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Sponsored by: |
Hoffmann-La Roche |
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Information provided by: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT00048048 |
This study will evaluate the efficacy and safety of different subcutaneous starting doses and dosing frequencies of Mircera in anemic patients with chronic kidney disease not yet on dialysis. The anticipated time on study treatment is 3-12 months and the target sample size is <100 individuals.
Condition | Intervention | Phase |
---|---|---|
Anemia |
Drug: methoxy polyethylene glycol-epoetin beta [Mircera] |
Phase II |
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 Different Dosing Intervals of Subcutaneous Mircera on Hemoglobin Level/Correction in Patients With Chronic Renal Anemia |
Enrollment: | 65 |
Study Completion Date: | March 2006 |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Differing doses and frequencies of sc administration
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2: Experimental |
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Differing doses and frequencies of sc administration
|
3: Experimental |
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Differing doses and frequencies of sc administration
|
4: Experimental |
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Differing doses and frequencies of sc administration
|
5: Experimental |
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Differing doses and frequencies of sc administration
|
6: Experimental |
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Differing doses and frequencies of sc administration
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7: Experimental |
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Differing doses and frequencies of sc administration
|
8: Experimental |
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Differing doses and frequencies of sc administration
|
9: Experimental |
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Differing doses and frequencies of sc administration
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Alabama | |
BIRMINGHAM, Alabama, United States, 35211 | |
United States, California | |
SAN DIEGO, California, United States, 92103-8342 | |
United States, Michigan | |
DETROIT, Michigan, United States, 48202-2689 | |
DETROIT, Michigan, United States, 48236 | |
United States, Nevada | |
LAS VEGAS, Nevada, United States, 89106 | |
RENO, Nevada, United States, 89434 | |
United States, New York | |
MINEOLA, New York, United States, 11501 | |
United States, Oregon | |
PORTLAND, Oregon, United States, 97201-2940 | |
Canada, Alberta | |
EDMONTON, Alberta, Canada, T6G 2B7 | |
Canada, British Columbia | |
VANCOUVER, British Columbia, Canada, V6Z 1Y6 | |
Canada, Quebec | |
MONTREAL, Quebec, Canada, H3A 1A1 | |
France | |
PARIS, France, 75018 | |
COLMAR, France, 68024 | |
PARIS, France, 75475 | |
Mexico | |
MONTERREY, Mexico, 64710 | |
MEXICO CITY, Mexico, 14000 | |
Poland | |
WROCLAW, Poland, 50-417 | |
GDANSK, Poland, 80-211 | |
KRAKOW, Poland, 31-501 | |
United Kingdom | |
LONDON, United Kingdom, SE22 8PT | |
BELFAST, United Kingdom, BT9 7LJ |
Study Director: | Clinical Trials | Hoffmann-La Roche, +1 973 235 5000 |
Responsible Party: | Hoffmann-La Roche ( Clinical Trials, Study Director ) |
Study ID Numbers: | BA16528 |
Study First Received: | October 24, 2002 |
Last Updated: | May 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00048048 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Epoetin Alfa Hematologic Diseases Renal Insufficiency, Chronic |
Anemia Kidney Failure, Chronic Kidney Diseases |
Hematologic Diseases Anemia |