The purpose of this study is to document that RO0503821 administered for prolonged periods (104 weeks) is efficacious, safe, and well tolerated in patients treated for chronic renal anemia.

Condition	Treatment or Intervention	Phase
Anemia	Drug: RO0503821	Phase III

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Written informed consent
• Adult patients (greater than or equal to 18 years of age) with chronic renal anemia
• Maintenance erythropoietic therapy with RO0503821 or a protocol-specified reference medication (epoetin alfa formulated with human albumin, epoetin beta or darbepoetin alfa) in one of the following studies: BA16528, BA16285, BA16286, BA16736, BA16738, BA16739, BA16740, BA17283 or BA17284
• Hemoglobin concentration between 10.5 and 13.0 g/dL
• Adequate iron status defined as serum ferritin greater than or equal to 100 ng/mL or TSAT greater than or equal to 20% (or percentage of hypochromic RBCs less than 10%)

Exclusion Criteria:

• Poorly controlled hypertension necessitating interruption of erythropoietic treatment in the 6 months before screening
• Epileptic seizure in the 6 months before screening
• Platelets greater than 500 x 10 9/L
• Pure red cell aplasia (PRCA)
• Chronic congestive heart failure (New York Heart Association Class IV)
• High likelihood of early withdrawal or interruption of the study (e.g., myocardial infarction, severe or unstable coronary artery disease, stroke, severe liver disease within the 12 weeks before screening)
• Active malignant disease (except non-melanoma skin cancer), defined as disease-free for a period of five years
• Life expectancy less than 12 months
• Pregnancy or breast-feeding - Women of childbearing potential without effective contraception
• Administration of another investigational drug planned during the study period
• Known hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study or reference drug formulations

Please reference Study ID Number: PDO-BH18387      973-235-5000 
or      800-526-6367 (FOR US ONLY) 

Alabama
      Birmingham,  Alabama,  35211,  United States; Not yet recruiting
      Montgomery,  Alabama,  36106,  United States; Not yet recruiting
      Mobile,  Alabama,  36608,  United States; Not yet recruiting
Arkansas
      Hot Springs,  Arkansas,  71901,  United States; Not yet recruiting
California
      Stanford,  California,  94305-5114,  United States; Not yet recruiting
      Los Angeles,  California,  90073,  United States; Not yet recruiting
      Los Angeles,  California,  90095,  United States; Recruiting
      Mather,  California,  95655,  United States; Not yet recruiting
      Covina,  California,  91723,  United States; Not yet recruiting
      San Diego,  California,  92161,  United States; Not yet recruiting
      San Diego,  California,  92123,  United States; Not yet recruiting
      San Diego,  California,  92103-8342,  United States; Not yet recruiting
      San Diego,  California,  92120,  United States; Not yet recruiting
      Los Alamitos,  California,  90720,  United States; Not yet recruiting
      San Francisco,  California,  94117,  United States; Not yet recruiting
      San Jose,  California,  95116-1906,  United States; Not yet recruiting
      Monterey Park,  California,  91754,  United States; Not yet recruiting
      Tarzana,  California,  91356,  United States; Not yet recruiting
      Sacramento,  California,  95816-5119,  United States; Not yet recruiting
      Riverside,  California,  92501,  United States; Not yet recruiting
      Irvine,  California,  92868,  United States; Not yet recruiting
Colorado
      Colorado Springs,  Colorado,  80909,  United States; Not yet recruiting
      Lakewood,  Colorado,  80260,  United States; Not yet recruiting
      Denver,  Colorado,  80262,  United States; Not yet recruiting
Connecticut
      Stamford,  Connecticut,  06902,  United States; Not yet recruiting
Florida
      Ocala,  Florida,  34471,  United States; Not yet recruiting
      Tampa,  Florida,  33617,  United States; Not yet recruiting
      Pembroke Pines,  Florida,  33028,  United States; Recruiting
Georgia
      Atlanta,  Georgia,  30342,  United States; Not yet recruiting
      Augusta,  Georgia,  30309,  United States; Not yet recruiting
Hawaii
      Honolulu,  Hawaii,  96813,  United States; Not yet recruiting
Illinois
      South Holland,  Illinois,  60473,  United States; Not yet recruiting
      Maywood,  Illinois,  60153,  United States; Recruiting
      Chicago,  Illinois,  60612,  United States; Not yet recruiting
Kentucky
      Louisville,  Kentucky,  40202-1718,  United States; Not yet recruiting
Louisiana
      Shreveport,  Louisiana,  71101,  United States; Not yet recruiting
      Shreveport,  Louisiana,  71103,  United States; Not yet recruiting
      Baton Rouge,  Louisiana,  70884,  United States; Not yet recruiting
Massachusetts
      Boston,  Massachusetts,  02135,  United States; Not yet recruiting
      Boston,  Massachusetts,  02130,  United States; Not yet recruiting
      Boston,  Massachusetts,  02115,  United States; Not yet recruiting
      Springfield,  Massachusetts,  01107,  United States; Not yet recruiting
Michigan
      Detroit,  Michigan,  48236,  United States; Recruiting
      Detroit,  Michigan,  48202,  United States; Recruiting
      Detroit,  Michigan,  48202,  United States; Terminated
      Kalamazoo,  Michigan,  49007,  United States; Not yet recruiting
Minnesota
      Brooklyn Center,  Minnesota,  55430,  United States; Recruiting
Mississippi
      Columbus,  Mississippi,  39705,  United States; Not yet recruiting
      Tupelo,  Mississippi,  38801,  United States; Not yet recruiting
Missouri
      St. Louis,  Missouri,  63110,  United States; Not yet recruiting
Nevada
      Las Vegas,  Nevada,  89106,  United States; Not yet recruiting
New Jersey
      Hackensack,  New Jersey,  07601,  United States; Not yet recruiting
      Paterson,  New Jersey,  07503,  United States; Not yet recruiting
New Mexico
      Albuquerque,  New Mexico,  87131,  United States; Not yet recruiting
New York
      Flushing,  New York,  11355,  United States; Not yet recruiting
      Orchard Park,  New York,  14127,  United States; Not yet recruiting
      New York,  New York,  10128,  United States; Not yet recruiting
      New York,  New York,  10021,  United States; Not yet recruiting
      Bronx,  New York,  10467,  United States; Not yet recruiting
      Mineola,  New York,  11501,  United States; Not yet recruiting
      Brooklyn,  New York,  11203,  United States; Not yet recruiting
      Great Neck,  New York,  11021,  United States; Not yet recruiting
North Carolina
      Winston Salem,  North Carolina,  27157-1023,  United States; Not yet recruiting
      Raleigh,  North Carolina,  27609,  United States; Not yet recruiting
      Chapel Hill,  North Carolina,  27599-7155,  United States; Not yet recruiting
Ohio
      Cincinnati,  Ohio,  45220,  United States; Not yet recruiting
      Cincinnati,  Ohio,  45267-0585,  United States; Not yet recruiting
      Cleveland,  Ohio,  44195,  United States; Not yet recruiting
      Cleveland,  Ohio,  44109,  United States; Not yet recruiting
      Toledo,  Ohio,  43606,  United States; Not yet recruiting
Oregon
      Portland,  Oregon,  97201-2940,  United States; Not yet recruiting
      Portland,  Oregon,  97210,  United States; Not yet recruiting
      Oregon City,  Oregon,  97045,  United States; Not yet recruiting
Pennsylvania
      Allentown,  Pennsylvania,  18103,  United States; Not yet recruiting
      Philadelphia,  Pennsylvania,  19106,  United States; Not yet recruiting
      Philadelphia,  Pennsylvania,  19140,  United States; Not yet recruiting
      Philadelphia,  Pennsylvania,  19141,  United States; Not yet recruiting
      Philadelphia,  Pennsylvania,  19104,  United States; Not yet recruiting
      Lewistown,  Pennsylvania,  17044,  United States; Not yet recruiting
      Erie,  Pennsylvania,  16502,  United States; Not yet recruiting
      Pittsburgh,  Pennsylvania,  15261,  United States; Not yet recruiting
      Pittsburgh,  Pennsylvania,  15224,  United States; Not yet recruiting
South Carolina
      Columbia,  South Carolina,  29209,  United States; Not yet recruiting
      Orangeburg,  South Carolina,  29118,  United States; Not yet recruiting
Tennessee
      Nashville,  Tennessee,  37232-1371,  United States; Recruiting
      Nashville,  Tennessee,  37205,  United States; Not yet recruiting
      Chattanooga,  Tennessee,  37404,  United States; Not yet recruiting
Texas
      Austin,  Texas,  78705,  United States; Not yet recruiting
      Houston,  Texas,  77054,  United States; Not yet recruiting
      Houston,  Texas,  77074,  United States; Not yet recruiting
      Houston,  Texas,  77030,  United States; Not yet recruiting
      Dallas,  Texas,  75216,  United States; Not yet recruiting
      San Antonio,  Texas,  78229,  United States; Not yet recruiting
Vermont
      Burlington,  Vermont,  05401,  United States; Not yet recruiting
Virginia
      Salem,  Virginia,  24153,  United States; Not yet recruiting
      Charlottesville,  Virginia,  22908,  United States; Not yet recruiting
      Norfolk,  Virginia,  23507-1901,  United States; Not yet recruiting
      Fairfax,  Virginia,  22031,  United States; Not yet recruiting
West Virginia
      Morgantown,  West Virginia,  26506,  United States; Not yet recruiting
Wisconsin
      Marshfield,  Wisconsin,  54449,  United States; Not yet recruiting
Australia
      Perth,  6847,  Australia; Not yet recruiting
      Clayton,  3168,  Australia; Not yet recruiting
      Sydney,  1871,  Australia; Not yet recruiting
      Parkville,  3050,  Australia; Not yet recruiting
      Gosford,  2250,  Australia; Not yet recruiting
      Brisbane,  4102,  Australia; Not yet recruiting
      BLACKTOWN,  NSW 2148,  Australia; Not yet recruiting
Austria
      Graz,  8036,  Austria; Not yet recruiting
Belgium
      Leuven,  3000,  Belgium; Not yet recruiting
      BRUXELLES,  1090,  Belgium; Not yet recruiting
      BRUXELLES,  1070,  Belgium; Not yet recruiting
      BRUXELLES,  1200,  Belgium; Not yet recruiting
      Hasselt,  3500,  Belgium; Not yet recruiting
      Gent,  9000,  Belgium; Not yet recruiting
      LIEGE,  4000,  Belgium; Not yet recruiting
      Aalst,  9300,  Belgium; Not yet recruiting
      Edegem,  2650,  Belgium; Not yet recruiting
Canada, Alberta
      Calgary,  Alberta,  T2N 2T9,  Canada; Not yet recruiting
      Edmonton,  Alberta,  T6G 2B7,  Canada; Not yet recruiting
Canada, British Columbia
      Vancouver,  British Columbia,  V6Z 1Y6,  Canada; Not yet recruiting
      New Westminster,  British Columbia,  V3L 3W7,  Canada; Not yet recruiting
      Kamloops,  British Columbia,  V2C 2T1,  Canada; Not yet recruiting
Canada, Manitoba
      Winnipeg,  Manitoba,  R2H 2A6,  Canada; Not yet recruiting
      Winnipeg,  Manitoba,  R3A 1R9,  Canada; Not yet recruiting
Canada, Newfoundland and Labrador
      St. John's,  Newfoundland and Labrador,  A1B 3V6,  Canada; Not yet recruiting
Canada, Nova Scotia
      Halifax,  Nova Scotia,  B3H 1V8,  Canada; Not yet recruiting
Canada, Ontario
      London,  Ontario,  N6A 5A5,  Canada; Not yet recruiting
      Toronto,  Ontario,  M5G 2C4,  Canada; Not yet recruiting
      Toronto,  Ontario,  M4N 3M5,  Canada; Not yet recruiting
      Kitchener,  Ontario,  N2G 1N9,  Canada; Not yet recruiting
      Scarborough,  Ontario,  M1H 3G4,  Canada; Not yet recruiting
      Ottawa,  Ontario,  K1H 7W9,  Canada; Not yet recruiting
      Mississauga,  Ontario,  L5M 2V8,  Canada; Not yet recruiting
      Kingston,  Ontario,  K7L 3N6,  Canada; Not yet recruiting
      Weston,  Ontario,  M9N 1N8,  Canada; Not yet recruiting
Canada, Quebec
      Montreal,  Quebec,  H1T 2M4,  Canada; Not yet recruiting
      Montreal,  Quebec,  H3A 1A1,  Canada; Not yet recruiting
      Montreal,  Quebec,  H3G 1A4,  Canada; Not yet recruiting
      Greenfield Park,  Quebec,  J4V 2H1,  Canada; Not yet recruiting
Canada, Saskatchewan
      Saskatoon,  Saskatchewan,  S7K 1N4,  Canada; Not yet recruiting
Czech Republic
      LIBEREC,  460 63,  Czech Republic; Not yet recruiting
      Praha,  169 00,  Czech Republic; Not yet recruiting
      PILSEN,  304 60,  Czech Republic; Not yet recruiting
      Brno,  65691,  Czech Republic; Not yet recruiting
      OSTRAVA PORUBA,  708 52,  Czech Republic; Not yet recruiting
Denmark
      Roskilde,  4000,  Denmark; Not yet recruiting
      Aalborg,  9100,  Denmark; Not yet recruiting
      Odense,  5000,  Denmark; Not yet recruiting
Finland
      Tampere,  33521,  Finland; Not yet recruiting
      Turku,  20521,  Finland; Not yet recruiting
      HUS,  00029,  Finland; Not yet recruiting
France
      Vandoeuvre-les-Nancy,  54511,  France; Not yet recruiting
      Perpignan,  66046,  France; Not yet recruiting
      Nantes,  44035,  France; Not yet recruiting
      Nantes,  44093,  France; Not yet recruiting
      Toulouse,  31059,  France; Not yet recruiting
      Paris,  75908,  France; Not yet recruiting
      Lyon,  69437,  France; Not yet recruiting
      Amiens,  80054,  France; Not yet recruiting
      Colmar,  68024,  France; Not yet recruiting
      Chambery,  73001,  France; Not yet recruiting
      Rouen,  76031,  France; Not yet recruiting
      Hyeres,  83400,  France; Not yet recruiting
      Strasbourg,  67091,  France; Not yet recruiting
      Aubervilliers,  93307,  France; Not yet recruiting
      Nice,  06002,  France; Not yet recruiting
      Tarbes,  65013,  France; Not yet recruiting
      Montpellier,  34295,  France; Not yet recruiting
      Poitiers,  86021,  France; Not yet recruiting
      Cabestany,  66330,  France; Not yet recruiting
      Saint-Etienne,  12055,  France; Not yet recruiting
      Limoges,  87042,  France; Not yet recruiting
      Saint-Germain-en-Laye,  78100,  France; Not yet recruiting
      Nimes,  30029,  France; Not yet recruiting
      Caen,  14033,  France; Not yet recruiting
      Boulogne-sur-Mer,  62321,  France; Not yet recruiting
      Tours,  37044,  France; Not yet recruiting
      Bayonne,  64115,  France; Not yet recruiting
      Thionville,  57126,  France; Not yet recruiting
      Bordeaux,  33076,  France; Not yet recruiting
      Grenoble,  38043,  France; Not yet recruiting
Germany
      Duesseldorf,  40225,  Germany; Not yet recruiting
      Dortmund,  44263,  Germany; Not yet recruiting
      Bonn,  53105,  Germany; Not yet recruiting
      Aschaffenburg,  63741,  Germany; Not yet recruiting
      Tuebingen,  72076,  Germany; Not yet recruiting
      Berlin,  13353,  Germany; Not yet recruiting
      Berlin,  12045,  Germany; Not yet recruiting
      Muenchen,  80804,  Germany; Not yet recruiting
      Nuernberg,  90431,  Germany; Not yet recruiting
      Erlangen,  91054,  Germany; Not yet recruiting
      Villingen-Schwenningen,  78054,  Germany; Not yet recruiting
      Wiesbaden,  65191,  Germany; Not yet recruiting
      Stuttgart,  70191,  Germany; Not yet recruiting
      WIESLOCH,  69168,  Germany; Not yet recruiting
      BAD HERSFELD,  36251,  Germany; Not yet recruiting
      Wuppertal,  42103,  Germany; Not yet recruiting
      HANN. MUENDEN,  34346,  Germany; Not yet recruiting
Greece
      IOANNIAN,  45500,  Greece; Not yet recruiting
      THESSALONIKI,  54629,  Greece; Not yet recruiting
      ALEXANDROUPOLIS,  68100,  Greece; Not yet recruiting
      PIREAS,  18536,  Greece; Not yet recruiting
      LARISSA,  41001,  Greece; Not yet recruiting
Hungary
      Pecs,  H-7624,  Hungary; Not yet recruiting
      Debrecen,  4032,  Hungary; Not yet recruiting
      Budapest,  1076,  Hungary; Not yet recruiting
      Budapest,  1134,  Hungary; Not yet recruiting
      Miskolc,  3526,  Hungary; Not yet recruiting
Italy
      Cuneo,  12100,  Italy; Not yet recruiting
      Lecco,  23900,  Italy; Not yet recruiting
      Pavia,  27100,  Italy; Recruiting
      Modena,  41100,  Italy; Recruiting
      Cagliari,  09100,  Italy; Not yet recruiting
      Prato,  50047,  Italy; Not yet recruiting
      Lodi,  26900,  Italy; Not yet recruiting
      Roma,  00184,  Italy; Not yet recruiting
      Genova,  16132,  Italy; Not yet recruiting
      Reggio Calabria,  89100,  Italy; Not yet recruiting
      Como,  22100,  Italy; Not yet recruiting
      Cremona,  26100,  Italy; Not yet recruiting
      Venezia,  30122,  Italy; Not yet recruiting
      VENEZIA MESTRE,  30174,  Italy; Not yet recruiting
      Bergamo,  24128,  Italy; Not yet recruiting
      Messina,  98158,  Italy; Not yet recruiting
      Livorno,  57100,  Italy; Not yet recruiting
Mexico
      Cuernavaca,  62448,  Mexico; Not yet recruiting
      Mexico City,  14000,  Mexico; Not yet recruiting
Netherlands
      HEERLEN,  6401,  Netherlands; Not yet recruiting
      Amersfoort,  3818,  Netherlands; Not yet recruiting
Norway
      BERGEN,  5021,  Norway; Not yet recruiting
      LILLEHAMMER,  2629,  Norway; Not yet recruiting
      Trondheim,  7006,  Norway; Not yet recruiting
Panama
      Panama City,  32405,  Panama; Not yet recruiting
Poland
      Poznan,  60-355,  Poland; Not yet recruiting
      GDYNIA,  81-519,  Poland; Not yet recruiting
      Wroclaw,  50-417,  Poland; Not yet recruiting
      Krakow,  31-501,  Poland; Not yet recruiting
      Lodz,  90153,  Poland; Not yet recruiting
      Szczecin,  70-111,  Poland; Not yet recruiting
      Kielce,  25-736,  Poland; Not yet recruiting
      Gdansk,  80-211,  Poland; Not yet recruiting
      WOLOMIN,  05-200,  Poland; Not yet recruiting
Portugal
      SETUBAL,  2910-446,  Portugal; Not yet recruiting
      Porto,  4099-001,  Portugal; Not yet recruiting
Puerto Rico
      San Juan,  00936-5067,  Puerto Rico; Not yet recruiting
      Ponce,  00732,  Puerto Rico; Not yet recruiting
Russian Federation
      Moscow,  123182,  Russian Federation; Not yet recruiting
      Moscow,  125101,  Russian Federation; Not yet recruiting
      Moscow,  129110,  Russian Federation; Not yet recruiting
      St Petersburg,  195067,  Russian Federation; Not yet recruiting
      St Petersburg,  197089,  Russian Federation; Not yet recruiting
South Africa
      Durban,  South Africa; Not yet recruiting
      Soweto,  South Africa; Not yet recruiting
      Johannesburg,  2193,  South Africa; Not yet recruiting
      CAPETOWN,  7925,  South Africa; Not yet recruiting
Spain
      Madrid,  28046,  Spain; Not yet recruiting
      Madrid,  28805,  Spain; Not yet recruiting
      Madrid,  28041,  Spain; Not yet recruiting
      Madrid,  28007,  Spain; Not yet recruiting
      Madrid,  28006,  Spain; Not yet recruiting
      Madrid,  28035,  Spain; Not yet recruiting
      Lerida,  25198,  Spain; Not yet recruiting
      Almeria,  04009,  Spain; Not yet recruiting
      Barcelona,  08907,  Spain; Not yet recruiting
      Barcelona,  08036,  Spain; Not yet recruiting
      Barcelona,  08003,  Spain; Not yet recruiting
      Barcelona,  08035,  Spain; Not yet recruiting
      Palma de Mallorca,  07014,  Spain; Not yet recruiting
      Palma de Mallorca,  07198,  Spain; Not yet recruiting
      Alicante,  03010,  Spain; Not yet recruiting
      Badalona,  08915,  Spain; Not yet recruiting
      Santander,  39008,  Spain; Not yet recruiting
      Salamanca,  37008,  Spain; Not yet recruiting
      Bilbao,  48013,  Spain; Not yet recruiting
      La Coruna,  15006,  Spain; Not yet recruiting
      Oviedo,  33006,  Spain; Not yet recruiting
      Malaga,  29010,  Spain; Not yet recruiting
      Cordoba,  14004,  Spain; Not yet recruiting
      Sevilla,  41013,  Spain; Not yet recruiting
      ALCORCON (MADRID),  28922,  Spain; Not yet recruiting
      Santiago de Compostela,  15706,  Spain; Not yet recruiting
Switzerland
      Lausanne,  1003,  Switzerland; Not yet recruiting
      Lausanne,  1011,  Switzerland; Not yet recruiting
      AARAU,  5001,  Switzerland; Not yet recruiting
Taiwan, Province of China
      Taipei,  Taiwan, Province of China; Not yet recruiting
      Taichung,  Taiwan, Province of China; Not yet recruiting
      Kaohsiung,  833,  Taiwan, Province of China; Not yet recruiting
Thailand
      Bangkok,  Thailand; Not yet recruiting
      Bangkok,  10400,  Thailand; Not yet recruiting
      Bangkok,  10700,  Thailand; Not yet recruiting
      Bangkok,  10330,  Thailand; Not yet recruiting
      CHONBURI,  Thailand; Not yet recruiting
      PHITSANULOK,  65000,  Thailand; Not yet recruiting
      Chiang Mai,  50200,  Thailand; Not yet recruiting
United Kingdom
      Nottingham,  NG2 3HF,  United Kingdom; Completed
      London,  SE1 9 RT,  United Kingdom; Not yet recruiting
      London,  SE22 8PT,  United Kingdom; Not yet recruiting
      London,  SW17 ORE,  United Kingdom; Not yet recruiting
      London,  E1 1BB,  United Kingdom; Not yet recruiting
      Leicester,  LE5 4PW,  United Kingdom; Not yet recruiting
      CARSHALTON, SURREY,  SM5 1AA,  United Kingdom; Not yet recruiting
      Swansea,  SA6 6NL,  United Kingdom; Not yet recruiting
      Salford,  M6 8HD,  United Kingdom; Not yet recruiting
      HERTFORDSHIRE,  SG1 4AB,  United Kingdom; Not yet recruiting
      Glasgow,  G4 0SF,  United Kingdom; Not yet recruiting
      Belfast,  BT9 7LJ,  United Kingdom; Not yet recruiting
      Exeter,  EX2 5DW,  United Kingdom; Not yet recruiting
      Cambridge,  CB2 2QQ,  United Kingdom; Not yet recruiting
      Dundee,  DD1 9SY,  United Kingdom; Not yet recruiting
      Peterborough,  PE4 6NA,  United Kingdom; Completed

Study ID Numbers:  BH18387
Record last reviewed:  March 2005
Last Updated:  March 25, 2005
Record first received:  September 3, 2004
ClinicalTrials.gov Identifier:  NCT00090753
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08