A Study of Intravenous Mircera for the Treatment of Anemia in Dialysis Patients. - Full Text View

Sponsor:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00077766

Purpose

This study will assess the efficacy and safety of intravenous (iv) Mircera given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv darbepoetin alfa. 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: Darbepoetin alfa	Phase III

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 Maintenance Intravenous Mircera on Hemoglobin Levels in Anemic Dialysis Patients With Chronic Kidney Disease

Resource links provided by NLM:

MedlinePlus related topics: Anemia

Drug Information available for: Epoetin beta Darbepoetin alfa

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 [ 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:	313
Study Completion Date:	February 2006

Arms	Assigned Interventions
1: Experimental	Drug: methoxy polyethylene glycol-epoetin beta [Mircera] 30, 50 or 90 micrograms iv (starting dose) every 2 weeks
2: Active Comparator	Drug: Darbepoetin alfa iv weekly, every 2 weeks, 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 darbepoetin alfa iv 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: NCT00077766

Hide Study Locations

Locations

Australia

GOSFORD, Australia, 2250

WOOLLOONGABBA, Australia, 4102

MELBOURNE, Australia, 3168

SYDNEY, Australia, NSW 2148

PARKVILLE, Australia, 3052

LIVERPOOL, Australia, 1871
Austria

GRAZ, Austria, 8036
Belgium

BRUXELLES, Belgium, 1200

AALST, Belgium, 9300

LIEGE, Belgium, 4000

BRUXELLES, Belgium, 1070
Canada, Alberta

CALGARY, Alberta, Canada, T2N 2T9

EDMONTON, Alberta, Canada, T6G 2B7
Canada, British Columbia

KAMLOOPS, British Columbia, Canada, V2C 2T1

VANCOUVER, British Columbia, Canada, V5Z 1M9
Canada, Manitoba

WINNIPEG, Manitoba, Canada, R2H 2A6

WINNIPEG, Manitoba, Canada, R3A 1R9
Canada, Nova Scotia

HALIFAX, Nova Scotia, Canada, B3H 1V8
Canada, Ontario

MISSISSAUGA, Ontario, Canada, L5M 2V8

KITCHENER, Ontario, Canada, N2G 1N9
Denmark

ODENSE, Denmark, 5000

ROSKILDE, Denmark, 4000

AALBORG, Denmark, 9100

KØBENHAVN, Denmark, 2100
Finland

HUS, Finland, 00029

PORI, Finland, 28500
France

MONTPELLIER, France, 34090

STRASBOURG, France, 67091

TOULOUSE, France, 31077

AUBERVILLIERS, France, 93307

NICE, France, 06002

TARBES, France, 65013
Germany

NÜRNBERG, Germany, 90431

VILLINGEN-SCHWENNINGEN, Germany, 78054

HANN. MÜNDEN, Germany, 34346
Italy

PAVIA, Italy, 27100

BERGAMO, Italy, 24128

LECCO, Italy, 23900

LIVORNO, Italy, 57100

MESSINA, Italy, 98158
Spain

BARCELONA, Spain, 08036

SANTANDER, Spain, 39008

CÓRDOBA, Spain, 14004

MADRID, Spain, 28035

SALAMANCA, Spain, 37008

OVIEDO, Spain, 33006

BADALONA, Spain, 08915
Sweden

KARLSTAD, Sweden, 65185

STOCKHOLM, Sweden, 18288

UPPSALA, Sweden, 751 85
Switzerland

LAUSANNE, Switzerland, 1003

AARAU, Switzerland, 5001

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Canaud B, Mingardi G, Braun J, Aljama P, Kerr PG, Locatelli F, Villa G, Van Vlem B, McMahon AW, Kerloëguen C, Beyer U; STRIATA Study Investigators. Intravenous C.E.R.A. maintains stable haemoglobin levels in patients on dialysis previously treated with darbepoetin alfa: results from STRIATA, a randomized phase III study. Nephrol Dial Transplant. 2008 Nov;23(11):3654-61. Epub 2008 Jun 27.

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	BA17283
Study First Received:	February 12, 2004
Last Updated:	May 13, 2009
ClinicalTrials.gov Identifier:	NCT00077766 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Hematinics
Hematologic Diseases
Therapeutic Uses
Hematologic Agents

Darbepoetin alfa
Anemia
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 25, 2009