Back to resultsA Study of Monthly Subcutaneous or Intravenous Mircera in Dialysis Patients With Chronic Renal Anaemia
Primary Purpose
Anemia
Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Dialysis
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 anaemia
- haemoglobin 10.0-12.0g/dl at screening
- adequate iron status
- continuous stable ESA (erythropoietic stimulating agent) therapy for >/= 2 months
- regular haemodialysis or regular peritoneal dialysis for >/= 3 months
Exclusion Criteria:
- uncontrolled hypertension
- haemoglobinopathy
- anaemia due to haemolysis
- pure red cell aplasia (PRCA)
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single Arm
Arm Description
Outcomes
Primary Outcome Measures
Percentage of Participants Maintaining Average Hemoglobin (Hb) Concentration Within the Target Range
Percentage of participants who maintained the Hb concentration within target range (between 10.0 and 12.0 grams per deciliter [g/dL]) throughout the treatment period were reported.
Secondary Outcome Measures
Mean Monthly Hb Values
The baseline (reference) hemoglobin was defined as the average of the three assessments recorded during the screening and baseline visits (Week -2, -1, and 0).
Change in Hb Concentration Between Reference and Treatment Period
The baseline (reference) hemoglobin was defined as the average of the three assessments recorded during the screening and baseline visits (Week -2, -1, and 0).
Mean Time Participants Spent Having Hb Concentration Within Target Range
Target Hb concentration was between 10.0 and 12.0 g/dL.
Percentage of Participants Requiring Dose Adjustments
Dose adjustment included: Dose Increase; No Change; and Dose Decreased. Participants who did not have this data available are reported as Not Done. Results are reported for overall treatment arm.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01156363
Brief Title
A Study of Monthly Subcutaneous or Intravenous Mircera in Dialysis Patients With Chronic Renal Anaemia
Official Title
A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Once-monthly Administration of Subcutaneous and Intravenous MIRCERA® for the Maintenance of Haemoglobin Levels in Dialysis Patients With Chronic Renal Anaemia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (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 open label, single arm study will assess the efficacy for long-term maintenance of haemoglobin levels and the safety and tolerability of methoxy polyethylene glycol-epoetin beta [Mircera] in dialysis patients with chronic renal anaemia. Patients on regular long-term haemodialysis or peritoneal dialysis will receive monthly subcutaneous or intravenous Mircera for 6 months. Target sample size is <200 patients.
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 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Arm
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Dialysis
Intervention Description
regular haemodialysis or peritoneal dialysis
Intervention Type
Drug
Intervention Name(s)
methoxy polyethylene glycol-epoetin beta [Mircera]
Intervention Description
once monthly, subcutaneously or intravenously, for 32 weeks
Primary Outcome Measure Information:
Title
Percentage of Participants Maintaining Average Hemoglobin (Hb) Concentration Within the Target Range
Description
Percentage of participants who maintained the Hb concentration within target range (between 10.0 and 12.0 grams per deciliter [g/dL]) throughout the treatment period were reported.
Time Frame
Weeks 1 to 32
Secondary Outcome Measure Information:
Title
Mean Monthly Hb Values
Description
The baseline (reference) hemoglobin was defined as the average of the three assessments recorded during the screening and baseline visits (Week -2, -1, and 0).
Time Frame
Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8
Title
Change in Hb Concentration Between Reference and Treatment Period
Description
The baseline (reference) hemoglobin was defined as the average of the three assessments recorded during the screening and baseline visits (Week -2, -1, and 0).
Time Frame
Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8
Title
Mean Time Participants Spent Having Hb Concentration Within Target Range
Description
Target Hb concentration was between 10.0 and 12.0 g/dL.
Time Frame
Weeks 1 to 32
Title
Percentage of Participants Requiring Dose Adjustments
Description
Dose adjustment included: Dose Increase; No Change; and Dose Decreased. Participants who did not have this data available are reported as Not Done. Results are reported for overall treatment arm.
Time Frame
Baseline to Month 1; Month 1 to 2; Month 2 to 3; Month 3 to 4; Month 4 to 5; Month 5 to 6; Month 6 to 7; Month 7 to 8
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 anaemia
haemoglobin 10.0-12.0g/dl at screening
adequate iron status
continuous stable ESA (erythropoietic stimulating agent) therapy for >/= 2 months
regular haemodialysis or regular peritoneal dialysis for >/= 3 months
Exclusion Criteria:
uncontrolled hypertension
haemoglobinopathy
anaemia due to haemolysis
pure red cell aplasia (PRCA)
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
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
City
New Taiepei City
Country
Taiwan
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
A Study of Monthly Subcutaneous or Intravenous Mircera in Dialysis Patients With Chronic Renal Anaemia
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