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| Sponsor: | Hoffmann-La Roche |
|---|---|
| Information provided by: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00081471 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Anemia |
Drug: methoxy polyethylene glycol-epoetin beta [Mircera] Drug: darbepoetin alfa |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized, Open-Label Study of the Effect of Subcutaneous Mircera on Hemoglobin Level/Correction in Non-Dialysis Patients With Chronic Kidney Disease |
| Enrollment: | 324 |
| Study Completion Date: | July 2006 |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
0.6 micrograms/kg sc (starting dose) once every 2 weeks
|
| 2: Active Comparator |
Drug: darbepoetin alfa
0.45 micrograms/kg sc (starting dose) weekly
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, California | |
| STANFORD, California, United States, 94305-5114 | |
| MATHER, California, United States, 95655 | |
| LOS ANGELES, California, United States, 90073 | |
| United States, Connecticut | |
| STAMFORD, Connecticut, United States, 06902 | |
| United States, Florida | |
| OCALA, Florida, United States, 34471 | |
| BAY PINES, Florida, United States, 33744 | |
| United States, Louisiana | |
| SHREVEPORT, Louisiana, United States, 71101 | |
| United States, Massachusetts | |
| BOSTON, Massachusetts, United States, 02215 | |
| BOSTON, Massachusetts, United States, 02135 | |
| United States, Michigan | |
| DETROIT, Michigan, United States, 48236 | |
| United States, New York | |
| FLUSHING, New York, United States, 11355 | |
| United States, Ohio | |
| CINCINNATI, Ohio, United States, 45220 | |
| United States, Oregon | |
| PORTLAND, Oregon, United States, 97201-2940 | |
| United States, Pennsylvania | |
| ALLENTOWN, Pennsylvania, United States, 18103 | |
| United States, South Carolina | |
| COLUMBIA, South Carolina, United States, 29209 | |
| United States, Tennessee | |
| NASHVILLE, Tennessee, United States, 37232 | |
| United States, Texas | |
| AUSTIN, Texas, United States, 78705 | |
| HOUSTON, Texas, United States, 77054 | |
| DALLAS, Texas, United States, 75216 | |
| United States, Vermont | |
| BURLINGTON, Vermont, United States, 05401 | |
| United States, Virginia | |
| SALEM, Virginia, United States, 24153 | |
| United States, West Virginia | |
| MORGANTOWN, West Virginia, United States, 26506 | |
| Australia | |
| PERTH, Australia, 6847 | |
| PARKVILLE, Australia, 3052 | |
| MELBOURNE, Australia, 3168 | |
| LIVERPOOL, Australia, 1871 | |
| Belgium | |
| LEUVEN, Belgium, 3000 | |
| ANTWERPEN, Belgium, 2060 | |
| Canada, Alberta | |
| CALGARY, Alberta, Canada, T2N 2T9 | |
| EDMONTON, Alberta, Canada, T6G 2B7 | |
| Canada, British Columbia | |
| KAMLOOPS, British Columbia, Canada, V2C 2T1 | |
| VANCOUVER, British Columbia, Canada, V6Z 1Y6 | |
| NEW WESTMINSTER, British Columbia, Canada, V3L 3W7 | |
| Canada, Manitoba | |
| WINNIPEG, Manitoba, Canada, R2H 2A6 | |
| Canada, Newfoundland and Labrador | |
| ST JOHN'S, Newfoundland and Labrador, Canada, A1B 3V6 | |
| Canada, Ontario | |
| TORONTO, Ontario, Canada, M5G 2C4 | |
| KITCHENER, Ontario, Canada, N2G 1N9 | |
| TORONTO, Ontario, Canada, M4N 3M5 | |
| LONDON, Ontario, Canada, N6A 5A5 | |
| SCARBOROUGH, Ontario, Canada, M1H 3G4 | |
| Canada, Quebec | |
| MONTREAL, Quebec, Canada, H3A 1A1 | |
| MONTREAL, Quebec, Canada, H1T 2M4 | |
| Canada, Saskatchewan | |
| SASKATOON, Saskatchewan, Canada, S7K 1N4 | |
| France | |
| BESANCON, France, 25030 | |
| AMIENS, France, 80054 | |
| NANTES, France, 44035 | |
| PARIS, France, 75743 | |
| PARIS, France, 75908 | |
| VANDOEUVRE-LES-NANCY, France, 54511 | |
| LYON, France, 69437 | |
| COLMAR, France, 68024 | |
| TOULOUSE, France, 31054 | |
| LILLE, France, 59037 | |
| ANGERS, France, 49933 | |
| CHARTRES, France, 28000 | |
| PERPIGNAN, France, 66046 | |
| Germany | |
| DORTMUND, Germany, 44263 | |
| TÜBINGEN, Germany, 72076 | |
| DÜSSELDORF, Germany, 40225 | |
| BONN, Germany, 53127 | |
| ASCHAFFENBURG, Germany, 63741 | |
| BERLIN, Germany, 13353 | |
| Greece | |
| THESSALONIKI, Greece, 54629 | |
| ALEXANDROUPOLIS, Greece, 68100 | |
| IOANNINA, Greece, 45500 | |
| ATHENS, Greece, 11527 | |
| PIRAEUS, Greece, 18536 | |
| Italy | |
| LECCO, Italy, 23900 | |
| ROMA, Italy, 00184 | |
| MODENA, Italy, 41100 | |
| CAGLIARI, Italy, 09134 | |
| PRATO, Italy, 50047 | |
| LODI, Italy, 26900 | |
| PAVIA, Italy, 27100 | |
| CUNEO, Italy, 12100 | |
| NAPOLI, Italy, 80131 | |
| GENOVA, Italy, 16132 | |
| PADOVA, Italy, 35128 | |
| REGGIO CALABRIA, Italy, 89124 | |
| Netherlands | |
| AMERSFOORT, Netherlands, 3818 | |
| HEERLEN, Netherlands, 6419 PC | |
| Puerto Rico | |
| SAN JUAN, Puerto Rico, 00936-5067 | |
| Spain | |
| MADRID, Spain, 28046 | |
| VALENCIA, Spain, 46017 | |
| BARCELONA, Spain, 08907 | |
| MADRID, Spain, 28041 | |
| PALMA DE MALLORCA, Spain, 07014 | |
| MADRID, Spain, 28805 | |
| LERIDA, Spain, 25198 | |
| ALMERÍA, Spain, 04009 | |
| Sweden | |
| BORAS, Sweden, 50142 | |
| UMEA, Sweden, 90185 | |
| United Kingdom | |
| CARSHALTON, United Kingdom, SM5 1AA | |
| LEICESTER, United Kingdom, LE5 4PW | |
| LONDON, United Kingdom, SE22 8PT | |
| LONDON, United Kingdom, SW17 0RE | |
| BIRMINGHAM, United Kingdom, B9 5SS | |
| LONDON, United Kingdom, SE1 9RT | |
| Study Director: | Clinical Trials | Hoffmann-La Roche, +1 973 235 5000 |
More Information
| Responsible Party: | Hoffmann-La Roche ( Clinical Trials, Study Director ) |
| Study ID Numbers: | BA16738 |
| Study First Received: | April 13, 2004 |
| Last Updated: | May 13, 2009 |
| ClinicalTrials.gov Identifier: | NCT00081471 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Renal Insufficiency Hematologic Diseases Hematinics Hematologic Agents Anemia Kidney Failure, Chronic Darbepoetin alfa |
Pharmacologic Actions Urologic Diseases Renal Insufficiency, Chronic Therapeutic Uses Kidney Diseases Kidney Failure |
