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:	NCT00077610

Purpose

This study will assess the efficacy and safety of intravenous Mircera, given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv 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: 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 Intravenous Mircera on Hemoglobin Level/Correction in 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 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:	673
Study Completion Date:	April 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: Experimental	Drug: methoxy polyethylene-glycol epoetin beta [Mircera] 30, 50 or 90 micrograms iv (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 IV 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: NCT00077610

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Locations

United States, Alabama

BIRMINGHAM, Alabama, United States, 35211

MONTGOMERY, Alabama, United States, 36106

MOBILE, Alabama, United States, 36608
United States, California

LOS ANGELES, California, United States, 90095

SAN DIEGO, California, United States, 92103-8342

SAN JOSE, California, United States, 95116-1906

RIVERSIDE, California, United States, 92501

SAN DIEGO, California, United States, 92120

MONTEREY PARK, California, United States, 91754

SACRAMENTO, California, United States, 95816-5119

IRVINE, California, United States, 92868

SAN FRANCISCO, California, United States, 94117

ENCINO, California, United States, 91356
United States, Colorado

COLORADO SPRINGS, Colorado, United States, 80909

DENVER, Colorado, United States, 80262

LAKEWOOD, Colorado, United States, 80260
United States, Florida

OCALA, Florida, United States, 34471

PEMBROKE PINES, Florida, United States, 33028
United States, Georgia

ATLANTA, Georgia, United States, 30342

AUGUSTA, Georgia, United States, 30309
United States, Illinois

MAYWOOD, Illinois, United States, 60153

CHICAGO, Illinois, United States, 60612
United States, Kentucky

LOUISVILLE, Kentucky, United States, 40202-1718
United States, Louisiana

COVINGTON, Louisiana, United States, 70433
United States, Massachusetts

BOSTON, Massachusetts, United States, 02215

SPRINGFIELD, Massachusetts, United States, 01107

BOSTON, Massachusetts, United States, 02115
United States, Michigan

DETROIT, Michigan, United States, 48202-2689
United States, Minnesota

BROOKLYN CENTER, Minnesota, United States, 55430
United States, New Jersey

PATERSON, New Jersey, United States, 07503
United States, New Mexico

ALBUQUERQUE, New Mexico, United States, 87131
United States, New York

MINEOLA, New York, United States, 11501

BRONX, New York, United States, 10467

BROOKLYN, New York, United States, 11203

GREAT NECK, New York, United States, 11021

STONY BROOK, New York, United States, 11794-8161

NEW YORK, New York, United States, 10128

NEW YORK, New York, United States, 10128

NEW YORK, New York, United States, 10021
United States, North Carolina

RALEIGH, North Carolina, United States, 27609

CHAPEL HILL, North Carolina, United States, 27599-7155

WINSTON-SALEM, North Carolina, United States, 27157-1023
United States, Ohio

CINCINNATI, Ohio, United States, 45267-0585

TOLEDO, Ohio, United States, 43606
United States, Oregon

PORTLAND, Oregon, United States, 97210
United States, Pennsylvania

PITTSBURGH, Pennsylvania, United States, 15261

PITTSBURGH, Pennsylvania, United States, 15224

ERIE, Pennsylvania, United States, 16502

PHILADELPHIA, Pennsylvania, United States, 19104
United States, South Carolina

ORANGEBURG, South Carolina, United States, 29118
United States, Tennessee

NASHVILLE, Tennessee, United States, 37232

NASHVILLE, Tennessee, United States, 37205

CHATTANOOGA, Tennessee, United States, 37404
United States, Texas

HOUSTON, Texas, United States, 77099

SAN ANTONIO, Texas, United States, 78229

AUSTIN, Texas, United States, 78705

HOUSTON, Texas, United States, 77054
United States, Vermont

BURLINGTON, Vermont, United States, 05401
United States, Virginia

RICHMOND, Virginia, United States, 23298

FAIRFAX, Virginia, United States, 22031
United States, Wisconsin

MARSHFIELD, Wisconsin, United States, 54449
Canada, Newfoundland and Labrador

ST JOHN'S, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Ontario

TORONTO, Ontario, Canada, M5G 2C4

MISSISSAUGA, Ontario, Canada, L5M 2V8

Toronto, Ontario, Canada, M9N 1N8

SCARBOROUGH, Ontario, Canada, M1H 3G4

KINGSTON, Ontario, Canada, K7L 3N6

LONDON, Ontario, Canada, N6A 5A5
Canada, Quebec

MONTREAL, Quebec, Canada, H3A 1A1
Canada, Saskatchewan

SASKATOON, Saskatchewan, Canada, S7K 1N4
France

BORDEAUX, France, 33076

PARIS, France, 75651

PARIS, France, 75015

TOULOUSE, France, 31054

LA TRONCHE, France, 38700

PARIS, France, 75 016

AUBERVILLIERS, France, 93307
Germany

WIESLOCH, Germany, 69168

STUTTGART, Germany, 70191

MÜNCHEN, Germany, 80804

WUPPERTAL, Germany, 42103

WIESBADEN, Germany, 65191

DORTMUND, Germany, 44263

NÜRNBERG, Germany, 90431
Italy

LODI, Italy, 26900

PAVIA, Italy, 27100

LECCO, Italy, 23900

MILANO, Italy, 20162

COMO, Italy, 22100
Norway

BERGEN, Norway, 5021

LILLEHAMMER, Norway, 2629

LEVANGER, Norway, 7600

TRONDHEIM, Norway, 7006
Spain

LA CORUNA, Spain, 15006

MALAGA, Spain, 29010

SEVILLA, Spain, 41013

BARCELONA, Spain, 08003

MADRID, Spain, 28007
Switzerland

LAUSANNE, Switzerland, 1003

LAUSANNE, Switzerland, 1011

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):

Levin NW, Fishbane S, Canedo FV, Zeig S, Nassar GM, Moran JE, Villa G, Beyer U, Oguey D; MAXIMA study investigators. Intravenous methoxy polyethylene glycol-epoetin beta for haemoglobin control in patients with chronic kidney disease who are on dialysis: a randomised non-inferiority trial (MAXIMA). Lancet. 2007 Oct 20;370(9596):1415-21.

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	BA16739
Study First Received:	February 10, 2004
Last Updated:	May 13, 2009
ClinicalTrials.gov Identifier:	NCT00077610 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 22, 2009