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A Study of Intravenous or Subcutaneous Methoxy Polyethylene Glycol-Epoetin Beta (RO0503821, Mircera) in Chronic Kidney Disease Patients With Renal Anemia

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Anemia

Intervention: Methoxy Polyethylene Glycol-Epoetin Beta (Drug); Epoetin alfa (Drug); Epoetin beta (Drug); Darbepoetin alfa (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche

Summary

This study assessed the long-term efficacy, safety, and tolerability of intravenous (iv) or subcutaneous (sc) methoxy polyethylene glycol-epoetin beta in chronic kidney disease patients with renal anemia. Eligible patients were those who were receiving stable maintenance therapy with methoxy polyethylene glycol-epoetin beta or erythropoiesis stimulating agents (ESAs) in Phase II or III clinical studies. They continued to receive methoxy polyethylene glycol-epoetin beta or comparator ESAs at the same weekly dose and by the same route of administration (sc or iv) as in the qualifying studies.

Clinical Details

Official title: An Open-label, Multi-center Study to Document the Efficacy, Safety, and Tolerability of Long-term Administration of RO0503821 in Patients With Chronic Renal Anemia

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change From Baseline in Hemoglobin Concentration to the Last Month of Study Participation

Secondary outcome: Percentage of Patients Who Had at Least 1 Adverse Event

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Written informed consent

- Adult patients (≥ 18 years old) with chronic renal anemia

- Maintenance erythropoietic therapy with methoxy polyethylene glycol-epoetin beta or a

protocol-specified reference medication (epoetin alfa formulated with human albumin, epoetin beta or darbepoetin alfa) in one of the following studies: BA16528[NCT00048048], BA16285[NCT00048035], BA16286[NCT00364832], BA16736[NCT00077597], BA16738[NCT00081471], BA16739[NCT00077610], BA16740[NCT00077623], BA17283[NCT00077766] and BA17284[NCT00081484]

- Hemoglobin (Hb) concentration between 10. 5 and 13. 0 g/dL

- Adequate iron status defined as serum ferritin ≥ 100 ng/mL or Transferrin Saturation

(TSAT)≥ 20% or percentage of hypochromic red blood cells (RBCs) < 10% Exclusion Criteria:

- Poorly controlled hypertension

- History of epileptic seizure

- Pure red cell aplasia

- Chronic congestive heart failure [New York Heart Association (NYHA) IV]

- High likelihood of early withdrawal or interruption of the study

- Active malignant disease (except non-melanoma skin cancer)

- Life expectancy less than 12 months

- Pregnancy or breast-feeding

Locations and Contacts

Clayton 3186, Australia

Gosford 2250, Australia

Liverpool 1871, Australia

Parkville 3050, Australia

Perth 6847, Australia

Sydney NSW 2148, Australia

Woolloongabba 4102, Australia

Graz 8036, Austria

Aalst 9300, Belgium

Bruxelles 1200, Belgium

Edegem 2650, Belgium

Gent 9000, Belgium

Hasselt 3500, Belgium

Leuven 3000, Belgium

Liege 4000, Belgium

Liberec 460 63, Czech Republic

Ostrava 708 52, Czech Republic

Plzen 304 60, Czech Republic

Aalborg 9100, Denmark

Odense 5000, Denmark

Roskilde 4000, Denmark

HUS 00029, Finland

Tampere 33521, Finland

Bayonne 64115, France

Bois Guillaume 76233, France

Bordeaux 33076, France

Boulogne 62321, France

Cabestany 66330, France

Caen 14033, France

Chambery 73001, France

Colmar 68024, France

Hyeres 83400, France

La Tronche 38700, France

Limoges 87042, France

Lyon 69437, France

Montpellier 34295, France

Nantes 44093, France

Nimes 30029, France

Paris 75908, France

Perpignan 66046, France

Poitiers 86021, France

Saint Ouen 93400, France

Saint-germain-en-laye 78100, France

Salouël 80480, France

Tarbes 65013, France

Thionville 57126, France

Toulouse 31059, France

Tours 37044, France

Bad Hersfeld 36251, Germany

Berlin 12045, Germany

Dortmund 44263, Germany

Erlangen 91054, Germany

München 80804, Germany

Nürnberg 90431, Germany

Stuttgart 70191, Germany

Villingen-schwenningen 78054, Germany

Wiesbaden 65191, Germany

Wiesloch 69168, Germany

Wuppertal 42103, Germany

Alexandroupolis 68100, Greece

Ioannina 45500, Greece

Larissa 41110, Greece

Piraeus 18536, Greece

Thessaloniki 54629, Greece

Budapest 1076, Hungary

Budapest 1134, Hungary

Debrecen 4032, Hungary

Miskolc 3526, Hungary

Pecs 7624, Hungary

Bergamo 24128, Italy

Cagliari 91034, Italy

Cremona 26100, Italy

Cuneo 12100, Italy

Genova 16132, Italy

Lecco 23900, Italy

Livorno 57100, Italy

Lodi 26900, Italy

Messina 98158, Italy

Mestre 30174, Italy

Modena 41100, Italy

Pavia 27100, Italy

Prato 50047, Italy

Reggio Calabria 89100, Italy

S Fermo Della Battaglia 22020, Italy

Venezia 30122, Italy

Cuernavaca 62448, Mexico

Mexico City 14000, Mexico

Heerlen 6419 PC, Netherlands

Trondheim 7006, Norway

Panama City, Panama

Gdansk 80-211, Poland

Gdynia 81-519, Poland

Kielce 25-736, Poland

Krakow 31-501, Poland

Lodz 90-153, Poland

Poznan 60-355, Poland

Rzeszow 35-055, Poland

Szczecin 70-111, Poland

Warszawa 02-006, Poland

Wolomin 05-200, Poland

Wroclaw 50-417, Poland

Setubal 2910-446, Portugal

Ponce 00732, Puerto Rico

Moscow 129110, Russian Federation

Moscow 125101, Russian Federation

Moscow 123182, Russian Federation

St Petersburg 195067, Russian Federation

St Petersburg 197089, Russian Federation

Cape Town 7925, South Africa

Durban, South Africa

Soweto, South Africa

Alcorcon 28922, Spain

Alicante 03010, Spain

Almería 04009, Spain

Badalona 08915, Spain

Barcelona 08003, Spain

Barcelona 08035, Spain

Barcelona 08036, Spain

Bilbao 48013, Spain

Córdoba 14004, Spain

Hospitalet de Llobregat 08907, Spain

La Coruna 15006, Spain

Lerida 25198, Spain

Madrid 28805, Spain

Madrid 28007, Spain

Madrid 28041, Spain

Madrid 28046, Spain

Madrid 28222, Spain

Madrid 28006, Spain

Malaga 29010, Spain

Oviedo 33006, Spain

Palma de Mallorca 07014, Spain

Palma de Mallorca 07198, Spain

Salamanca 37008, Spain

Santander 39008, Spain

Santiago de Compostela 15706, Spain

Sevilla 41013, Spain

Huddinge 14186, Sweden

Karlstad 65185, Sweden

Stockholm 18288, Sweden

Umea 90185, Sweden

Aarau 5001, Switzerland

Lausanne 1011, Switzerland

Lausanne 1003, Switzerland

Taichung 407, Taiwan

Taipei 100, Taiwan

Bangkok 10330, Thailand

Bangkok, Thailand

Bangkok 10700, Thailand

Bangkok 10400, Thailand

Chiang Mai 50200, Thailand

Chonburi, Thailand

Phitsanulok 65000, Thailand

Belfast BT9 7LJ, United Kingdom

Cambridge CB2 2QQ, United Kingdom

Carshalton SM5 1AA, United Kingdom

Dundee DD1 9SY, United Kingdom

Exeter EX2 5DW, United Kingdom

Glasgow G4 OSF, United Kingdom

Leicester LE5 4PW, United Kingdom

London E1 1BB, United Kingdom

London SE1 9RT, United Kingdom

London SE22 8PT, United Kingdom

London SW17 0RE, United Kingdom

Salford M6 8HD, United Kingdom

Swansea SA6 6NL, United Kingdom

Birmingham, Alabama 35211, United States

Mobile, Alabama 36608, United States

Montgomery, Alabama 36106, United States

Hot Springs, Arkansas 71901, United States

Covina, California 91723, United States

Encino, California 91356, United States

Irvine, California 92868, United States

Los Alamitos, California 90720, United States

Los Angeles, California 90073, United States

Los Angeles, California 90095, United States

Monterey Park, California 91754, United States

Mountain View, California 94040, United States

Sacramento, California 95816-5119, United States

San Diego, California 92120, United States

San Diego, California 92123, United States

San Francisco, California 94117, United States

Stanford, California 94305, United States

Colorado Springs, Colorado 80909, United States

Denver, Colorado 80262, United States

Lakewood, Colorado 80260, United States

Stamford, Connecticut 06902, United States

Ocala, Florida 34471, United States

Pembroke Pines, Florida 33028, United States

Atlanta, Georgia 30342, United States

Augusta, Georgia 30309, United States

Honolulu, Hawaii 96813, United States

Maywood, Illinois 60153, United States

South Holland, Illinois 60473, United States

Louisville, Kentucky 40202-1718, United States

Baton Rouge, Louisiana 70884, United States

Shreveport, Louisiana 71101, United States

Boston, Massachusetts 02115, United States

Boston, Massachusetts 02135, United States

Springfield, Massachusetts 01107, United States

Detroit, Michigan 48202-2689, United States

Detroit, Michigan 48236, United States

Kalamazoo, Michigan 49007, United States

Brooklyn Center, Minnesota 55430, United States

Columbus, Mississippi 39705, United States

Tupelo, Mississippi 38801, United States

St Louis, Missouri 63110, United States

Hackensack, New Jersey 07601, United States

Paterson, New Jersey 07503, United States

Albuquerque, New Mexico 87131, United States

Bronx, New York 10467, United States

Brooklyn, New York 11203, United States

Flushing, New York 11355, United States

Great Neck, New York 11021, United States

Mineola, New York 11501, United States

New York, New York 10021, United States

New York, New York 10128, United States

Orchard Park, New York 14127, United States

Chapel Hill, North Carolina 27599-7155, United States

Mount Airy, North Carolina 27030, United States

Raleigh, North Carolina 27609, United States

Cincinnati, Ohio 45267-0585, United States

Cleveland, Ohio 44109, United States

Toledo, Ohio 43606, United States

Oregon City, Oregon 97045, United States

Portland, Oregon 97201-2940, United States

Portland, Oregon 97210, United States

Allentown, Pennsylvania 18103, United States

Erie, Pennsylvania 16502, United States

Lewistown, Pennsylvania 17044, United States

Philadelphia, Pennsylvania 19140, United States

Philadelphia, Pennsylvania 19106, United States

Philadelphia, Pennsylvania 19141, United States

Pittsburgh, Pennsylvania 15224, United States

Columbia, South Carolina 29209, United States

Orangeburg, South Carolina 29118, United States

Chattanooga, Tennessee 37404, United States

Nashville, Tennessee 37205, United States

Nashville, Tennessee 37232, United States

Austin, Texas 78758, United States

Dallas, Texas 75216, United States

Houston, Texas 77030, United States

Houston, Texas 77054, United States

Houston, Texas 77099, United States

Burlington, Vermont 05401, United States

Fairfax, Virginia 22031, United States

Norfolk, Virginia 23507-1901, United States

Salem, Virginia 24153, United States

Morgantown, West Virginia 26506, United States

Additional Information

Starting date: October 2004
Last updated: February 10, 2012

Page last updated: August 20, 2015

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