A Study of 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:	NCT00077597

Purpose

This study will assess the efficacy and safety of Mircera given intravenously in the treatment of renal anemia in chronic kidney disease patients on dialysis who are not currently receiving epoetin or any other erythropoietic substance. 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	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 Intravenous Mircera on Hemoglobin Level/Correction 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:

Hemoglobin response rate [ Time Frame: Weeks 1-24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Hb over time, time to target Hb response, incidence of RBC transfusions. Vital signs, ECG, AEs, laboratory values [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment:	182
Study Completion Date:	June 2006

Arms	Assigned Interventions
1: Experimental	Drug: methoxy polyethylene glycol-epoetin beta [Mircera] 0.4 micrograms/kg iv (starting dose) once every 2 weeks
2: Active Comparator	Drug: epoetin 3 times a week iv, 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;
dialysis therapy for at least 2 weeks before screening.

Exclusion Criteria:

women who are pregnant, breastfeeding or using unreliable birth control methods;
administration of any investigational drug within 4 weeks before screening.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00077597

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Locations

United States, California

DAVIS, California, United States, 95616
United States, Colorado

LAKEWOOD, Colorado, United States, 80260
United States, Georgia

AUGUSTA, Georgia, United States, 30309

ATLANTA, Georgia, United States, 30342
United States, Louisiana

NEW ORLEANS, Louisiana, United States, 70112
United States, Massachusetts

BOSTON, Massachusetts, United States, 02115

SPRINGFIELD, Massachusetts, United States, 01107
United States, Michigan

DETROIT, Michigan, United States, 48202-2689
United States, New York

MINEOLA, New York, United States, 11501

NEW YORK, New York, United States, 10128
United States, Ohio

TOLEDO, Ohio, United States, 43606
United States, Texas

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

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

NORFOLK, Virginia, United States, 23507-1901
Brazil

SAO PAULO, Brazil, 01307-001

SAO PAULO, Brazil, 04039-000

CURITIBA, Brazil, 81050-090

RIBEIRÃO PRETO, Brazil, 14025-170
Canada, Alberta

CALGARY, Alberta, Canada, T2N 2T9
Canada, British Columbia

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

WINNIPEG, Manitoba, Canada, R3A 1R9
Canada, Newfoundland and Labrador

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

TORONTO, Ontario, Canada, M5G 2C4

KINGSTON, Ontario, Canada, K7L 3N6

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

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

SASKATOON, Saskatchewan, Canada, S7K 1N4
Czech Republic

USTI NAD LABEM, Czech Republic, 401 13

PRAHA, Czech Republic, 169 00

LIBEREC, Czech Republic, 460 63
Greece

ALEXANDROUPOLIS, Greece, 68100

NIKEA, Greece, 18354

THESSALONIKI, Greece, 54629

LARISSA, Greece, 41110
Norway

BERGEN, Norway, 5021

OSLO, Norway, 0407
Poland

KRAKOW, Poland, 31-501

GDANSK, Poland, 80-211

WROCLAW, Poland, 50-417

WOLOMIN, Poland, 05-200

POZNAN, Poland, 60-355

SZCZECIN, Poland, 70-111

GDYNIA, Poland, 81-519

LODZ, Poland, 90-153
Russian Federation

ST PETERSBURG, Russian Federation, 197089

ST PETERSBURG, Russian Federation, 195067

MOSCOW, Russian Federation, 129110

MOSCOW, Russian Federation, 123182

MOSCOW, Russian Federation, 125101
South Africa

CAPE TOWN, South Africa, 7925

JOHANNESBURG, South Africa, 2193

SOWETO, South Africa
Spain

SANTANDER, Spain, 39008

BILBAO, Spain, 48013
Sweden

KARLSTAD, Sweden, 65185
Switzerland

LAUSANNE, Switzerland, 1011
Thailand

BANGKOK, Thailand

BANGKOK, Thailand, 10700

CHONBURI, Thailand

CHIANG MAI, Thailand, 50200

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):

Klinger M, Arias M, Vargemezis V, Besarab A, Sulowicz W, Gerntholtz T, Ciechanowski K, Dougherty FC, Beyer U. Efficacy of intravenous methoxy polyethylene glycol-epoetin beta administered every 2 weeks compared with epoetin administered 3 times weekly in patients treated by hemodialysis or peritoneal dialysis: a randomized trial. Am J Kidney Dis. 2007 Dec;50(6):989-1000.

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	BA16736
Study First Received:	February 10, 2004
Last Updated:	May 13, 2009
ClinicalTrials.gov Identifier:	NCT00077597 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Hematologic Diseases
Anemia

ClinicalTrials.gov processed this record on November 30, 2009