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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00090753
First received: September 3, 2004
Last updated: February 10, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Anemia
Drug: Methoxy Polyethylene Glycol-Epoetin Beta
Drug: Epoetin alfa
Drug: Epoetin beta
Drug: Darbepoetin alfa
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Change From Baseline in Hemoglobin Concentration to the Last Month of Study Participation [ Time Frame: Baseline to the end of the study (Up to 49 Months) ] [ Designated as safety issue: No ]
    Blood samples were collected at each study visit, that is, every 4 weeks for the first 12 weeks, every 12 weeks until week 105 of the first study period, every 3 months thereafter, and at the end of study or the last visit if the patient discontinued the study prematurely.


Secondary Outcome Measures:
  • Percentage of Patients Who Had at Least 1 Adverse Event [ Time Frame: From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months) ] [ Designated as safety issue: Yes ]
    See the adverse events section of the results for more information.


Enrollment: 1228
Study Start Date: October 2004
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Methoxy Polyethylene Glycol-Epoetin Beta
Patients received the same weekly dose of methoxy polyethylene glycol-epoetin beta via the same route of administration (iv or sc) as they received in the Phase II or Phase III study that qualified the patient for participation in this study. Methoxy polyethylene glycol-epoetin beta was administered every 2 or every 4 weeks in the initial 104-week treatment period. Patients on a 4-week dosing interval were switched to once-monthly administration in the 24-month extension phase. The dose of methoxy polyethylene glycol-epoetin beta was adjusted to maintain the patient's hemoglobin (Hb) within a target range of 11 to 13 g/dL.
Drug: Methoxy Polyethylene Glycol-Epoetin Beta
Methoxy polyethylene glycol-epoetin beta was provided as a sterile single-use injectable solution in 2-mL glass vials containing 1 mL solution or in single-use sterile pre-filled syringes (PFSs) containing 0.3 mL or 0.6 mL injectable solution. The injectable solution was available in vials with the following strengths: 50, 100, 200, 400, and 1000 μg/mL. The injectable solution was available in PFSs with the following strengths: 30, 40, 50, 60, 75, 100, 120, 150, 200, and 250 μg/0.3 mL; and 360 and 400 μg/0.6 mL.
Other Names:
  • RO0503821
  • Mircera
Active Comparator: Comparator ESA
Patients received the same comparator ESA [epoetin alfa, epoetin beta, or darbepoetin alfa] at the same weekly dose and dosing interval via the same route of administration (iv or sc) as they received in the Phase III study that qualified the patient for participation in this study. The dose of the comparator drug was adjusted to maintain the patient's Hb within a target range of 11 to 13 g/dL. Of the 480 patients in the comparator drug group, 170 received darbepoetin alfa, 134 received epoetin alfa, and 176 received epoetin beta.
Drug: Epoetin alfa
Epoetin alfa was provided with commercial packaging in English with country-specific labels (10,000 IU, 20,000 IU).
Drug: Epoetin beta
Epoetin beta was provided with commercial packaging in English with country-specific labels (50,000 IU, 100,000 IU).
Drug: Darbepoetin alfa
Darbepoetin alfa was provided with commercial packaging in English with country-specific labels (vials and PFSs in various strengths).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00090753

  Hide Study Locations
Locations
United States, Alabama
Birmingham, Alabama, United States, 35211
Mobile, Alabama, United States, 36608
Montgomery, Alabama, United States, 36106
United States, Arkansas
Hot Springs, Arkansas, United States, 71901
United States, California
Covina, California, United States, 91723
Encino, California, United States, 91356
Irvine, California, United States, 92868
Los Alamitos, California, United States, 90720
Los Angeles, California, United States, 90095
Los Angeles, California, United States, 90073
Monterey Park, California, United States, 91754
Mountain View, California, United States, 94040
Sacramento, California, United States, 95816-5119
San Diego, California, United States, 92123
San Diego, California, United States, 92120
San Francisco, California, United States, 94117
Stanford, California, United States, 94305
United States, Colorado
Colorado Springs, Colorado, United States, 80909
Denver, Colorado, United States, 80262
Lakewood, Colorado, United States, 80260
United States, Connecticut
Stamford, Connecticut, United States, 06902
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, Hawaii
Honolulu, Hawaii, United States, 96813
United States, Illinois
Maywood, Illinois, United States, 60153
South Holland, Illinois, United States, 60473
United States, Kentucky
Louisville, Kentucky, United States, 40202-1718
United States, Louisiana
Baton Rouge, Louisiana, United States, 70884
Shreveport, Louisiana, United States, 71101
United States, Massachusetts
Boston, Massachusetts, United States, 02115
Boston, Massachusetts, United States, 02135
Springfield, Massachusetts, United States, 01107
United States, Michigan
Detroit, Michigan, United States, 48202-2689
Detroit, Michigan, United States, 48236
Kalamazoo, Michigan, United States, 49007
United States, Minnesota
Brooklyn Center, Minnesota, United States, 55430
United States, Mississippi
Columbus, Mississippi, United States, 39705
Tupelo, Mississippi, United States, 38801
United States, Missouri
St Louis, Missouri, United States, 63110
United States, New Jersey
Hackensack, New Jersey, United States, 07601
Paterson, New Jersey, United States, 07503
United States, New Mexico
Albuquerque, New Mexico, United States, 87131
United States, New York
Bronx, New York, United States, 10467
Brooklyn, New York, United States, 11203
Flushing, New York, United States, 11355
Great Neck, New York, United States, 11021
Mineola, New York, United States, 11501
New York, New York, United States, 10021
New York, New York, United States, 10128
Orchard Park, New York, United States, 14127
United States, North Carolina
Chapel Hill, North Carolina, United States, 27599-7155
Mount Airy, North Carolina, United States, 27030
Raleigh, North Carolina, United States, 27609
United States, Ohio
Cincinnati, Ohio, United States, 45267-0585
Cleveland, Ohio, United States, 44109
Toledo, Ohio, United States, 43606
United States, Oregon
Oregon City, Oregon, United States, 97045
Portland, Oregon, United States, 97210
Portland, Oregon, United States, 97201-2940
United States, Pennsylvania
Allentown, Pennsylvania, United States, 18103
Erie, Pennsylvania, United States, 16502
Lewistown, Pennsylvania, United States, 17044
Philadelphia, Pennsylvania, United States, 19140
Philadelphia, Pennsylvania, United States, 19106
Philadelphia, Pennsylvania, United States, 19141
Pittsburgh, Pennsylvania, United States, 15224
United States, South Carolina
Columbia, South Carolina, United States, 29209
Orangeburg, South Carolina, United States, 29118
United States, Tennessee
Chattanooga, Tennessee, United States, 37404
Nashville, Tennessee, United States, 37232
Nashville, Tennessee, United States, 37205
United States, Texas
Austin, Texas, United States, 78758
Dallas, Texas, United States, 75216
Houston, Texas, United States, 77099
Houston, Texas, United States, 77054
Houston, Texas, United States, 77030
United States, Vermont
Burlington, Vermont, United States, 05401
United States, Virginia
Fairfax, Virginia, United States, 22031
Norfolk, Virginia, United States, 23507-1901
Salem, Virginia, United States, 24153
United States, West Virginia
Morgantown, West Virginia, United States, 26506
Australia
Clayton, Australia, 3186
Gosford, Australia, 2250
Liverpool, Australia, 1871
Parkville, Australia, 3050
Perth, Australia, 6847
Sydney, Australia, NSW 2148
Woolloongabba, Australia, 4102
Austria
Graz, Austria, 8036
Belgium
Aalst, Belgium, 9300
Bruxelles, Belgium, 1200
Edegem, Belgium, 2650
Gent, Belgium, 9000
Hasselt, Belgium, 3500
Leuven, Belgium, 3000
Liege, Belgium, 4000
Czech Republic
Liberec, Czech Republic, 460 63
Ostrava, Czech Republic, 708 52
Plzen, Czech Republic, 304 60
Denmark
Aalborg, Denmark, 9100
Odense, Denmark, 5000
Roskilde, Denmark, 4000
Finland
HUS, Finland, 00029
Tampere, Finland, 33521
France
Bayonne, France, 64115
Bois Guillaume, France, 76233
Bordeaux, France, 33076
Boulogne, France, 62321
Cabestany, France, 66330
Caen, France, 14033
Chambery, France, 73001
Colmar, France, 68024
Hyeres, France, 83400
La Tronche, France, 38700
Limoges, France, 87042
Lyon, France, 69437
Montpellier, France, 34295
Nantes, France, 44093
Nimes, France, 30029
Paris, France, 75908
Perpignan, France, 66046
Poitiers, France, 86021
Saint Ouen, France, 93400
Saint-germain-en-laye, France, 78100
Salouël, France, 80480
Tarbes, France, 65013
Thionville, France, 57126
Toulouse, France, 31059
Tours, France, 37044
Germany
Bad Hersfeld, Germany, 36251
Berlin, Germany, 12045
Dortmund, Germany, 44263
Erlangen, Germany, 91054
München, Germany, 80804
Nürnberg, Germany, 90431
Stuttgart, Germany, 70191
Villingen-schwenningen, Germany, 78054
Wiesbaden, Germany, 65191
Wiesloch, Germany, 69168
Wuppertal, Germany, 42103
Greece
Alexandroupolis, Greece, 68100
Ioannina, Greece, 45500
Larissa, Greece, 41110
Piraeus, Greece, 18536
Thessaloniki, Greece, 54629
Hungary
Budapest, Hungary, 1134
Budapest, Hungary, 1076
Debrecen, Hungary, 4032
Miskolc, Hungary, 3526
Pecs, Hungary, 7624
Italy
Bergamo, Italy, 24128
Cagliari, Italy, 91034
Cremona, Italy, 26100
Cuneo, Italy, 12100
Genova, Italy, 16132
Lecco, Italy, 23900
Livorno, Italy, 57100
Lodi, Italy, 26900
Messina, Italy, 98158
Mestre, Italy, 30174
Modena, Italy, 41100
Pavia, Italy, 27100
Prato, Italy, 50047
Reggio Calabria, Italy, 89100
S Fermo Della Battaglia, Italy, 22020
Venezia, Italy, 30122
Mexico
Cuernavaca, Mexico, 62448
Mexico City, Mexico, 14000
Netherlands
Heerlen, Netherlands, 6419 PC
Norway
Trondheim, Norway, 7006
Panama
Panama City, Panama
Poland
Gdansk, Poland, 80-211
Gdynia, Poland, 81-519
Kielce, Poland, 25-736
Krakow, Poland, 31-501
Lodz, Poland, 90-153
Poznan, Poland, 60-355
Rzeszow, Poland, 35-055
Szczecin, Poland, 70-111
Warszawa, Poland, 02-006
Wolomin, Poland, 05-200
Wroclaw, Poland, 50-417
Portugal
Setubal, Portugal, 2910-446
Puerto Rico
Ponce, Puerto Rico, 00732
Russian Federation
Moscow, Russian Federation, 125101
Moscow, Russian Federation, 123182
Moscow, Russian Federation, 129110
St Petersburg, Russian Federation, 195067
St Petersburg, Russian Federation, 197089
South Africa
Cape Town, South Africa, 7925
Durban, South Africa
Soweto, South Africa
Spain
Alcorcon, Spain, 28922
Alicante, Spain, 03010
Almería, Spain, 04009
Badalona, Spain, 08915
Barcelona, Spain, 08003
Barcelona, Spain, 08036
Barcelona, Spain, 08035
Bilbao, Spain, 48013
Córdoba, Spain, 14004
Hospitalet de Llobregat, Spain, 08907
La Coruna, Spain, 15006
Lerida, Spain, 25198
Madrid, Spain, 28007
Madrid, Spain, 28222
Madrid, Spain, 28041
Madrid, Spain, 28046
Madrid, Spain, 28805
Madrid, Spain, 28006
Malaga, Spain, 29010
Oviedo, Spain, 33006
Palma de Mallorca, Spain, 07198
Palma de Mallorca, Spain, 07014
Salamanca, Spain, 37008
Santander, Spain, 39008
Santiago de Compostela, Spain, 15706
Sevilla, Spain, 41013
Sweden
Huddinge, Sweden, 14186
Karlstad, Sweden, 65185
Stockholm, Sweden, 18288
Umea, Sweden, 90185
Switzerland
Aarau, Switzerland, 5001
Lausanne, Switzerland, 1003
Lausanne, Switzerland, 1011
Taiwan
Taichung, Taiwan, 407
Taipei, Taiwan, 100
Thailand
Bangkok, Thailand, 10400
Bangkok, Thailand, 10330
Bangkok, Thailand
Bangkok, Thailand, 10700
Chiang Mai, Thailand, 50200
Chonburi, Thailand
Phitsanulok, Thailand, 65000
United Kingdom
Belfast, United Kingdom, BT9 7LJ
Cambridge, United Kingdom, CB2 2QQ
Carshalton, United Kingdom, SM5 1AA
Dundee, United Kingdom, DD1 9SY
Exeter, United Kingdom, EX2 5DW
Glasgow, United Kingdom, G4 OSF
Leicester, United Kingdom, LE5 4PW
London, United Kingdom, SE22 8PT
London, United Kingdom, SW17 0RE
London, United Kingdom, E1 1BB
London, United Kingdom, SE1 9RT
Salford, United Kingdom, M6 8HD
Swansea, United Kingdom, SA6 6NL
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00090753     History of Changes
Other Study ID Numbers: BH18387
Study First Received: September 3, 2004
Results First Received: December 1, 2011
Last Updated: February 10, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Anemia
Renal Insufficiency, Chronic
Hematologic Diseases
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Darbepoetin alfa
Epoetin Alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014