Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will assess the efficacy and safety of Mircera given intravenously in the treatment of renal anemia in chronic kidney disease patients on dialysis who are not currently 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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| epoetin | Drug | 3 times a week iv, as prescribed. |
| |
| methoxy polyethylene glycol-epoetin beta [Mircera] |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin response rate | Weeks 1-24 |
| Measure | Description | Time Frame |
|---|---|---|
| Hb over time, time to target Hb response, incidence of RBC transfusions. Vital signs, ECG, AEs, laboratory values\n | Throughout study |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Davis | California | 95616 | 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. | |
| 18037099 | Derived | Klinger M, Arias M, Vargemezis V, Besarab A, Sulowicz W, Gerntholtz T, Ciechanowski K, Dougherty FC, Beyer U. Efficacy of intravenous methoxy polyethylene glycol-epoetin beta administered every 2 weeks compared with epoetin administered 3 times weekly in patients treated by hemodialysis or peritoneal dialysis: a randomized trial. Am J Kidney Dis. 2007 Dec;50(6):989-1000. doi: 10.1053/j.ajkd.2007.08.013. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
0.4 micrograms/kg iv (starting dose) once every 2 weeks |
|
| Lakewood |
| Colorado |
| 80260 |
| United States |
| Atlanta | Georgia | 30342 | United States |
| Augusta | Georgia | 30901 | United States |
| New Orleans | Louisiana | 70112 | United States |
| Boston | Massachusetts | 02115 | United States |
| Springfield | Massachusetts | 01107 | United States |
| Detroit | Michigan | 48202-2689 | United States |
| Mineola | New York | 11501 | United States |
| New York | New York | 10128 | United States |
| Toledo | Ohio | 43606 | United States |
| Houston | Texas | 77054 | United States |
| Burlington | Vermont | 05401 | United States |
| Norfolk | Virginia | 23507-1901 | United States |
| Curitiba | 81050-090 | Brazil |
| Ribeirão Preto | 14025-170 | Brazil |
| São Paulo | 01307-001 | Brazil |
| São Paulo | 04039-000 | Brazil |
| Calgary | Alberta | T2N 2T9 | Canada |
| Vancouver | British Columbia | V5Z 1M9 | Canada |
| Winnipeg | Manitoba | R3A 1R9 | Canada |
| St. John's | Newfoundland and Labrador | A1B 3V6 | Canada |
| Kingston | Ontario | K7L 3N6 | Canada |
| London | Ontario | N6A 5A5 | Canada |
| Toronto | Ontario | M5G 2C4 | Canada |
| Montreal | Quebec | H3A 1A1 | Canada |
| Saskatoon | Saskatchewan | S7K 1N4 | Canada |
| Liberec | 460 63 | Czechia |
| Prague | 169 00 | Czechia |
| Ústí nad Labem | 401 13 | Czechia |
| Alexandroupoli | 68100 | Greece |
| Larissa | 41 110 | Greece |
| Nikaia | 18354 | Greece |
| Thessaloniki | 54629 | Greece |
| Bergen | 5021 | Norway |
| Oslo | 0407 | Norway |
| Gdansk | 80-211 | Poland |
| Gdynia | 81-519 | Poland |
| Krakow | 31-501 | Poland |
| Lodz | 90-153 | Poland |
| Poznan | 60-355 | Poland |
| Szczecin | 70-111 | Poland |
| Wołomin | 05-200 | Poland |
| Wroclaw | 50-417 | Poland |
| Moscow | 123182 | Russia |
| Moscow | 125101 | Russia |
| Moscow | 129110 | Russia |
| Saint Petersburg | 195067 | Russia |
| Saint Petersburg | 197089 | Russia |
| Johannesburg | 2193 | South Africa |
| Soweto | South Africa |
| Bilbao | 48013 | Spain |
| Santander | 39008 | Spain |
| Karlstad | 65185 | Sweden |
| Lausanne | 1011 | Switzerland |
| Bangkok | 10700 | Thailand |
| Bangkok | Thailand |
| Chiang Mai | 50200 | Thailand |
| Chon Buri | Thailand |
| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D004921 | Erythropoietin |
| C508420 | continuous erythropoietin receptor activator |
| ID | Term |
|---|---|
| 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 |
Not provided
Not provided