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Sponsored by: |
Hoffmann-La Roche |
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Information provided by: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT00642304 |
This single arm study will assess the efficacy and safety of subcutaneous Mircera when administered for the maintenance of hemoglobin levels in patients with chronic renal anemia, not on dialysis. Patients currently receiving maintenance treatment with subcutaneous darbepoetin alfa or epoetin beta will receive monthly injections of Mircera, with the starting dose (120, 200 or 360 micrograms s.c.) derived from the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding study start. 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 |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Single Arm Open Label Study to Assess Efficacy, Safety and Tolerability of Once-Monthly Administration of Subcutaneously Mircera for the Maintenance of Hemoglobin Levels in Patients With Chronic Renal Anemia Not on Dialysis |
Estimated Enrollment: | 200 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | February 2010 |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
120, 200 or 360 micrograms sc monthly (starting dose)
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Please reference Study ID Number: ML20937 | 973-235-5000 | |
Contact: or | 800-526-6367 (FOR US ONLY) |
Netherlands | |
Recruiting | |
MAASTRICHT, Netherlands, 6202 | |
Recruiting | |
HOOGEVEEN, Netherlands, 7909 | |
Recruiting | |
UTRECHT, Netherlands, 3582 KE | |
Recruiting | |
GOUDA, Netherlands, 2803 HH | |
Recruiting | |
ROTTERDAM, Netherlands, 3083 AN | |
Recruiting | |
ROTTERDAM, Netherlands, 3078 HT | |
Recruiting | |
DRACHTEN, Netherlands, 9202 NN | |
Terminated | |
BEVERWIJK, Netherlands, 1942LE | |
Recruiting | |
DOETINCHEM, Netherlands, 7009 BL | |
Recruiting | |
ALMELO, Netherlands, 7600 SZ | |
Recruiting | |
NIJMEGEN, Netherlands, 6525 GA | |
Recruiting | |
TERNEUZEN, Netherlands, 4535 PA | |
Recruiting | |
ROTTERDAM, Netherlands, 3015 GD | |
Recruiting | |
AMERSFOORT, Netherlands, 3800 BM | |
Recruiting | |
BREDA, Netherlands, 4818 CK | |
Recruiting | |
DELFT, Netherlands, 2625 AD | |
Terminated | |
LEIDERDORP, Netherlands, 2353 GA | |
Recruiting | |
GOES, Netherlands, 4462 RA | |
Recruiting | |
AMSTERDAM, Netherlands, 1034 CS | |
Recruiting | |
HEERLEN, Netherlands, 6419 PC | |
Recruiting | |
LEIDEN, Netherlands, 2333 ZA | |
Recruiting | |
DORDRECHT, Netherlands, 3318 AT | |
Recruiting | |
ASSEN, Netherlands, 9401 RK |
Study Director: | Clinical Trials | Hoffmann-La Roche, +1 973 235 5000 |
Responsible Party: | Hoffmann-La Roche ( Clinical Trials, Study Director ) |
Study ID Numbers: | ML20937 |
Study First Received: | March 19, 2008 |
Last Updated: | April 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00642304 History of Changes |
Health Authority: | Netherlands:Medicines Evaluation Board |
Epoetin Alfa Hematologic Diseases Anemia |
Hematologic Diseases Anemia |