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This study will assess the efficacy and safety of subcutaneous Mircera in the treatment of renal anemia in patients with chronic kidney disease who are not on dialysis and not receiving epoetin or any other erythropoietic substance. The anticipated time on study treatment is 1-2 years 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 |
|---|---|---|---|---|
| darbepoetin alfa | Drug | 0.45 micrograms/kg sc (starting dose) weekly |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin response rate | Weeks 1-28 |
| Measure | Description | Time Frame |
|---|---|---|
| Hb concentration over time, time to target Hb response, incidence of RBC transfusions. Vital signs, ECG, adverse events, laboratory values\n\n | 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 |
|---|---|---|---|---|---|---|
| Los Angeles | California | 90073 | 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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| methoxy polyethylene glycol-epoetin beta [Mircera] |
| Drug |
0.6 micrograms/kg sc (starting dose) once every 2 weeks |
|
| Mather |
| California |
| 95655 |
| United States |
| Stanford | California | 94305-5114 | United States |
| Stamford | Connecticut | 06902 | United States |
| Bay Pines | Florida | 33744 | United States |
| Ocala | Florida | 34471 | United States |
| Shreveport | Louisiana | 71101 | United States |
| Boston | Massachusetts | 02135 | United States |
| Boston | Massachusetts | 02215 | United States |
| Detroit | Michigan | 48236 | United States |
| Flushing | New York | 11355 | United States |
| Cincinnati | Ohio | 45220 | United States |
| Portland | Oregon | 97201-2940 | United States |
| Allentown | Pennsylvania | 18103 | United States |
| Columbia | South Carolina | 29209 | United States |
| Nashville | Tennessee | 37232 | United States |
| Austin | Texas | 78705 | United States |
| Dallas | Texas | 75216 | United States |
| Houston | Texas | 77054 | United States |
| Burlington | Vermont | 05401 | United States |
| Salem | Virginia | 24153 | United States |
| Morgantown | West Virginia | 26506 | United States |
| Clayton | 3186 | Australia |
| Liverpool | 1871 | Australia |
| Parkville | 3052 | Australia |
| Perth | 6847 | Australia |
| Antwerp | 2060 | Belgium |
| Leuven | 3000 | Belgium |
| Calgary | Alberta | T2N 2T9 | Canada |
| Edmonton | Alberta | T6G 2B7 | Canada |
| Kamloops | British Columbia | V2C 2T1 | Canada |
| New Westminster | British Columbia | V3L 3W7 | Canada |
| Vancouver | British Columbia | V6Z 1Y6 | Canada |
| Winnipeg | Manitoba | R2H 2A6 | Canada |
| St. John's | Newfoundland and Labrador | A1B 3V6 | Canada |
| Kitchener | Ontario | N2G 1N9 | Canada |
| London | Ontario | N6A 5A5 | Canada |
| Scarborough Village | Ontario | M1H 3G4 | Canada |
| Toronto | Ontario | M4N 3M5 | Canada |
| Toronto | Ontario | M5G 2C4 | Canada |
| Montreal | Quebec | H1T 2M4 | Canada |
| Montreal | Quebec | H3A 1A1 | Canada |
| Saskatoon | Saskatchewan | S7K 1N4 | Canada |
| Angers | 49933 | France |
| Besançon | 25030 | France |
| Chartres | 28000 | France |
| Colmar | 68024 | France |
| Lille | 59037 | France |
| Lyon | 69437 | France |
| Nantes | 44035 | France |
| Paris | 75743 | France |
| Paris | 75908 | France |
| Perpignan | 66046 | France |
| Salouël | 80480 | France |
| Toulouse | 31059 | France |
| Vandœuvre-lès-Nancy | 54511 | France |
| Aschaffenburg | 63741 | Germany |
| Berlin | 13353 | Germany |
| Bonn | 53127 | Germany |
| Dortmund | 44263 | Germany |
| Düsseldorf | 40225 | Germany |
| Tübingen | 72076 | Germany |
| Alexandroupoli | 68100 | Greece |
| Athens | 11527 | Greece |
| Ioannina | 455 00 | Greece |
| Piraeus | 18536 | Greece |
| Thessaloniki | 54629 | Greece |
| Cagliari | 91034 | Italy |
| Cuneo | 12100 | Italy |
| Genova | 16132 | Italy |
| Lecco | 23900 | Italy |
| Lodi | 26900 | Italy |
| Modena | 41100 | Italy |
| Naples | 80131 | Italy |
| Padova | 35128 | Italy |
| Pavia | 27100 | Italy |
| Prato | 50047 | Italy |
| Reggio Calabria | 89124 | Italy |
| Roma | 00184 | Italy |
| Amersfoort | 3818 | Netherlands |
| Heerlen | 6419 PC | Netherlands |
| San Juan | 00936-5067 | Puerto Rico |
| Almería | 04009 | Spain |
| Barcelona | 08907 | Spain |
| Lleida | 25198 | Spain |
| Madrid | 28041 | Spain |
| Madrid | 28046 | Spain |
| Madrid | 28805 | Spain |
| Palma de Mallorca | 07014 | Spain |
| Valencia | 46017 | Spain |
| Borås | 50142 | Sweden |
| Umeå | 90185 | Sweden |
| Birmingham | B9 5SS | United Kingdom |
| Carshalton | SM5 1AA | United Kingdom |
| Leicester | LE5 4PW | United Kingdom |
| London | SE1 9RT | United Kingdom |
| London | SE22 8PT | United Kingdom |
| London | SW17 0RE | United Kingdom |
| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000068256 | Darbepoetin alfa |
| C508420 | continuous erythropoietin receptor activator |
| 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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