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A Study of Subcutaneous Mircera for the Treatment of Anemia in Dialysis Patients.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00077623
First received: February 10, 2004
Last updated: May 23, 2013
Last verified: May 2013
History of Changes
  Purpose

This study will assess the efficacy and safety of subcutaneous (sc) Mircera given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving sc epoetin. 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: epoetin alfa or beta
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-label Study of the Effect of Maintenance Subcutaneous Mircera on Hemoglobin Levels in Dialysis Patients With Chronic Kidney Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Change in hemoglobin concentration [ Time Frame: Weeks 1-36 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of patients maintaining average Hb concentration within +/- 1g/dL of average baseline Hb concentration\n [ Time Frame: Weeks 29-36 ] [ Designated as safety issue: No ]
  • RBC transfusions [ Time Frame: Weeks 1-36 ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters, vital signs [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 572
Study Start Date: March 2004
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
30, 50 or 90 micrograms sc (starting dose) every 2 weeks
Experimental: 2 Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
30, 50 or 90 micrograms sc (starting dose) every 4 weeks
Active Comparator: 3 Drug: epoetin alfa or beta
iv 3 times weekly, as prescribed

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients >=18 years of age;
  • chronic renal anemia;
  • on dialysis therapy for at least 12 weeks before screening;
  • receiving sc epoetin for at least 8 weeks before screening.

Exclusion Criteria:

  • women who are pregnant, breastfeeding or using unreliable birth control methods;
  • administration of another investigational drug within 4 weeks before screening, or during the study period.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00077623

  Hide Study Locations
Locations
United States, Arkansas
Hot Springs, Arkansas, United States, 71901
United States, California
Los Angeles, California, United States, 90033
Riverside, California, United States, 92501
Sacramento, California, United States, 95816-5119
San Jose, California, United States, 95116-1906
United States, Massachusetts
Boston, Massachusetts, United States, 02130
Springfield, Massachusetts, United States, 01107
United States, Michigan
Detroit, Michigan, United States, 48202-2689
United States, Minnesota
Brooklyn Center, Minnesota, United States, 55430
United States, North Carolina
Raleigh, North Carolina, United States, 27609
Winston-salem, North Carolina, United States, 27157-1023
United States, Ohio
Toledo, Ohio, United States, 43606
United States, Oregon
Portland, Oregon, United States, 97210
United States, Texas
Dallas, Texas, United States, 75216
Houston, Texas, United States, 77030
San Antonio, Texas, United States, 78229
United States, West Virginia
Morgantown, West Virginia, United States, 26506
Belgium
Bruxelles, Belgium, 1090
Edegem, Belgium, 2650
Gent, Belgium, 9000
Hasselt, Belgium, 3500
Brazil
Curitiba, Brazil, 81050-090
Sao Paulo, Brazil, 04039-000
Sao Paulo, Brazil, 03065-000
Czech Republic
Brno, Czech Republic, 656 91
Ostrava, Czech Republic, 708 52
Plzen, Czech Republic, 304 60
Denmark
Odense, Denmark, 5000
Finland
HUS, Finland, 00029
Tampere, Finland, 33521
Turku, Finland, 20521
France
Bayonne, France, 64115
Boulogne, France, 62321
Cabestany, France, 66330
Caen, France, 14033
Limoges, France, 87042
Nimes, France, 30029
Pantin, France, 93500
Poitiers, France, 86021
Saint-germain-en-laye, France, 78100
St Priest En Jarez, France, 42055
Thionville, France, 57126
Tours, France, 37044
Germany
Bad Hersfeld, Germany, 36251
Berlin, Germany, 12045
Kaiserslautern, Germany, 67655
Hungary
Budapest, Hungary, 1134
Budapest, Hungary, 1076
Debrecen, Hungary, 4032
Miskolc, Hungary, 3526
Pecs, Hungary, 7624
Italy
Cremona, Italy, 26100
Lecco, Italy, 23900
Mestre, Italy, 30174
Modena, Italy, 41100
Prato, Italy, 50047
Venezia, Italy, 30122
Mexico
Cuernavaca, Mexico, 62448
Mexico City, Mexico, 14000
New Zealand
Christchurch, New Zealand
Wellington, New Zealand
Panama
Panama City, Panama, 0
Poland
Gdansk, Poland, 80-211
Kielce, Poland, 25-736
Krakow, Poland, 31-501
Wroclaw, Poland, 50-417
Puerto Rico
Ponce, Puerto Rico, 00732
South Africa
Durban, South Africa
Spain
Alcorcon, Spain, 28922
Barcelona, Spain, 08035
Madrid, Spain, 28046
Madrid, Spain, 28006
Palma de Mallorca, Spain, 07198
Pamplona, Spain, 31008
Santiago de Compostela, Spain, 15706
Sweden
Huddinge, Sweden, 14186
Karlstad, Sweden, 65185
Taiwan
Taichung, Taiwan, 407
Taipei, Taiwan, 100
Thailand
Bangkok, Thailand, 10400
Bangkok, Thailand, 10310
Phitsanulok, Thailand, 65000
United Kingdom
Belfast, United Kingdom, BT9 7LJ
Cambridge, United Kingdom, CB2 2QQ
Dundee, United Kingdom, DD1 9SY
Exeter, United Kingdom, EX2 5DW
Leicester, United Kingdom, LE5 4PW
London, United Kingdom, SE22 8PT
London, United Kingdom, SW17 0RE
London, United Kingdom, SE1 9RT
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00077623     History of Changes
Other Study ID Numbers: BA16740
Study First Received: February 10, 2004
Last Updated: May 23, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Anemia
Renal Insufficiency, Chronic
Hematologic Diseases
Renal Insufficiency
Kidney Diseases
Urologic Diseases
 Epoetin Alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013