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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

Primary Purpose

Anemia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Methoxy Polyethylene Glycol-Epoetin Beta
Epoetin alfa
Epoetin beta
Darbepoetin alfa
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Methoxy Polyethylene Glycol-Epoetin Beta

Comparator ESA

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change From Baseline in Hemoglobin Concentration to the Last Month of Study Participation
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
See the adverse events section of the results for more information.

Full Information

First Posted
September 3, 2004
Last Updated
February 10, 2012
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT00090753
Brief Title
A Study of Intravenous or Subcutaneous Methoxy Polyethylene Glycol-Epoetin Beta (RO0503821, Mircera) in Chronic Kidney Disease Patients With Renal Anemia
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 Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1228 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Methoxy Polyethylene Glycol-Epoetin Beta
Arm Type
Experimental
Arm Description
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.
Arm Title
Comparator ESA
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Methoxy Polyethylene Glycol-Epoetin Beta
Other Intervention Name(s)
RO0503821, Mircera
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Epoetin alfa
Intervention Description
Epoetin alfa was provided with commercial packaging in English with country-specific labels (10,000 IU, 20,000 IU).
Intervention Type
Drug
Intervention Name(s)
Epoetin beta
Intervention Description
Epoetin beta was provided with commercial packaging in English with country-specific labels (50,000 IU, 100,000 IU).
Intervention Type
Drug
Intervention Name(s)
Darbepoetin alfa
Intervention Description
Darbepoetin alfa was provided with commercial packaging in English with country-specific labels (vials and PFSs in various strengths).
Primary Outcome Measure Information:
Title
Change From Baseline in Hemoglobin Concentration to the Last Month of Study Participation
Description
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.
Time Frame
Baseline to the end of the study (Up to 49 Months)
Secondary Outcome Measure Information:
Title
Percentage of Patients Who Had at Least 1 Adverse Event
Description
See the adverse events section of the results for more information.
Time Frame
From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35211
Country
United States
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36106
Country
United States
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71901
Country
United States
City
Covina
State/Province
California
ZIP/Postal Code
91723
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United States
City
Encino
State/Province
California
ZIP/Postal Code
91356
Country
United States
City
Irvine
State/Province
California
ZIP/Postal Code
92868
Country
United States
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
City
Monterey Park
State/Province
California
ZIP/Postal Code
91754
Country
United States
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
City
Sacramento
State/Province
California
ZIP/Postal Code
95816-5119
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
City
San Francisco
State/Province
California
ZIP/Postal Code
94117
Country
United States
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80260
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United States
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Stamford
State/Province
Connecticut
ZIP/Postal Code
06902
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United States
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
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United States
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
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United States
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Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
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United States
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Augusta
State/Province
Georgia
ZIP/Postal Code
30309
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United States
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Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
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Maywood
State/Province
Illinois
ZIP/Postal Code
60153
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United States
City
South Holland
State/Province
Illinois
ZIP/Postal Code
60473
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United States
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Louisville
State/Province
Kentucky
ZIP/Postal Code
40202-1718
Country
United States
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Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70884
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United States
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Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
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United States
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Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
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United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02135
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United States
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Springfield
State/Province
Massachusetts
ZIP/Postal Code
01107
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United States
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Detroit
State/Province
Michigan
ZIP/Postal Code
48202-2689
Country
United States
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
City
Brooklyn Center
State/Province
Minnesota
ZIP/Postal Code
55430
Country
United States
City
Columbus
State/Province
Mississippi
ZIP/Postal Code
39705
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United States
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
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United States
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63110
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United States
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Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
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United States
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Paterson
State/Province
New Jersey
ZIP/Postal Code
07503
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United States
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Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
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United States
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Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
City
Flushing
State/Province
New York
ZIP/Postal Code
11355
Country
United States
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10128
Country
United States
City
Orchard Park
State/Province
New York
ZIP/Postal Code
14127
Country
United States
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7155
Country
United States
City
Mount Airy
State/Province
North Carolina
ZIP/Postal Code
27030
Country
United States
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0585
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
City
Oregon City
State/Province
Oregon
ZIP/Postal Code
97045
Country
United States
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201-2940
Country
United States
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16502
Country
United States
City
Lewistown
State/Province
Pennsylvania
ZIP/Postal Code
17044
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19106
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29209
Country
United States
City
Orangeburg
State/Province
South Carolina
ZIP/Postal Code
29118
Country
United States
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78758
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77099
Country
United States
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507-1901
Country
United States
City
Salem
State/Province
Virginia
ZIP/Postal Code
24153
Country
United States
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
City
Clayton
ZIP/Postal Code
3186
Country
Australia
City
Gosford
ZIP/Postal Code
2250
Country
Australia
City
Liverpool
ZIP/Postal Code
1871
Country
Australia
City
Parkville
ZIP/Postal Code
3050
Country
Australia
City
Perth
ZIP/Postal Code
6847
Country
Australia
City
Sydney
ZIP/Postal Code
NSW 2148
Country
Australia
City
Woolloongabba
ZIP/Postal Code
4102
Country
Australia
City
Graz
ZIP/Postal Code
8036
Country
Austria
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
City
Gent
ZIP/Postal Code
9000
Country
Belgium
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
City
Liege
ZIP/Postal Code
4000
Country
Belgium
City
Liberec
ZIP/Postal Code
460 63
Country
Czech Republic
City
Ostrava
ZIP/Postal Code
708 52
Country
Czech Republic
City
Plzen
ZIP/Postal Code
304 60
Country
Czech Republic
City
Aalborg
ZIP/Postal Code
9100
Country
Denmark
City
Odense
ZIP/Postal Code
5000
Country
Denmark
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
City
HUS
ZIP/Postal Code
00029
Country
Finland
City
Tampere
ZIP/Postal Code
33521
Country
Finland
City
Bayonne
ZIP/Postal Code
64115
Country
France
City
Bois Guillaume
ZIP/Postal Code
76233
Country
France
City
Bordeaux
ZIP/Postal Code
33076
Country
France
City
Boulogne
ZIP/Postal Code
62321
Country
France
City
Cabestany
ZIP/Postal Code
66330
Country
France
City
Caen
ZIP/Postal Code
14033
Country
France
City
Chambery
ZIP/Postal Code
73001
Country
France
City
Colmar
ZIP/Postal Code
68024
Country
France
City
Hyeres
ZIP/Postal Code
83400
Country
France
City
La Tronche
ZIP/Postal Code
38700
Country
France
City
Limoges
ZIP/Postal Code
87042
Country
France
City
Lyon
ZIP/Postal Code
69437
Country
France
City
Montpellier
ZIP/Postal Code
34295
Country
France
City
Nantes
ZIP/Postal Code
44093
Country
France
City
Nimes
ZIP/Postal Code
30029
Country
France
City
Paris
ZIP/Postal Code
75908
Country
France
City
Perpignan
ZIP/Postal Code
66046
Country
France
City
Poitiers
ZIP/Postal Code
86021
Country
France
City
Saint Ouen
ZIP/Postal Code
93400
Country
France
City
Saint-germain-en-laye
ZIP/Postal Code
78100
Country
France
City
Salouël
ZIP/Postal Code
80480
Country
France
City
Tarbes
ZIP/Postal Code
65013
Country
France
City
Thionville
ZIP/Postal Code
57126
Country
France
City
Toulouse
ZIP/Postal Code
31059
Country
France
City
Tours
ZIP/Postal Code
37044
Country
France
City
Bad Hersfeld
ZIP/Postal Code
36251
Country
Germany
City
Berlin
ZIP/Postal Code
12045
Country
Germany
City
Dortmund
ZIP/Postal Code
44263
Country
Germany
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
City
München
ZIP/Postal Code
80804
Country
Germany
City
Nürnberg
ZIP/Postal Code
90431
Country
Germany
City
Stuttgart
ZIP/Postal Code
70191
Country
Germany
City
Villingen-schwenningen
ZIP/Postal Code
78054
Country
Germany
City
Wiesbaden
ZIP/Postal Code
65191
Country
Germany
City
Wiesloch
ZIP/Postal Code
69168
Country
Germany
City
Wuppertal
ZIP/Postal Code
42103
Country
Germany
City
Alexandroupolis
ZIP/Postal Code
68100
Country
Greece
City
Ioannina
ZIP/Postal Code
45500
Country
Greece
City
Larissa
ZIP/Postal Code
41110
Country
Greece
City
Piraeus
ZIP/Postal Code
18536
Country
Greece
City
Thessaloniki
ZIP/Postal Code
54629
Country
Greece
City
Budapest
ZIP/Postal Code
1076
Country
Hungary
City
Budapest
ZIP/Postal Code
1134
Country
Hungary
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
City
Miskolc
ZIP/Postal Code
3526
Country
Hungary
City
Pecs
ZIP/Postal Code
7624
Country
Hungary
City
Bergamo
ZIP/Postal Code
24128
Country
Italy
City
Cagliari
ZIP/Postal Code
91034
Country
Italy
City
Cremona
ZIP/Postal Code
26100
Country
Italy
City
Cuneo
ZIP/Postal Code
12100
Country
Italy
City
Genova
ZIP/Postal Code
16132
Country
Italy
City
Lecco
ZIP/Postal Code
23900
Country
Italy
City
Livorno
ZIP/Postal Code
57100
Country
Italy
City
Lodi
ZIP/Postal Code
26900
Country
Italy
City
Messina
ZIP/Postal Code
98158
Country
Italy
City
Mestre
ZIP/Postal Code
30174
Country
Italy
City
Modena
ZIP/Postal Code
41100
Country
Italy
City
Pavia
ZIP/Postal Code
27100
Country
Italy
City
Prato
ZIP/Postal Code
50047
Country
Italy
City
Reggio Calabria
ZIP/Postal Code
89100
Country
Italy
City
S Fermo Della Battaglia
ZIP/Postal Code
22020
Country
Italy
City
Venezia
ZIP/Postal Code
30122
Country
Italy
City
Cuernavaca
ZIP/Postal Code
62448
Country
Mexico
City
Mexico City
ZIP/Postal Code
14000
Country
Mexico
City
Heerlen
ZIP/Postal Code
6419 PC
Country
Netherlands
City
Trondheim
ZIP/Postal Code
7006
Country
Norway
City
Panama City
Country
Panama
City
Gdansk
ZIP/Postal Code
80-211
Country
Poland
City
Gdynia
ZIP/Postal Code
81-519
Country
Poland
City
Kielce
ZIP/Postal Code
25-736
Country
Poland
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
City
Lodz
ZIP/Postal Code
90-153
Country
Poland
City
Poznan
ZIP/Postal Code
60-355
Country
Poland
City
Rzeszow
ZIP/Postal Code
35-055
Country
Poland
City
Szczecin
ZIP/Postal Code
70-111
Country
Poland
City
Warszawa
ZIP/Postal Code
02-006
Country
Poland
City
Wolomin
ZIP/Postal Code
05-200
Country
Poland
City
Wroclaw
ZIP/Postal Code
50-417
Country
Poland
City
Setubal
ZIP/Postal Code
2910-446
Country
Portugal
City
Ponce
ZIP/Postal Code
00732
Country
Puerto Rico
City
Moscow
ZIP/Postal Code
123182
Country
Russian Federation
City
Moscow
ZIP/Postal Code
125101
Country
Russian Federation
City
Moscow
ZIP/Postal Code
129110
Country
Russian Federation
City
St Petersburg
ZIP/Postal Code
195067
Country
Russian Federation
City
St Petersburg
ZIP/Postal Code
197089
Country
Russian Federation
City
Cape Town
ZIP/Postal Code
7925
Country
South Africa
City
Durban
Country
South Africa
City
Soweto
Country
South Africa
City
Alcorcon
ZIP/Postal Code
28922
Country
Spain
City
Alicante
ZIP/Postal Code
03010
Country
Spain
City
Almería
ZIP/Postal Code
04009
Country
Spain
City
Badalona
ZIP/Postal Code
08915
Country
Spain
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
City
Bilbao
ZIP/Postal Code
48013
Country
Spain
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
City
Hospitalet de Llobregat
ZIP/Postal Code
08907
Country
Spain
City
La Coruna
ZIP/Postal Code
15006
Country
Spain
City
Lerida
ZIP/Postal Code
25198
Country
Spain
City
Madrid
ZIP/Postal Code
28006
Country
Spain
City
Madrid
ZIP/Postal Code
28007
Country
Spain
City
Madrid
ZIP/Postal Code
28041
Country
Spain
City
Madrid
ZIP/Postal Code
28046
Country
Spain
City
Madrid
ZIP/Postal Code
28222
Country
Spain
City
Madrid
ZIP/Postal Code
28805
Country
Spain
City
Malaga
ZIP/Postal Code
29010
Country
Spain
City
Oviedo
ZIP/Postal Code
33006
Country
Spain
City
Palma de Mallorca
ZIP/Postal Code
07014
Country
Spain
City
Palma de Mallorca
ZIP/Postal Code
07198
Country
Spain
City
Salamanca
ZIP/Postal Code
37008
Country
Spain
City
Santander
ZIP/Postal Code
39008
Country
Spain
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
City
Huddinge
ZIP/Postal Code
14186
Country
Sweden
City
Karlstad
ZIP/Postal Code
65185
Country
Sweden
City
Stockholm
ZIP/Postal Code
18288
Country
Sweden
City
Umea
ZIP/Postal Code
90185
Country
Sweden
City
Aarau
ZIP/Postal Code
5001
Country
Switzerland
City
Lausanne
ZIP/Postal Code
1003
Country
Switzerland
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
City
Taichung
ZIP/Postal Code
407
Country
Taiwan
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
City
Bangkok
Country
Thailand
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
City
Chonburi
Country
Thailand
City
Phitsanulok
ZIP/Postal Code
65000
Country
Thailand
City
Belfast
ZIP/Postal Code
BT9 7LJ
Country
United Kingdom
City
Cambridge
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
City
Carshalton
ZIP/Postal Code
SM5 1AA
Country
United Kingdom
City
Dundee
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
City
Exeter
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
City
Glasgow
ZIP/Postal Code
G4 OSF
Country
United Kingdom
City
Leicester
ZIP/Postal Code
LE5 4PW
Country
United Kingdom
City
London
ZIP/Postal Code
E1 1BB
Country
United Kingdom
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
City
London
ZIP/Postal Code
SE22 8PT
Country
United Kingdom
City
London
ZIP/Postal Code
SW17 0RE
Country
United Kingdom
City
Salford
ZIP/Postal Code
M6 8HD
Country
United Kingdom
City
Swansea
ZIP/Postal Code
SA6 6NL
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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