Back to resultsSTABIL Study: National Study With Mircera for Maintenance of Hemoglobin Level in Dialysis Patients
Primary Purpose
Anemia
Status
Completed
Phase
Phase 3
Locations
Czech Republic
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:
- Chronic renal anemia;
- Continuous stable intravenous maintenance epoetin therapy during previous month;
- Regular long-term hemodialysis therapy with the same mode of dialysis for previous 3 months.
Exclusion Criteria:
- Transfusion of red blood cells during previous 2 months;
- Poorly controlled hypertension, that is, sitting blood pressure exceeding 170/100 millimeter of mercury (mmHg) despite medication;
- Significant acute or chronic bleeding.
Sites / Locations
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 +/-1 Gram Per Deciliter (g/dL) of Reference and Within the Target Range
Percentage of participants maintaining their mean hemoglobin concentration in g/dL within plus or minus (+/-) 1 g/dL of their reference hemoglobin value, and between the target range of 10.0 and 12.0 g/dL during the efficacy evaluation period (EEP). The reference hemoglobin value was defined on the basis of the 5 assessments recorded during the Stability Verification Period (SVP) at Weeks -4, -3, -2, -1 and 0. The mean hemoglobin concentration for each individual participant during the EEP (Week 17 up to Week 24) was estimated as a time adjusted average.
Secondary Outcome Measures
Change in Hemoglobin Concentration Between Reference (SVP) and EEP
The mean change of the time adjusted average of hemoglobin from reference value obtained during the SVP (Week -4 up to Week -1) and the value during EEP (Week 17 up to Week 24) was assessed.
Percentage of Participants Maintaining Hemoglobin Concentration Within the Target Range During EEP
Percentage of participants maintaining hemoglobin concentration within the target range of 10.0 to 12.0 g/dL during EEP (Week 17 to Week 24) was assessed.
Mean Time Spent by Participants With Hemoglobin Concentration in the Target Range During the EEP
Mean time spent by participants with hemoglobin concentration in the target range of 10.0 to 12.0 g/dL during the EEP (Week 17 to Week 24) was assessed.
Percentage of Participants Requiring Any Dose Adjustment
Percentage of participants requiring adjustment in the dose of study drug during the dose titration period (DTP: Week 1 to Week 16) and EEP (Week 17 to Week 24) was reported.
Number of Participants With Red Blood Cell Transfusion During the Study
Number of participant who underwent red blood cell transfusion during the study was reported.
Number of Participants With Anti-epoetin Antibody
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00642850
Brief Title
STABIL Study: National Study With Mircera for Maintenance of Hemoglobin Level in Dialysis Patients
Official Title
A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Once-monthly Administration of Intravenous C.E.R.A. for the Maintenance of Haemoglobin Levels in Dialysis Patients With Chronic Renal Anaemia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 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 single arm study will assess the efficacy, safety and tolerability of once-monthly administration of intravenous Mircera for the maintenance of hemoglobin levels in dialysis participants with chronic renal anemia. Participants will receive monthly intravenous injections of Mircera, at a starting dose of 120, 200 or 360 micrograms, according to the dose of epoetin administered in the week preceding first study drug administration. 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
N/A
Enrollment
188 (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
120, 200 or 360 micrograms iv monthly (starting dose)
Primary Outcome Measure Information:
Title
Percentage of Participants Maintaining Average Hemoglobin Concentration Within +/-1 Gram Per Deciliter (g/dL) of Reference and Within the Target Range
Description
Percentage of participants maintaining their mean hemoglobin concentration in g/dL within plus or minus (+/-) 1 g/dL of their reference hemoglobin value, and between the target range of 10.0 and 12.0 g/dL during the efficacy evaluation period (EEP). The reference hemoglobin value was defined on the basis of the 5 assessments recorded during the Stability Verification Period (SVP) at Weeks -4, -3, -2, -1 and 0. The mean hemoglobin concentration for each individual participant during the EEP (Week 17 up to Week 24) was estimated as a time adjusted average.
Time Frame
Week 17 up to Week 24
Secondary Outcome Measure Information:
Title
Change in Hemoglobin Concentration Between Reference (SVP) and EEP
Description
The mean change of the time adjusted average of hemoglobin from reference value obtained during the SVP (Week -4 up to Week -1) and the value during EEP (Week 17 up to Week 24) was assessed.
Time Frame
Week -4 up to Week -1 and Week 17 up to Week 24
Title
Percentage of Participants Maintaining Hemoglobin Concentration Within the Target Range During EEP
Description
Percentage of participants maintaining hemoglobin concentration within the target range of 10.0 to 12.0 g/dL during EEP (Week 17 to Week 24) was assessed.
Time Frame
Week 17 up to Week 24
Title
Mean Time Spent by Participants With Hemoglobin Concentration in the Target Range During the EEP
Description
Mean time spent by participants with hemoglobin concentration in the target range of 10.0 to 12.0 g/dL during the EEP (Week 17 to Week 24) was assessed.
Time Frame
Week 17 up to Week 24
Title
Percentage of Participants Requiring Any Dose Adjustment
Description
Percentage of participants requiring adjustment in the dose of study drug during the dose titration period (DTP: Week 1 to Week 16) and EEP (Week 17 to Week 24) was reported.
Time Frame
Week 1 to Week 16 and Week 17 to Week 24
Title
Number of Participants With Red Blood Cell Transfusion During the Study
Description
Number of participant who underwent red blood cell transfusion during the study was reported.
Time Frame
Week -4 up to Week 28
Title
Number of Participants With Anti-epoetin Antibody
Time Frame
Week -4 and at early withdrawal or Week 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chronic renal anemia;
Continuous stable intravenous maintenance epoetin therapy during previous month;
Regular long-term hemodialysis therapy with the same mode of dialysis for previous 3 months.
Exclusion Criteria:
Transfusion of red blood cells during previous 2 months;
Poorly controlled hypertension, that is, sitting blood pressure exceeding 170/100 millimeter of mercury (mmHg) despite medication;
Significant acute or chronic bleeding.
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
Brno
ZIP/Postal Code
656 91
Country
Czech Republic
City
Cesky Krumlov
ZIP/Postal Code
38127
Country
Czech Republic
City
Decin
ZIP/Postal Code
405 99
Country
Czech Republic
City
Havirov
ZIP/Postal Code
736 24
Country
Czech Republic
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czech Republic
City
Jihlava
ZIP/Postal Code
586 33
Country
Czech Republic
City
Karlovy Vary
ZIP/Postal Code
360 73
Country
Czech Republic
City
Kolin Iii
ZIP/Postal Code
280 20
Country
Czech Republic
City
Liberec
ZIP/Postal Code
460 63
Country
Czech Republic
City
Novy Jicin
ZIP/Postal Code
741 11
Country
Czech Republic
City
Olomouc
ZIP/Postal Code
775 20
Country
Czech Republic
City
Ostrava
ZIP/Postal Code
708 52
Country
Czech Republic
City
Pisek
ZIP/Postal Code
397 23
Country
Czech Republic
City
Praha 6
ZIP/Postal Code
169 00
Country
Czech Republic
City
Praha
ZIP/Postal Code
128 08
Country
Czech Republic
City
Praha
ZIP/Postal Code
14000
Country
Czech Republic
City
Praha
ZIP/Postal Code
150 30
Country
Czech Republic
City
Strakonice
ZIP/Postal Code
38629
Country
Czech Republic
City
Sumperk
ZIP/Postal Code
787 01
Country
Czech Republic
City
Tabor
ZIP/Postal Code
390 03
Country
Czech Republic
City
Teplice
ZIP/Postal Code
415 01
Country
Czech Republic
City
Trebic
ZIP/Postal Code
674 01
Country
Czech Republic
City
Usti Nad Labem
ZIP/Postal Code
401 13
Country
Czech Republic
City
Znojmo
ZIP/Postal Code
76275
Country
Czech Republic
12. IPD Sharing Statement
Citations:
PubMed Identifier
26965694
Citation
Locatelli F, Choukroun G, Truman M, Wiggenhauser A, Fliser D. Once-Monthly Continuous Erythropoietin Receptor Activator (C.E.R.A.) in Patients with Hemodialysis-Dependent Chronic Kidney Disease: Pooled Data from Phase III Trials. Adv Ther. 2016 Apr;33(4):610-25. doi: 10.1007/s12325-016-0309-6. Epub 2016 Mar 10.
Results Reference
derived
Learn more about this trial
STABIL Study: National Study With Mircera for Maintenance of Hemoglobin Level in Dialysis Patients
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