Back to resultsA Study Comparing Maintenance of Hemoglobin Levels, Safety and Tolerability of Once Every 4 Weeks Mircera Versus Epoetin Beta in Dialysis Patients With Chronic Renal Anemia.
Primary Purpose
Anemia
Status
Completed
Phase
Phase 3
Locations
China
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:
- male or female patients, >=18 years of age;
- chronic renal anemia;
- Hb concentration 10.0 - 12.0 g/dL during the screening period;
- continuous subcutaneous maintenance therapy with epoetin at the same dose AND same dosing interval for at least 12 weeks before and throughout screening.
Exclusion Criteria:
- blood transfusion within the previous 8 weeks;
- poorly controlled hypertension;
- significant or acute or chronic bleeding;
- active malignant disease;
- congestive heart failure (NYHA Class IV).
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 between baseline and the EEP
Secondary Outcome Measures
Proportion of patients maintaining average Hb concentration within the target range during the EEP; proportion of patients maintaining Hb concentration between 10-12g/dL throughout the EEP.
Mean time spent in the Hb range 10 - 12g/dL; incidence of red blood cell transfusions during the DTP and EEP.
Incidence of adverse events and serious adverse events; vital signs, laboratory parameters, ECG.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00773331
Brief Title
A Study Comparing Maintenance of Hemoglobin Levels, Safety and Tolerability of Once Every 4 Weeks Mircera Versus Epoetin Beta in Dialysis Patients With Chronic Renal Anemia.
Official Title
An Open Label Randomized Controlled Study to Compare the Efficacy and Safety of Once Every 4 Weeks Administration of Mircera Versus Short-acting Epoetin for the Maintenance of Hemoglobin Levels in Dialysis Patients With Chronic Renal Anemia.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 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 two arm study will compare the maintenance of hemoglobin levels, safety and tolerability of once every 4 weeks subcutaneous administration of Mircera versus epoetin beta in dialysis patients with chronic renal anemia. Patients will be randomized to receive either subcutaneous Mircera (starting dose 120, 200 or 360 micrograms) every 4 weeks or subcutaneous epoetin beta in accordance with the prescribed dosing information. In both groups, the starting dose will be the same as the previous dose of epoetin beta administered in the week preceding first study drug administration. Patients will be treated for 28 weeks with follow up 4 weeks after the last treatment visit. 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
281 (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
Intervention Type
Drug
Intervention Name(s)
methoxy polyethylene glycol-epoetin beta [Mircera]
Intervention Description
120, 200 or 360 micrograms every 4 weeks
Primary Outcome Measure Information:
Title
Change in hemoglobin concentration between baseline and the EEP
Time Frame
Week 20-28
Secondary Outcome Measure Information:
Title
Proportion of patients maintaining average Hb concentration within the target range during the EEP; proportion of patients maintaining Hb concentration between 10-12g/dL throughout the EEP.
Time Frame
Weeks 1-28
Title
Mean time spent in the Hb range 10 - 12g/dL; incidence of red blood cell transfusions during the DTP and EEP.
Time Frame
Weeks 1-28
Title
Incidence of adverse events and serious adverse events; vital signs, laboratory parameters, ECG.
Time Frame
Throughout study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
male or female patients, >=18 years of age;
chronic renal anemia;
Hb concentration 10.0 - 12.0 g/dL during the screening period;
continuous subcutaneous maintenance therapy with epoetin at the same dose AND same dosing interval for at least 12 weeks before and throughout screening.
Exclusion Criteria:
blood transfusion within the previous 8 weeks;
poorly controlled hypertension;
significant or acute or chronic bleeding;
active malignant disease;
congestive heart failure (NYHA Class IV).
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
100034
Country
China
City
Beijing
ZIP/Postal Code
100044
Country
China
City
Beijing
ZIP/Postal Code
100050
Country
China
City
Beijing
ZIP/Postal Code
100083
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
Nanjing
ZIP/Postal Code
210036
Country
China
City
Shanghai
ZIP/Postal Code
200001
Country
China
City
Shanghai
ZIP/Postal Code
200025
Country
China
12. IPD Sharing Statement
Learn more about this trial
A Study Comparing Maintenance of Hemoglobin Levels, Safety and Tolerability of Once Every 4 Weeks Mircera Versus Epoetin Beta in Dialysis Patients With Chronic Renal Anemia.
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