Back to resultsA Study of Intravenous Mircera for the Correction of Anemia in Dialysis Patients.
Primary Purpose
Anemia
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
methoxy polyethylene glycol-epoetin beta [RO0503821, Mircera]
Epoetin
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;
- maintenance hemodialysis or peritoneal dialysis for >=2 weeks before screening, and during screening period.
Exclusion Criteria:
- previous therapy with epoetin within 8 weeks prior to screening;
- overt gastrointestinal bleeding within 8 weeks before screening or during screening period;
- RBC transfusions within 8 weeks before screening or during screening period;
- active malignant disease except non-melanoma skin cancer.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Correction Phase: CERA
Correction Phase: Epoetin Beta
Arm Description
Outcomes
Primary Outcome Measures
Percentage of Participants Who Achieved Hemoglobin Response up to Week 24
Hemoglobin (Hb) response was defined as increase of Hb by at least 1 g/dL compared with baseline and Hb>/=11 g/dL without red blood cell transfusion during 24-week correction phase. The average baseline value was estimated by the mean of all values recorded between the day of first study dose and the previous 20 days. The percentage of participants who achieved Hb response is presented
Secondary Outcome Measures
Mean Change From Baseline in Hemoglobin Concentration at Week 24
Mean hemoglobin levels and their changes in correction phase from baseline were presented. Baseline is defined as Day 1 visit. The mean Hb concentration from Baseline at week 24 was calculated by subtracting the baseline Hb concentration value from the week 24 value
Median Time in Which Hemoglobin Value Was Maintained Within Target Range of >/= 11g/dL up to Week 24
Median time during the correction period in which Hb value was maintained within target range of >/= 11.0 g/dL and an increase in hemoglobin from baseline >/= 1.0 g/dL was reported.
Number of Participants Who Received Red Blood Cells Transfusions up to Week 49
The number of participants who received at least 1 red blood cell transfusion during the study is presented. RBC transfusions was given in case of medical need, i.e., in severely anemic participants with recognized symptoms or signs of anemia (e.g., in participants with acute blood loss, with severe angina, or whose Hb decreases to critical levels)
Number of Participants With Any Adverse Events and Serious Adverse Events
An adverse event (AE) was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment. A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Number of participants with at least one AE and SAE were reported.
Mean Change From Baseline in Vital Signs: Systolic Blood Pressure and Diastolic Blood Pressure up to Week 24
Change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) at Baseline and end of correction phase (Week 24) is presented. SBP and DBP were determined both before and after the dialysis session for participants. Baseline is defined as Day 1 visit. One participant from CERA group and two participants from Epoetin Beta group did not receive any study medication and were excluded from the safety analysis.
Mean Change From Baseline in Vital Sign: Heart Rate Measurements up to Week 24
Heart rate was measured before blood sampling for all participants and before the dialysis session. Baseline is defined as Day 1. One participant from CERA group and two participants from Epoetin Beta group did not receive any study medication and were excluded from the safety analysis.
Number of Participants With Abnormal Changes in Electrocardiogram up to Week 24
Twelve-lead ECG was recorded before or after the dialysis session. Number of participants with abnormal changes in electrocardiogram observed at any time point was reported. One participant from CERA group and two participants from Epoetin Beta group did not receive any study medication and were excluded from the safety analysis.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00546481
Brief Title
A Study of Intravenous Mircera for the Correction of Anemia in Dialysis Patients.
Official Title
An Open-label, Randomized, Multi-center, Parallel Group Study to Demonstrate Correction of Anemia Using Intravenous Injections of RO0503821 in Patients With Chronic Kidney Disease Who Are on Dialysis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (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 evaluate the efficacy of intravenous Mircera treatment for the correction of anemia in patients with chronic kidney disease who are on dialysis. Patients will be randomized to receive either Mircera 0.6 micrograms/kg i.v. every 2 weeks, or epoetin 3 times per week i.v. according to approved treatment recommendations. 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
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Correction Phase: CERA
Arm Type
Experimental
Arm Title
Correction Phase: Epoetin Beta
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
methoxy polyethylene glycol-epoetin beta [RO0503821, Mircera]
Intervention Description
0.6 micrograms/kg every 2 weeks
Intervention Type
Drug
Intervention Name(s)
Epoetin
Intervention Description
As prescribed, iv, 3 times weekly
Primary Outcome Measure Information:
Title
Percentage of Participants Who Achieved Hemoglobin Response up to Week 24
Description
Hemoglobin (Hb) response was defined as increase of Hb by at least 1 g/dL compared with baseline and Hb>/=11 g/dL without red blood cell transfusion during 24-week correction phase. The average baseline value was estimated by the mean of all values recorded between the day of first study dose and the previous 20 days. The percentage of participants who achieved Hb response is presented
Time Frame
Up to Week 24
Secondary Outcome Measure Information:
Title
Mean Change From Baseline in Hemoglobin Concentration at Week 24
Description
Mean hemoglobin levels and their changes in correction phase from baseline were presented. Baseline is defined as Day 1 visit. The mean Hb concentration from Baseline at week 24 was calculated by subtracting the baseline Hb concentration value from the week 24 value
Time Frame
From Baseline (Day 1) to Week 24
Title
Median Time in Which Hemoglobin Value Was Maintained Within Target Range of >/= 11g/dL up to Week 24
Description
Median time during the correction period in which Hb value was maintained within target range of >/= 11.0 g/dL and an increase in hemoglobin from baseline >/= 1.0 g/dL was reported.
Time Frame
Up to Week 24
Title
Number of Participants Who Received Red Blood Cells Transfusions up to Week 49
Description
The number of participants who received at least 1 red blood cell transfusion during the study is presented. RBC transfusions was given in case of medical need, i.e., in severely anemic participants with recognized symptoms or signs of anemia (e.g., in participants with acute blood loss, with severe angina, or whose Hb decreases to critical levels)
Time Frame
Up to Week 49
Title
Number of Participants With Any Adverse Events and Serious Adverse Events
Description
An adverse event (AE) was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment. A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Number of participants with at least one AE and SAE were reported.
Time Frame
Up to Week 49
Title
Mean Change From Baseline in Vital Signs: Systolic Blood Pressure and Diastolic Blood Pressure up to Week 24
Description
Change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) at Baseline and end of correction phase (Week 24) is presented. SBP and DBP were determined both before and after the dialysis session for participants. Baseline is defined as Day 1 visit. One participant from CERA group and two participants from Epoetin Beta group did not receive any study medication and were excluded from the safety analysis.
Time Frame
From Baseline (Day 1) to Week 24
Title
Mean Change From Baseline in Vital Sign: Heart Rate Measurements up to Week 24
Description
Heart rate was measured before blood sampling for all participants and before the dialysis session. Baseline is defined as Day 1. One participant from CERA group and two participants from Epoetin Beta group did not receive any study medication and were excluded from the safety analysis.
Time Frame
From Baseline (Day 1) to Week 24
Title
Number of Participants With Abnormal Changes in Electrocardiogram up to Week 24
Description
Twelve-lead ECG was recorded before or after the dialysis session. Number of participants with abnormal changes in electrocardiogram observed at any time point was reported. One participant from CERA group and two participants from Epoetin Beta group did not receive any study medication and were excluded from the safety analysis.
Time Frame
Up to Week 24
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;
maintenance hemodialysis or peritoneal dialysis for >=2 weeks before screening, and during screening period.
Exclusion Criteria:
previous therapy with epoetin within 8 weeks prior to screening;
overt gastrointestinal bleeding within 8 weeks before screening or during screening period;
RBC transfusions within 8 weeks before screening or during screening period;
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
Gyeonggi-do
ZIP/Postal Code
431-070
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
134-701
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
405-760
Country
Korea, Republic of
City
Sungnam
ZIP/Postal Code
463-802
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
24431909
Citation
Oh J, Joo KW, Chin HJ, Chae DW, Kim SG, Kim SJ, Chung W, Kim S, Huh W, Oh HY, Choi BS, Yang CW, Kim S. Correction of anemia with continuous erythropoietin receptor activator in Korean patients on long-term hemodialysis. J Korean Med Sci. 2014 Jan;29(1):76-83. doi: 10.3346/jkms.2014.29.1.76. Epub 2013 Dec 26.
Results Reference
derived
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A Study of Intravenous Mircera for the Correction of Anemia in Dialysis Patients.
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