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This study will assess the efficacy and safety of intravenous (iv) or subcutaneous (sc) Mircera, administered with pre-filled syringes, as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv or sc epoetin. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| epoetin alfa or beta | Drug | iv or sc, as prescribed |
| |
| methoxy polyethylene glycol-epoetin beta [Mircera] |
| Measure | Description | Time Frame |
|---|---|---|
| Change in hemoglobin concentration | Weeks 1-36 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients maintaining average Hb concentration within +/- 1g/dL of average baseline Hb concentration | Weeks 29-36 | |
| RBC transfusions | Weeks 1-36 | |
| AEs, laboratory parameters, vital signs |
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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 |
|---|---|---|---|---|---|---|
| Covina | California | 91723 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36791280 | Derived | Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3. |
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| Drug |
30, 50 or 90 micrograms iv or sc (starting dose) every 2 weeks |
|
| Throughout study |
| Los Alamitos |
| California |
| 90720 |
| United States |
| Los Angeles | California | 90073 | United States |
| San Diego | California | 92123 | United States |
| San Diego | California | 92161 | United States |
| Tampa | Florida | 33617 | United States |
| Honolulu | Hawaii | 96813 | United States |
| South Holland | Illinois | 60473 | United States |
| Baton Rouge | Louisiana | 70884 | United States |
| Shreveport | Louisiana | 71101 | United States |
| Shreveport | Louisiana | 71103 | United States |
| Boston | Massachusetts | 02135 | United States |
| Kalamazoo | Michigan | 49007 | United States |
| Columbus | Mississippi | 39705 | United States |
| Tupelo | Mississippi | 38801 | United States |
| St Louis | Missouri | 63128 | United States |
| Hackensack | New Jersey | 07601 | United States |
| Flushing | New York | 11355 | United States |
| New York | New York | 10025 | United States |
| Orchard Park | New York | 14127 | United States |
| Cleveland | Ohio | 44109 | United States |
| Cleveland | Ohio | 44195 | United States |
| Oregon City | Oregon | 97045 | United States |
| Erie | Pennsylvania | 16502 | United States |
| Lewistown | Pennsylvania | 17044 | United States |
| Philadelphia | Pennsylvania | 19106 | United States |
| Philadelphia | Pennsylvania | 19140 | United States |
| Philadelphia | Pennsylvania | 19141 | United States |
| Columbia | South Carolina | 29209 | United States |
| Charlottesville | Virginia | 22908 | United States |
| Norfolk | Virginia | 23507-1901 | United States |
| Ottawa | Ontario | K1H 7W9 | Canada |
| Toronto | Ontario | M5G 2C4 | Canada |
| Greenfield Park | Quebec | J4V 2H1 | Canada |
| Montreal | Quebec | H3G 1A4 | Canada |
| Aix-en-Provence | 13616 | France |
| Chambéry | 73011 | France |
| Hyères | 83400 | France |
| Le Kremlin-Bicêtre | 94275 | France |
| Nantes | 44093 | France |
| Paris | 75970 | France |
| Rouen | 76031 | France |
| Erlangen | 91054 | Germany |
| München | 80804 | Germany |
| Nuremberg | 90431 | Germany |
| Como | 22100 | Italy |
| Modena | 41100 | Italy |
| Pavia | 27100 | Italy |
| Rzeszów | 35-055 | Poland |
| Warsaw | 02-006 | Poland |
| Carnaxide | 2799-523 | Portugal |
| Porto | 4099-001 | Portugal |
| Setúbal | 2910-446 | Portugal |
| Ponce | 00732 | Puerto Rico |
| San Juan | 00936-5067 | Puerto Rico |
| Alicante | 03010 | Spain |
| Madrid | 28007 | Spain |
| Kaohsiung City | 833 | Taiwan |
| Taichung | 407 | Taiwan |
| Taipei | 100 | Taiwan |
| Bangkok | Thailand |
| Glasgow | G4 OSF | United Kingdom |
| Hertford | SG1 4AB | United Kingdom |
| London | E1 1BB | United Kingdom |
| Salford | M6 8HD | United Kingdom |
| Swansea | SA6 6NL | United Kingdom |
| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000068817 | Epoetin Alfa |
| C508420 | continuous erythropoietin receptor activator |
| ID | Term |
|---|---|
| D004921 | Erythropoietin |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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