parkville | 3052 | Australia |
| St Leonards | 2065 | Australia |
| Sydney | NSW 2148 | Australia |
| Woolloongabba | 4102 | Australia |
| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000068256 | Darbepoetin alfa |
| C103998 | epoetin beta |
| ID | Term |
|---|---|
| D004921 | Erythropoietin |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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