A Study of 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:	NCT00077623

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 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 Subcutaneous Mircera on Hemoglobin Levels in 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:	572
Study Completion Date:	March 2006

Arms	Assigned Interventions
1: Experimental	Drug: methoxy polyethylene glycol-epoetin beta [Mircera] 30, 50 or 90 micrograms sc (starting dose) every 2 weeks
2: Experimental	Drug: methoxy polyethylene glycol-epoetin beta [Mircera] 30, 50 or 90 micrograms sc (starting dose) every 4 weeks
3: Active Comparator	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

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Locations

United States, Arkansas

HOT SPRINGS, Arkansas, United States, 71901
United States, California

LOS ANGELES, California, United States, 90033

SACRAMENTO, California, United States, 95816-5119

SAN JOSE, California, United States, 95116-1906

RIVERSIDE, California, United States, 92501
United States, Massachusetts

SPRINGFIELD, Massachusetts, United States, 01107

BOSTON, Massachusetts, United States, 02130
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

SAN ANTONIO, Texas, United States, 78229

HOUSTON, Texas, United States, 77030

DALLAS, Texas, United States, 75216
United States, West Virginia

MORGANTOWN, West Virginia, United States, 26506
Belgium

BRUXELLES, Belgium, 1090

GENT, Belgium, 9000

HASSELT, Belgium, 3500

EDEGEM, Belgium, 2650
Brazil

SAO PAULO, Brazil, 03065-000

CURITIBA, Brazil, 81050-090

SAO PAULO, Brazil, 04039-000
Czech Republic

OSTRAVA, Czech Republic, 708 52

BRNO, Czech Republic, 656 91

PLZEN, Czech Republic, 304 60
Denmark

ODENSE, Denmark, 5000
Finland

HUS, Finland, 00029

TURKU, Finland, 20521

TAMPERE, Finland, 33521
France

NIMES, France, 30029

CAEN, France, 14033

ST PRIEST EN JAREZ, France, 42055

LIMOGES, France, 87042

THIONVILLE, France, 57126

SAINT-GERMAIN-EN-LAYE, France, 78100

BOULOGNE, France, 62321

CABESTANY, France, 66330

POITIERS, France, 86021

BAYONNE, France, 64115

TOURS, France, 37044

PANTIN, France, 93500
Germany

BERLIN, Germany, 12045

KAISERSLAUTERN, Germany, 67655

BAD HERSFELD, Germany, 36251
Hungary

DEBRECEN, Hungary, 4032

PECS, Hungary, 7624

MISKOLC, Hungary, 3526

BUDAPEST, Hungary, 1076

BUDAPEST, Hungary, 1134
Italy

MODENA, Italy, 41100

VENEZIA, Italy, 30122

CREMONA, Italy, 26100

MESTRE, Italy, 30174

LECCO, Italy, 23900

PRATO, Italy, 50047
Mexico

MEXICO CITY, Mexico, 14000

CUERNAVACA, Mexico, 62448
New Zealand

CHRISTCHURCH, New Zealand

WELLINGTON, New Zealand
Panama

PANAMA CITY, Panama
Poland

KIELCE, Poland, 25-736

KRAKOW, Poland, 31-501

WROCLAW, Poland, 50-417

GDANSK, Poland, 80-211
Puerto Rico

PONCE, Puerto Rico, 00732
South Africa

DURBAN, South Africa
Spain

BARCELONA, Spain, 08035

MADRID, Spain, 28046

SANTIAGO DE COMPOSTELA, Spain, 15706

MADRID, Spain, 28006

ALCORCON, Spain, 28922

PAMPLONA, Spain, 31008

PALMA DE MALLORCA, Spain, 07198
Sweden

KARLSTAD, Sweden, 65185

HUDDINGE, Sweden, 14186
Taiwan

TAIPEI, Taiwan, 100

TAICHUNG, Taiwan, 407
Thailand

PHITSANULOK, Thailand, 65000

BANGKOK, Thailand, 10400

BANGKOK, Thailand, 10330
United Kingdom

BELFAST, United Kingdom, BT9 7LJ

LONDON, United Kingdom, SE22 8PT

LEICESTER, United Kingdom, LE5 4PW

DUNDEE, United Kingdom, DD1 9SY

LONDON, United Kingdom, SE1 9RT

CAMBRIDGE, United Kingdom, CB2 2QQ

EXETER, United Kingdom, EX2 5DW

LONDON, United Kingdom, SW17 0RE

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:	BA16740
Study First Received:	February 10, 2004
Last Updated:	May 13, 2009
ClinicalTrials.gov Identifier:	NCT00077623 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 25, 2009