Back to resultsA Study of Intravenous or Subcutaneous Mircera for the Treatment of Anemia in Dialysis Patients
Primary Purpose
Anemia
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
epoetin alfa or beta
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 renal anemia; on dialysis therapy for at least 12 weeks before screening; receiving iv or sc epoetin for at least 8 weeks before screening. 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
Change in hemoglobin concentration
Secondary Outcome Measures
Number of patients maintaining average Hb concentration within +/- 1g/dL of average baseline Hb concentration
RBC transfusions
AEs, laboratory parameters, vital signs
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00081484
Brief Title
A Study of Intravenous or Subcutaneous Mircera for the Treatment of Anemia in Dialysis Patients
Official Title
A Randomized, Open-label Study of the Effect of Maintenance Mircera Administered With Pre-filled Syringes on Hemoglobin Levels in Anemic 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
March 2006 (Actual)
Study Completion Date
March 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 intravenous (iv) or subcutaneous (sc) Mircera, administered with pre-filled syringes, as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv or sc epoetin. The anticipated time on study treatment is 3-12 months 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
336 (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)
epoetin alfa or beta
Intervention Description
iv or sc, as prescribed
Intervention Type
Drug
Intervention Name(s)
methoxy polyethylene glycol-epoetin beta [Mircera]
Intervention Description
30, 50 or 90 micrograms iv or sc (starting dose) every 2 weeks
Primary Outcome Measure Information:
Title
Change in hemoglobin concentration
Time Frame
Weeks 1-36
Secondary Outcome Measure Information:
Title
Number of patients maintaining average Hb concentration within +/- 1g/dL of average baseline Hb concentration
Time Frame
Weeks 29-36
Title
RBC transfusions
Time Frame
Weeks 1-36
Title
AEs, laboratory parameters, vital signs
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 renal anemia;
on dialysis therapy for at least 12 weeks before screening;
receiving iv or sc epoetin for at least 8 weeks before screening.
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
Covina
State/Province
California
ZIP/Postal Code
91723
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
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33617
Country
United States
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
City
South Holland
State/Province
Illinois
ZIP/Postal Code
60473
Country
United States
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70884
Country
United States
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
City
Columbus
State/Province
Mississippi
ZIP/Postal Code
39705
Country
United States
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
City
Flushing
State/Province
New York
ZIP/Postal Code
11355
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
City
Orchard Park
State/Province
New York
ZIP/Postal Code
14127
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
City
Oregon City
State/Province
Oregon
ZIP/Postal Code
97045
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
Columbia
State/Province
South Carolina
ZIP/Postal Code
29209
Country
United States
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507-1901
Country
United States
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 7W9
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
City
Aix En Provence
ZIP/Postal Code
13616
Country
France
City
Chambery
ZIP/Postal Code
73011
Country
France
City
Hyeres
ZIP/Postal Code
83400
Country
France
City
Le Kremlin-bicetre
ZIP/Postal Code
94275
Country
France
City
Nantes
ZIP/Postal Code
44093
Country
France
City
Paris
ZIP/Postal Code
75970
Country
France
City
Rouen
ZIP/Postal Code
76031
Country
France
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
Como
ZIP/Postal Code
22100
Country
Italy
City
Modena
ZIP/Postal Code
41100
Country
Italy
City
Pavia
ZIP/Postal Code
27100
Country
Italy
City
Rzeszow
ZIP/Postal Code
35-055
Country
Poland
City
Warszawa
ZIP/Postal Code
02-006
Country
Poland
City
Carnaxide
ZIP/Postal Code
2799-523
Country
Portugal
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
City
Setubal
ZIP/Postal Code
2910-446
Country
Portugal
City
Ponce
ZIP/Postal Code
00732
Country
Puerto Rico
City
San Juan
ZIP/Postal Code
00936-5067
Country
Puerto Rico
City
Alicante
ZIP/Postal Code
03010
Country
Spain
City
Madrid
ZIP/Postal Code
28007
Country
Spain
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
City
Taichung
ZIP/Postal Code
407
Country
Taiwan
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
City
Bangkok
Country
Thailand
City
Glasgow
ZIP/Postal Code
G4 OSF
Country
United Kingdom
City
Hertford
ZIP/Postal Code
SG1 4AB
Country
United Kingdom
City
London
ZIP/Postal Code
E1 1BB
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 Mircera for the Treatment of Anemia in Dialysis Patients
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