Back to resultsA Study Comparing Mircera and Epoetin Beta for the Treatment of Anemia in Dialysis Patients With Chronic Kidney Disease.
Primary Purpose
Anemia
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Epoetin 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 requiring dialysis;
- maintenance hemodialysis or peritoneal dialysis for >=2 weeks before and during screening;
- adequate iron status.
Exclusion Criteria:
- previous epoetin treatment within 8 weeks prior to screening;
- failing renal graft in place;
- bleeding episode necessitating transfusion within 8 weeks prior to screening;
- poorly controlled hypertension;
- previous treatment with Mircera.
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
Hb response rate
Change in Hb concentration between baseline and evaluation period
Secondary Outcome Measures
Hb over time
Time to Hb response
RBC transfusions
AEs, laboratory parameters, vital signs
Serum concentration of Mircera
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00442793
Brief Title
A Study Comparing Mircera and Epoetin Beta for the Treatment of Anemia in Dialysis Patients With Chronic Kidney Disease.
Official Title
A Randomized, Open Label Study Comparing the Effect of Mircera and Epoetin Beta on Hemoglobin Response in Patients With Chronic Kidney Disease Who Are on Dialysis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (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 2 arm study will compare the effect on hemoglobin response of Mircera and epoetin beta, in patients with chronic renal anemia who are on dialysis. Eligible patients will be randomized to receive either Mircera (0.4 micrograms/kg i.v. every 2 weeks) or epoetin beta (3 times weekly, according to approved labelling). 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
265 (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 beta
Intervention Description
As prescribed, 3 times weekly
Intervention Type
Drug
Intervention Name(s)
methoxy polyethylene glycol-epoetin beta [Mircera]
Intervention Description
0.4 micrograms/kg iv every 2 weeks
Primary Outcome Measure Information:
Title
Hb response rate
Time Frame
Weeks 0-24
Title
Change in Hb concentration between baseline and evaluation period
Time Frame
Months 4-6
Secondary Outcome Measure Information:
Title
Hb over time
Time Frame
Throughout study
Title
Time to Hb response
Time Frame
Throughout study
Title
RBC transfusions
Time Frame
Weeks 0-24
Title
AEs, laboratory parameters, vital signs
Time Frame
Throughout study
Title
Serum concentration of Mircera
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 requiring dialysis;
maintenance hemodialysis or peritoneal dialysis for >=2 weeks before and during screening;
adequate iron status.
Exclusion Criteria:
previous epoetin treatment within 8 weeks prior to screening;
failing renal graft in place;
bleeding episode necessitating transfusion within 8 weeks prior to screening;
poorly controlled hypertension;
previous treatment with Mircera.
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
Beijing
ZIP/Postal Code
100050
Country
China
City
Beijing
ZIP/Postal Code
10029
Country
China
City
Beijing
ZIP/Postal Code
100853
Country
China
City
Chengdu
ZIP/Postal Code
610072
Country
China
City
Guangzhou
ZIP/Postal Code
510515
Country
China
City
Guangzhou
Country
China
City
Hangzhou
ZIP/Postal Code
310003
Country
China
City
Nanjing
ZIP/Postal Code
210009
Country
China
City
Shanghai
ZIP/Postal Code
200001
Country
China
City
Shanghai
ZIP/Postal Code
200003
Country
China
City
Shanghai
ZIP/Postal Code
200025
Country
China
City
Shanghai
ZIP/Postal Code
200032
Country
China
City
Shanghai
ZIP/Postal Code
200040
Country
China
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
Learn more about this trial
A Study Comparing Mircera and Epoetin Beta for the Treatment of Anemia in Dialysis Patients With Chronic Kidney Disease.
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