Back to resultsA Study of Once-Monthly Intravenous Mircera in Hemodialysis Patients With Chronic Renal Anemia.
Primary Purpose
Anemia
Status
Withdrawn
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
methoxy polyethylene glycol-epoetin beta
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;
- regular long-term hemodialysis therapy with the same mode of dialysis for >=3 months;
- continuous iv or sc maintenance ESA treatment during previous 2 months.
Exclusion Criteria:
- transfusion of red blood cells during previous 2 months;
- significant acute or chronic bleeding, such as overt gastrointestinal bleeding;
- active malignant disease (except non-melanoma skin cancer).
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Percentage of patients maintaining average Hb concentration within target range during evaluation period
Secondary Outcome Measures
Change in Hb concentration between reference and evaluation period; mean time spent in, and percentage of patients maintaining Hb within target range
Dose adjustments; RBC transfusions
AEs, laboratory parameters, vital signs
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00560547
Brief Title
A Study of Once-Monthly Intravenous Mircera in Hemodialysis Patients With Chronic Renal Anemia.
Official Title
An Open Label Study to Assess the Maintenance of Hemoglobin Levels, Safety and Tolerability of Once Monthly Administration of Mircera in Hemodialysis Patients With Chronic Renal Anemia.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Withdrawn
Why Stopped
The study was cancelled before any patients were enrolled, due to operational reasons.
Study Start Date
October 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
This single arm study will assess the long-term maintenance of hemoglobin levels, safety and tolerability of once-monthly intravenous administration of Mircera in hemodialysis patients with chronic renal anemia. Patients currently receiving darboepoetin alfa or epoetin alfa maintenance treatment will receive intravenous Mircera at a starting dose of 120, 200 or 360 micrograms/4 weeks (based on the ESA dose administered on week-1). Subsequent doses will be adjusted to maintain hemoglobin levels within the target range of 10.5-12.5g/dL. 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
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
methoxy polyethylene glycol-epoetin beta
Other Intervention Name(s)
Mircera
Intervention Description
120, 200 or 360 micrograms / 4 weeks iv (starting dose)
Primary Outcome Measure Information:
Title
Percentage of patients maintaining average Hb concentration within target range during evaluation period
Time Frame
Weeks 17-24
Secondary Outcome Measure Information:
Title
Change in Hb concentration between reference and evaluation period; mean time spent in, and percentage of patients maintaining Hb within target range
Time Frame
Weeks 17-24
Title
Dose adjustments; RBC transfusions
Time Frame
Throughout study
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;
regular long-term hemodialysis therapy with the same mode of dialysis for >=3 months;
continuous iv or sc maintenance ESA treatment during previous 2 months.
Exclusion Criteria:
transfusion of red blood cells during previous 2 months;
significant acute or chronic bleeding, such as overt gastrointestinal bleeding;
active malignant disease (except non-melanoma skin cancer).
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
Aalborg
ZIP/Postal Code
9100
Country
Denmark
City
Fredericia
ZIP/Postal Code
7000
Country
Denmark
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
A Study of Once-Monthly Intravenous Mircera in Hemodialysis Patients With Chronic Renal Anemia.
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