Back to resultsA Study of Mircera for the Treatment of Anemia in Dialysis Patients
Primary Purpose
Anemia
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
epoetin
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; dialysis therapy for at least 2 weeks before screening. Exclusion Criteria: women who are pregnant, breastfeeding or using unreliable birth control methods; administration of any investigational drug within 4 weeks before screening.
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 over time, time to target Hb response, incidence of RBC transfusions. Vital signs, ECG, AEs, laboratory values\n
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00077597
Brief Title
A Study of Mircera for the Treatment of Anemia in Dialysis Patients
Official Title
A Randomized, Open-label Study of the Effect of Intravenous Mircera on Hemoglobin Level/Correction in Dialysis Patients With Chronic Kidney Disease
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
June 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 Mircera given intravenously in the treatment of renal anemia in chronic kidney disease patients on dialysis who are not currently 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
182 (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
Intervention Description
3 times a week iv, as prescribed.
Intervention Type
Drug
Intervention Name(s)
methoxy polyethylene glycol-epoetin beta [Mircera]
Intervention Description
0.4 micrograms/kg iv (starting dose) once every 2 weeks
Primary Outcome Measure Information:
Title
Hemoglobin response rate
Time Frame
Weeks 1-24
Secondary Outcome Measure Information:
Title
Hb over time, time to target Hb response, incidence of RBC transfusions. Vital signs, ECG, AEs, laboratory values\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 renal anemia;
dialysis therapy for at least 2 weeks before screening.
Exclusion Criteria:
women who are pregnant, breastfeeding or using unreliable birth control methods;
administration of any investigational drug within 4 weeks before screening.
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
Davis
State/Province
California
ZIP/Postal Code
95616
Country
United States
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80260
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30901
Country
United States
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01107
Country
United States
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202-2689
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
10128
Country
United States
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
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
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507-1901
Country
United States
City
Curitiba
ZIP/Postal Code
81050-090
Country
Brazil
City
Ribeirão Preto
ZIP/Postal Code
14025-170
Country
Brazil
City
Sao Paulo
ZIP/Postal Code
01307-001
Country
Brazil
City
Sao Paulo
ZIP/Postal Code
04039-000
Country
Brazil
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1R9
Country
Canada
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3V6
Country
Canada
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 3N6
Country
Canada
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
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
Liberec
ZIP/Postal Code
460 63
Country
Czech Republic
City
Praha
ZIP/Postal Code
169 00
Country
Czech Republic
City
Usti Nad Labem
ZIP/Postal Code
401 13
Country
Czech Republic
City
Alexandroupolis
ZIP/Postal Code
68100
Country
Greece
City
Larissa
ZIP/Postal Code
41 110
Country
Greece
City
Nikea
ZIP/Postal Code
18354
Country
Greece
City
Thessaloniki
ZIP/Postal Code
54629
Country
Greece
City
Bergen
ZIP/Postal Code
5021
Country
Norway
City
Oslo
ZIP/Postal Code
0407
Country
Norway
City
Gdansk
ZIP/Postal Code
80-211
Country
Poland
City
Gdynia
ZIP/Postal Code
81-519
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
Szczecin
ZIP/Postal Code
70-111
Country
Poland
City
Wolomin
ZIP/Postal Code
05-200
Country
Poland
City
Wroclaw
ZIP/Postal Code
50-417
Country
Poland
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
Johannesburg
ZIP/Postal Code
2193
Country
South Africa
City
Soweto
Country
South Africa
City
Bilbao
ZIP/Postal Code
48013
Country
Spain
City
Santander
ZIP/Postal Code
39008
Country
Spain
City
Karlstad
ZIP/Postal Code
65185
Country
Sweden
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
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
12. IPD Sharing Statement
Citations:
PubMed Identifier
18037099
Citation
Klinger M, Arias M, Vargemezis V, Besarab A, Sulowicz W, Gerntholtz T, Ciechanowski K, Dougherty FC, Beyer U. Efficacy of intravenous methoxy polyethylene glycol-epoetin beta administered every 2 weeks compared with epoetin administered 3 times weekly in patients treated by hemodialysis or peritoneal dialysis: a randomized trial. Am J Kidney Dis. 2007 Dec;50(6):989-1000. doi: 10.1053/j.ajkd.2007.08.013.
Results Reference
derived
Learn more about this trial
A Study of Mircera for the Treatment of Anemia in Dialysis Patients
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