Back to resultsA Study of Mircera in the Treatment of Anemia in Patients With Chronic Kidney Disease Not on Dialysis
Primary Purpose
Anemia
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
darbepoetin alfa
methoxy polyethylene glycol-epoetin beta [Mircera]
Sponsored by
About this trial
This is an interventional treatment trial for Anemia
Eligibility Criteria
Inclusion Criteria: adult patients >=18 years of age; chronic kidney disease; anemia; not on dialysis therapy; not receiving epoetin. Exclusion Criteria: women who are pregnant, breastfeeding or using unreliable birth control methods; administration of another investigational drug within 4 weeks before screening, or during the study period.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Hemoglobin response rate
Secondary Outcome Measures
Hb concentration over time, time to target Hb response, incidence of RBC transfusions. Vital signs, ECG, adverse events, laboratory values\n\n
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00081471
Brief Title
A Study of Mircera in the Treatment of Anemia in Patients With Chronic Kidney Disease Not on Dialysis
Official Title
A Randomized, Open-label Study of the Effect of Subcutaneous Mircera on Hemoglobin Level/Correction in Non-dialysis Patients With Chronic Kidney Disease
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
July 2006 (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 will assess the efficacy and safety of subcutaneous Mircera in the treatment of renal anemia in patients with chronic kidney disease who are not on dialysis and not 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.
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
Randomized
Enrollment
324 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
darbepoetin alfa
Intervention Description
0.45 micrograms/kg sc (starting dose) weekly
Intervention Type
Drug
Intervention Name(s)
methoxy polyethylene glycol-epoetin beta [Mircera]
Intervention Description
0.6 micrograms/kg sc (starting dose) once every 2 weeks
Primary Outcome Measure Information:
Title
Hemoglobin response rate
Time Frame
Weeks 1-28
Secondary Outcome Measure Information:
Title
Hb concentration over time, time to target Hb response, incidence of RBC transfusions. Vital signs, ECG, adverse events, laboratory values\n\n
Time Frame
Throughout study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adult patients >=18 years of age;
chronic kidney disease;
anemia;
not on dialysis therapy;
not receiving epoetin.
Exclusion Criteria:
women who are pregnant, breastfeeding or using unreliable birth control methods;
administration of another investigational drug within 4 weeks before screening, or during the study period.
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
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
City
Mather
State/Province
California
ZIP/Postal Code
95655
Country
United States
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5114
Country
United States
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06902
Country
United States
City
Bay Pines
State/Province
Florida
ZIP/Postal Code
33744
Country
United States
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
City
Flushing
State/Province
New York
ZIP/Postal Code
11355
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201-2940
Country
United States
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29209
Country
United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
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
Liverpool
ZIP/Postal Code
1871
Country
Australia
City
Parkville
ZIP/Postal Code
3052
Country
Australia
City
Perth
ZIP/Postal Code
6847
Country
Australia
City
Antwerpen
ZIP/Postal Code
2060
Country
Belgium
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
City
Kamloops
State/Province
British Columbia
ZIP/Postal Code
V2C 2T1
Country
Canada
City
New Westminster
State/Province
British Columbia
ZIP/Postal Code
V3L 3W7
Country
Canada
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2H 2A6
Country
Canada
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3V6
Country
Canada
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2G 1N9
Country
Canada
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
City
Scarborough
State/Province
Ontario
ZIP/Postal Code
M1H 3G4
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7K 1N4
Country
Canada
City
Angers
ZIP/Postal Code
49933
Country
France
City
Besancon
ZIP/Postal Code
25030
Country
France
City
Chartres
ZIP/Postal Code
28000
Country
France
City
Colmar
ZIP/Postal Code
68024
Country
France
City
Lille
ZIP/Postal Code
59037
Country
France
City
Lyon
ZIP/Postal Code
69437
Country
France
City
Nantes
ZIP/Postal Code
44035
Country
France
City
Paris
ZIP/Postal Code
75743
Country
France
City
Paris
ZIP/Postal Code
75908
Country
France
City
Perpignan
ZIP/Postal Code
66046
Country
France
City
Salouel
ZIP/Postal Code
80480
Country
France
City
Toulouse
ZIP/Postal Code
31059
Country
France
City
Vandoeuvre-les-nancy
ZIP/Postal Code
54511
Country
France
City
Aschaffenburg
ZIP/Postal Code
63741
Country
Germany
City
Berlin
ZIP/Postal Code
13353
Country
Germany
City
Bonn
ZIP/Postal Code
53127
Country
Germany
City
Dortmund
ZIP/Postal Code
44263
Country
Germany
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
City
Alexandroupolis
ZIP/Postal Code
68100
Country
Greece
City
Athens
ZIP/Postal Code
11527
Country
Greece
City
Ioannina
ZIP/Postal Code
455 00
Country
Greece
City
Piraeus
ZIP/Postal Code
18536
Country
Greece
City
Thessaloniki
ZIP/Postal Code
54629
Country
Greece
City
Cagliari
ZIP/Postal Code
91034
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
Lodi
ZIP/Postal Code
26900
Country
Italy
City
Modena
ZIP/Postal Code
41100
Country
Italy
City
Napoli
ZIP/Postal Code
80131
Country
Italy
City
Padova
ZIP/Postal Code
35128
Country
Italy
City
Pavia
ZIP/Postal Code
27100
Country
Italy
City
Prato
ZIP/Postal Code
50047
Country
Italy
City
Reggio Calabria
ZIP/Postal Code
89124
Country
Italy
City
Roma
ZIP/Postal Code
00184
Country
Italy
City
Amersfoort
ZIP/Postal Code
3818
Country
Netherlands
City
Heerlen
ZIP/Postal Code
6419 PC
Country
Netherlands
City
San Juan
ZIP/Postal Code
00936-5067
Country
Puerto Rico
City
Almería
ZIP/Postal Code
04009
Country
Spain
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
City
Lerida
ZIP/Postal Code
25198
Country
Spain
City
Madrid
ZIP/Postal Code
28041
Country
Spain
City
Madrid
ZIP/Postal Code
28046
Country
Spain
City
Madrid
ZIP/Postal Code
28805
Country
Spain
City
Palma de Mallorca
ZIP/Postal Code
07014
Country
Spain
City
Valencia
ZIP/Postal Code
46017
Country
Spain
City
Boras
ZIP/Postal Code
50142
Country
Sweden
City
Umea
ZIP/Postal Code
90185
Country
Sweden
City
Birmingham
ZIP/Postal Code
B9 5SS
Country
United Kingdom
City
Carshalton
ZIP/Postal Code
SM5 1AA
Country
United Kingdom
City
Leicester
ZIP/Postal Code
LE5 4PW
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
12. IPD Sharing Statement
Learn more about this trial
A Study of Mircera in the Treatment of Anemia in Patients With Chronic Kidney Disease Not on Dialysis
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