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Sponsored by: |
Hoffmann-La Roche |
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Information provided by: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT00605293 |
This 2 arm study will compare the efficacy and safety of monthly administration of intravenous Mircera versus epoetin alfa for the maintenance of hemoglobin levels in hemodialysis patients with chronic renal anemia. Patients currently receiving maintenance treatment with epoetin alfa will be randomized either to receive monthly injections of 120, 200 or 360 micrograms Mircera, with the starting dose derived from the dose of epoetin alfa they were receiving in the week preceding study start, or to continue on epoetin alfa treatment. 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] Drug: Epoetin alfa |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | An Open Label Randomised Controlled Study to Compare the Efficacy, Safety and Tolerability of Once-Monthly Administration of Intravenous C.E.R.A. Versus Epoetin Alfa for the Maintenance of Haemoglobin Levels in Dialysis Patients With Chronic Renal Anaemia |
Estimated Enrollment: | 297 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | January 2010 |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
120, 200 or 360 micrograms iv/month (starting dose)
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2: Active Comparator |
Drug: Epoetin alfa
As prescribed
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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: ML21060 | 973-235-5000 | |
Contact: or | 800-526-6367 (FOR US ONLY) |
Spain | |
Recruiting | |
MADRID, Spain, 28041 | |
Recruiting | |
VALENCIA, Spain, 46009 | |
Recruiting | |
ZARAGOZA, Spain, 50009 | |
Recruiting | |
SALAMANCA, Spain, 37008 | |
Recruiting | |
BARCELONA, Spain, 08035 | |
Recruiting | |
VALENCIA, Spain, 46010 | |
Recruiting | |
HUELVA, Spain, 21005 | |
Recruiting | |
CIUDAD REAL, Spain, 13005 | |
Recruiting | |
MADRID, Spain, 28034 | |
Recruiting | |
MADRID, Spain, 28905 | |
Recruiting | |
MARBELLA, Spain, 296000 | |
Recruiting | |
CASTELLON, Spain, 12004 | |
Recruiting | |
BADAJOZ, Spain, 06300 | |
Recruiting | |
PONTEVEDRA, Spain, 36071 | |
Recruiting | |
ZAMORA, Spain, 49022 | |
Recruiting | |
TERUEL, Spain, 444600 | |
Recruiting | |
TUDELA, Spain, 46010 | |
Recruiting | |
CACERES, Spain, 10310 |
Study Director: | Clinical Trials | Hoffmann-La Roche, +1 973 235 5000 |
Responsible Party: | Hoffmann-La Roche ( Clinical Trials, Study Director ) |
Study ID Numbers: | ML21060 |
Study First Received: | January 18, 2008 |
Last Updated: | December 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00605293 |
Health Authority: | Spain: Sanitarios |
Epoetin Alfa Hematologic Diseases Anemia |
Hematinics Therapeutic Uses Hematologic Agents Pharmacologic Actions |