Back to resultsA Study of Once Monthly Subcutaneous Mircera in Patients With Chronic Renal Anemia Not on Dialysis
Primary Purpose
Anemia
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
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;
- continuous maintenance ESA therapy with the same dosing interval during the previous month, and no change in totally weekly dose.
Exclusion Criteria:
- transfusion of red blood cells during previous 2 months;
- poorly controlled hypertension;
- significant acute or chronic bleeding;
- active malignant disease (except non-melanoma skin cancer).
Sites / Locations
- Inje University Busan Paik Hospital; Nephrology
- Kyungpook National Uni Hospital; Internal Medicine
- Chungnam National Uni Hospital; Nephrology
- Chonnam National University Hospital
- NHIC Ilsan Hospital
- Seoul National Uni Hospital; Internal Medicine
- Seoul St Mary's Hospital
- Severance Hospital; Division of Nephrology
- East-West Neo Medical Center; Division Of Nephology
- Samsung Medical Centre; Department of Hematology & Oncology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Percentage of Participants Maintaining Average Hemoglobin Concentration Within the Target Range During the Efficacy Evaluable Period (EEP)
The target hemoglobin was defined as the mean of the three assessments recorded at Weeks -4, -2, and 0 (Stability Verification Period [SVP]). EEP was an 8 week period from Weeks 17 to 24. The 95 percent (%) confidence interval (CI) was estimated using Clopper-Pearson.
Secondary Outcome Measures
Change in Hemoglobin Concentration Between SVP and the EEP
Baseline hemoglobin was defined as the mean of the three assessments recorded at Weeks -4, -2, and 0 (SVP). EEP hemoglobin was defined as the mean of the hemoglobin assessments during EEP. EEP was an 8 week period from Weeks 17 to 24.
Percentage of Participants Maintaining Hemoglobin Concentration Within Hemoglobin Range 10.0 to 12.0 g/dL Throughout the EEP
EEP was an 8 week period from Weeks 17 to 24. The 95% CI was estimated using Clopper-Pearson.
Percentage of Participants Who Required Dose Adjustments During Dose Titration Period (DTP) and EEP
DTP was a 16- week period from Week 1 to Week 16, EEP was an 8-week period from Weeks 17 to 24. Dose adjustment was assessed during entire Week 1 to 24.
Time Spent in Hemoglobin Range of 10.0 to 12.0 g/dL During DTP and EEP
DTP was a 16- week period from Week 1 to Week 16, EEP was an 8-week period from Weeks 17 to 24. Dose adjustment was assessed during entire Week 1 to 24.
Average Dose of Mircera Per Month
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00922116
Brief Title
A Study of Once Monthly Subcutaneous Mircera in Patients With Chronic Renal Anemia Not on Dialysis
Official Title
A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Once-monthly Administration of Subcutaneous Mircera® for the Maintenance of Haemoglobin Levels in Patients With Chronic Renal Anaemia Who Are Not on Dialysis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
April 30, 2009 (Actual)
Primary Completion Date
November 30, 2010 (Actual)
Study Completion Date
November 30, 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This single arm study will assess the efficacy, safety and tolerability of once monthly administration of subcutaneous Mircera for the maintenance of hemoglobin levels in patients with chronic renal anemia not on dialysis.Patients will receive sc Mircera at a starting dose of 100, 120, 200 or 360 micrograms every 4 weeks, calculated from the last weekly dose of ESA previously administered. Subsequent doses will be adjusted to maintain hemoglobin levels within the target range. 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 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
191 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
methoxy polyethylene glycol-epoetin beta [Mircera]
Intervention Description
sc every month (starting dose of 100, 120, 150 or 200 micrograms based on previous ESA therapy)
Primary Outcome Measure Information:
Title
Percentage of Participants Maintaining Average Hemoglobin Concentration Within the Target Range During the Efficacy Evaluable Period (EEP)
Description
The target hemoglobin was defined as the mean of the three assessments recorded at Weeks -4, -2, and 0 (Stability Verification Period [SVP]). EEP was an 8 week period from Weeks 17 to 24. The 95 percent (%) confidence interval (CI) was estimated using Clopper-Pearson.
Time Frame
EEP (Weeks 17 to 24)
Secondary Outcome Measure Information:
Title
Change in Hemoglobin Concentration Between SVP and the EEP
Description
Baseline hemoglobin was defined as the mean of the three assessments recorded at Weeks -4, -2, and 0 (SVP). EEP hemoglobin was defined as the mean of the hemoglobin assessments during EEP. EEP was an 8 week period from Weeks 17 to 24.
Time Frame
SVP (Baseline), and EEP (Weeks 17 to 24)
Title
Percentage of Participants Maintaining Hemoglobin Concentration Within Hemoglobin Range 10.0 to 12.0 g/dL Throughout the EEP
Description
EEP was an 8 week period from Weeks 17 to 24. The 95% CI was estimated using Clopper-Pearson.
Time Frame
EEP (Weeks 17 to 24)
Title
Percentage of Participants Who Required Dose Adjustments During Dose Titration Period (DTP) and EEP
Description
DTP was a 16- week period from Week 1 to Week 16, EEP was an 8-week period from Weeks 17 to 24. Dose adjustment was assessed during entire Week 1 to 24.
Time Frame
Weeks 1 to 24
Title
Time Spent in Hemoglobin Range of 10.0 to 12.0 g/dL During DTP and EEP
Description
DTP was a 16- week period from Week 1 to Week 16, EEP was an 8-week period from Weeks 17 to 24. Dose adjustment was assessed during entire Week 1 to 24.
Time Frame
Weeks 1 to 24
Title
Average Dose of Mircera Per Month
Time Frame
Weeks 0-4, 4-8, 8-12, 12-16, 16-20, and 20-24
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;
continuous maintenance ESA therapy with the same dosing interval during the previous month, and no change in totally weekly dose.
Exclusion Criteria:
transfusion of red blood cells during previous 2 months;
poorly controlled hypertension;
significant acute or chronic 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:
Facility Name
Inje University Busan Paik Hospital; Nephrology
City
Busan
ZIP/Postal Code
633-165
Country
Korea, Republic of
Facility Name
Kyungpook National Uni Hospital; Internal Medicine
City
Daegu
ZIP/Postal Code
700-721
Country
Korea, Republic of
Facility Name
Chungnam National Uni Hospital; Nephrology
City
Daejeon
ZIP/Postal Code
301-721
Country
Korea, Republic of
Facility Name
Chonnam National University Hospital
City
Gwangju
ZIP/Postal Code
61469
Country
Korea, Republic of
Facility Name
NHIC Ilsan Hospital
City
Kyonggi-do
ZIP/Postal Code
411-719
Country
Korea, Republic of
Facility Name
Seoul National Uni Hospital; Internal Medicine
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Seoul St Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Severance Hospital; Division of Nephrology
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
East-West Neo Medical Center; Division Of Nephology
City
Seoul
ZIP/Postal Code
134-837
Country
Korea, Republic of
Facility Name
Samsung Medical Centre; Department of Hematology & Oncology
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
A Study of Once Monthly Subcutaneous Mircera in Patients With Chronic Renal Anemia Not on Dialysis
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