A Study of Intravenous or Subcutaneous 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:	NCT00081484

Purpose

This study will assess the efficacy and safety of intravenous (iv) or subcutaneous (sc) Mircera, administered with pre-filled syringes, as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv or sc epoetin. 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 or beta	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 Mircera Administered With Pre-Filled Syringes on Hemoglobin Levels in Anemic Dialysis Patients With Chronic Kidney Disease

Resource links provided by NLM:

MedlinePlus related topics: Anemia

Drug Information available for: Erythropoietin Epoetin alfa Epoetin beta

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:	336
Study Completion Date:	March 2006

Arms	Assigned Interventions
1: Experimental	Drug: methoxy polyethylene glycol-epoetin beta [Mircera] 30, 50 or 90 micrograms iv or sc (starting dose) every 2 weeks
2: Active Comparator	Drug: epoetin alfa or beta iv or sc, 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 iv or 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: NCT00081484

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Locations

United States, California

COVINA, California, United States, 91723

SAN DIEGO, California, United States, 92123

SAN DIEGO, California, United States, 92161

LOS ANGELES, California, United States, 90073

LOS ALAMITOS, California, United States, 90720
United States, Florida

TAMPA, Florida, United States, 33617
United States, Hawaii

HONOLULU, Hawaii, United States, 96813
United States, Illinois

SOUTH HOLLAND, Illinois, United States, 60473
United States, Louisiana

SHREVEPORT, Louisiana, United States, 71103

SHREVEPORT, Louisiana, United States, 71101

BATON ROUGE, Louisiana, United States, 70884
United States, Massachusetts

BOSTON, Massachusetts, United States, 02135
United States, Michigan

KALAMAZOO, Michigan, United States, 49007
United States, Mississippi

COLUMBUS, Mississippi, United States, 39705

TUPELO, Mississippi, United States, 38801
United States, Missouri

ST LOUIS, Missouri, United States, 63110
United States, New Jersey

HACKENSACK, New Jersey, United States, 07601
United States, New York

FLUSHING, New York, United States, 11355

ORCHARD PARK, New York, United States, 14127

NEW YORK, New York, United States, 10025
United States, Ohio

CLEVELAND, Ohio, United States, 44195

CLEVELAND, Ohio, United States, 44109
United States, Oregon

OREGON CITY, Oregon, United States, 97045
United States, Pennsylvania

ERIE, Pennsylvania, United States, 16502

LEWISTOWN, Pennsylvania, United States, 17044

PHILADELPHIA, Pennsylvania, United States, 19106

PHILADELPHIA, Pennsylvania, United States, 19140

PHILADELPHIA, Pennsylvania, United States, 19141
United States, South Carolina

COLUMBIA, South Carolina, United States, 29209
United States, Virginia

CHARLOTTESVILLE, Virginia, United States, 22908

NORFOLK, Virginia, United States, 23507-1901
Canada, Ontario

TORONTO, Ontario, Canada, M5G 2C4

OTTAWA, Ontario, Canada, K1H 7W9
Canada, Quebec

MONTREAL, Quebec, Canada, H3G 1A4

GREENFIELD PARK, Quebec, Canada, J4V 2H1
France

CHAMBERY, France, 73001

NANTES, France, 44093

LE KREMLIN-BICETRE, France, 94275

ROUEN, France, 76031

AIX EN PROVENCE, France, 13616

HYERES, France, 83400

PARIS, France, 75970
Germany

MÜNCHEN, Germany, 80804

NÜRNBERG, Germany, 90431

ERLANGEN, Germany, 91054
Italy

MODENA, Italy, 41100

PAVIA, Italy, 27100

COMO, Italy, 22100
Poland

RZESZOW, Poland, 35-055

WARSZAWA, Poland, 02-006
Portugal

CARNAXIDE, Portugal, 2799-523

PORTO, Portugal, 4099-001

SETUBAL, Portugal, 2910-446
Puerto Rico

SAN JUAN, Puerto Rico, 00936-5067

PONCE, Puerto Rico, 00732
Spain

ALICANTE, Spain, 03010

MADRID, Spain, 28007
Taiwan

KAOHSIUNG, Taiwan, 833

TAICHUNG, Taiwan, 407

TAIPEI, Taiwan, 100
Thailand

BANGKOK, Thailand
United Kingdom

GLASGOW, United Kingdom, G4 OSF

LONDON, United Kingdom, E1 1BB

SALFORD, United Kingdom, M6 8HD

HERTFORD, United Kingdom, SG1 4AB

SWANSEA, United Kingdom, SA6 6NL

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	BA17284
Study First Received:	April 13, 2004
Last Updated:	May 13, 2009
ClinicalTrials.gov Identifier:	NCT00081484 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Epoetin Alfa
Hematinics
Hematologic Diseases
Therapeutic Uses

Hematologic Agents
Anemia
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 27, 2009