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| Sponsored by: |
Hoffmann-La Roche |
| Information provided by: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00576628 |
Purpose
This single arm study will assess the efficacy, safety and tolerability of subcutaneous Mircera for correction of anemia and maintenance of hemoglobin levels in patients with chronic kidney disease who are not on dialysis and are not treated with ESA. Eligible patients will receive Mircera by monthly subcutaneous injections, dependent on body weight (with a recommended starting dose of 1.2 micrograms/kg). The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
| Condition | Intervention | Phase |
|
Anemia |
Drug: methoxy polyethylene glycol-epoetin beta [Mircera] |
Phase III |
| MedlinePlus related topics: | Anemia |
| ChemIDplus related topics: | Epoetin alfa Erythropoietin Epoetin beta |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | An Open Label Study to Assess the Effect on Anemia Correction, Maintenance of Haemoglobin Levels, Safety and Tolerability of Monthly Administration of Subcutaneous Mircera in Pre-Dialysis Patients With Chronic Renal Anemia Not Currently Treated With ESA. |
| Estimated Enrollment: | 200 |
| Study Start Date: | April 2008 |
| Estimated Study Completion Date: | February 2010 |
| Arms | Assigned Interventions |
| 1: Experimental |
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Recommended starting dose 1.2 micrograms/kg sc monthly
|
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| Contact: Please reference Study ID Number: RLI_ML20978 | 973-235-5000 | |
| Contact: or | 800-526-6367 (FOR US ONLY) |
| Russian Federation | |||||
| Recruiting | |||||
| ROSTOV-NA-DONU, Russian Federation, 344029 | |||||
| Recruiting | |||||
| ST PETERSBURG, Russian Federation, 195067 | |||||
| Recruiting | |||||
| NIZHNY NOVGOROD, Russian Federation, 603001 | |||||
| Active, not recruiting | |||||
| MOSCOW, Russian Federation, 129110 | |||||
| Recruiting | |||||
| OMSK, Russian Federation, 644112 | |||||
| Recruiting | |||||
| SARATOV, Russian Federation, 410053 | |||||
| Recruiting | |||||
| IRKUTSK, Russian Federation, 664079 | |||||
| Recruiting | |||||
| TJUMEN, Russian Federation, 625023 | |||||
| Recruiting | |||||
| ORENBURG, Russian Federation, 460018 | |||||
| Recruiting | |||||
| EKATERINBURG, Russian Federation, 620102 | |||||
| Not yet recruiting | |||||
| KHABAROVSK, Russian Federation, 680009 | |||||
| Recruiting | |||||
| NIZHNY NOVGOROD, Russian Federation, 603126 | |||||
| Recruiting | |||||
| MOSCOW, Russian Federation, 117036 | |||||
| Recruiting | |||||
| MOSCOW, Russian Federation, 125315 | |||||
| Recruiting | |||||
| ST PETERSBURG, Russian Federation, 194354 | |||||
| Recruiting | |||||
| MOSCOW, Russian Federation, 125101 | |||||
| Recruiting | |||||
| MOSCOW, Russian Federation, 123182 | |||||
| Recruiting | |||||
| KHANTY-MANSIYSK, Russian Federation, 628011 | |||||
| Recruiting | |||||
| ST PETERSBURG, Russian Federation, 197089 | |||||
| Recruiting | |||||
| UFA, Russian Federation, 450005 | |||||
| Hoffmann-La Roche |
| 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: | ML20978 |
| First Received: | December 18, 2007 |
| Last Updated: | August 18, 2008 |
| ClinicalTrials.gov Identifier: | NCT00576628 |
| Health Authority: | Russia: Federal Agency of Drug Quality Control |
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