Back to resultsEfficacy, Safety and Tolerability Study of Subcutaneous C.E.R.A. in Pre-Dialysis Participants With Chronic Renal Anemia
Primary Purpose
Anemia
Status
Terminated
Phase
Phase 3
Locations
Sweden
Study Type
Interventional
Intervention
Methoxy polyethylene glycol-epoetin beta (C.E.R.A.)
Sponsored by
About this trial
This is an interventional treatment trial for Anemia
Eligibility Criteria
Inclusion Criteria:
- Chronic renal anemia
- Hemoglobin concentration between 10.5 gram per deciliter (g/dL) and 12.5 g/dL
- Adequate iron status (serum ferritin greater than [>] 100 nanogram per milliliter and Transferrin Saturation >20 percent [%] or hypochromic red cells less than [<] 10%)
- Continuous subcutaneous maintenance darbepoetin alfa therapy with same dosing interval during previous 2 months
Exclusion Criteria:
- Transfusion of red blood cells during previous 2 months
- Poorly controlled hypertension requiring hospitalization or interruption of darbepoetin alfa treatment in previous 6 months
- Acute or chronic bleeding
- Active malignant disease (except non-melanoma skin cancer)
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
C.E.R.A.
Arm Description
Outcomes
Primary Outcome Measures
Percentage of Participants Maintaining Mean Hemoglobin Concentration Within Plus or Minus (+/-) 1 Gram Per Deciliter (g/dL) of Their Reference Hemoglobin and Within the Target Range
Percentage of participants maintaining the mean hemoglobin concentration within +/- 1.0 g/dL of their reference hemoglobin value and within the target range of 10.5 to 12.5 g/dL during the efficacy evaluation period (EEP) was reported. The reference hemoglobin value was defined as the mean 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 to Week 24) was estimated as a time adjusted average.
Secondary Outcome Measures
Change in Hemoglobin Concentration Between Reference (SVP) and EEP
The reference hemoglobin value was defined as the mean of the 5 assessments recorded during the SVP at Weeks -4, -3, -2, -1 and 0. The mean change of the time adjusted average of hemoglobin from reference value obtained during the SVP (Week -4 up to Week 0) 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 10.5 to 12.5 g/dL during EEP (Week 17 to Week 24) was reported.
Mean Time Spent by Participants With Hemoglobin Concentration in the Target Range During the EEP
Mean time spent by participants with hemoglobin concentration within the target range of 10.5 to 12.5 g/dL during the EEP (Week 17 to Week 24) was reported.
Percentage of Participants Requiring Any Dose Adjustment
Percentage of participants requiring any 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.
Percentage of Participants With Red Blood Cell Transfusion During the Study
Percentage of participant who required red blood cell transfusion during the study was reported.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both serious as well as non-serious AEs.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00517881
Brief Title
Efficacy, Safety and Tolerability Study of Subcutaneous C.E.R.A. in Pre-Dialysis Participants With Chronic Renal Anemia
Official Title
A Single Arm Open Label Study to Assess the Efficacy, Safety and Tolerability of Once Monthly Administration of Subcutaneous C.E.R.A. for the Maintenance of Haemoglobin Levels in Pre-dialysis Patients With Chronic Renal Anaemia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated due to the slow recruitment rate.
Study Start Date
June 2007 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This single arm study will assess the efficacy, safety and tolerability of subcutaneous methoxy polyethylene glycol-epoetin beta (C.E.R.A.) for maintenance of hemoglobin levels in pre-dialysis participants with chronic renal anemia. Participants currently receiving maintenance treatment with subcutaneous darbepoetin alfa will receive monthly subcutaneous injections of C.E.R.A. with the starting dose of 120, 200 or 360 micrograms (mcg) derived from the dose of darbepoetin alfa or epoetin alfa in the week preceding study start.
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
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
C.E.R.A.
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Methoxy polyethylene glycol-epoetin beta (C.E.R.A.)
Other Intervention Name(s)
Mircera
Intervention Description
Subcutaneous methoxy polyethylene glycol-epoetin beta (C.E.R.A.) at starting dose of 120, 200, or 360 mcg every 4 weeks for 20 weeks. Further dose adjustments will be performed during the study depending on the participant's blood hemoglobin levels.
Primary Outcome Measure Information:
Title
Percentage of Participants Maintaining Mean Hemoglobin Concentration Within Plus or Minus (+/-) 1 Gram Per Deciliter (g/dL) of Their Reference Hemoglobin and Within the Target Range
Description
Percentage of participants maintaining the mean hemoglobin concentration within +/- 1.0 g/dL of their reference hemoglobin value and within the target range of 10.5 to 12.5 g/dL during the efficacy evaluation period (EEP) was reported. The reference hemoglobin value was defined as the mean 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 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 reference hemoglobin value was defined as the mean of the 5 assessments recorded during the SVP at Weeks -4, -3, -2, -1 and 0. The mean change of the time adjusted average of hemoglobin from reference value obtained during the SVP (Week -4 up to Week 0) and the value during EEP (Week 17 up to Week 24) was assessed.
Time Frame
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 10.5 to 12.5 g/dL during EEP (Week 17 to Week 24) was reported.
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 within the target range of 10.5 to 12.5 g/dL during the EEP (Week 17 to Week 24) was reported.
Time Frame
Week 17 up to Week 24
Title
Percentage of Participants Requiring Any Dose Adjustment
Description
Percentage of participants requiring any 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 up to Week 16 and Week 17 up to Week 24
Title
Percentage of Participants With Red Blood Cell Transfusion During the Study
Description
Percentage of participant who required red blood cell transfusion during the study was reported.
Time Frame
Week 0 up to Week 24
Title
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both serious as well as non-serious AEs.
Time Frame
Week 0 up to Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chronic renal anemia
Hemoglobin concentration between 10.5 gram per deciliter (g/dL) and 12.5 g/dL
Adequate iron status (serum ferritin greater than [>] 100 nanogram per milliliter and Transferrin Saturation >20 percent [%] or hypochromic red cells less than [<] 10%)
Continuous subcutaneous maintenance darbepoetin alfa therapy with same dosing interval during previous 2 months
Exclusion Criteria:
Transfusion of red blood cells during previous 2 months
Poorly controlled hypertension requiring hospitalization or interruption of darbepoetin alfa treatment in previous 6 months
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:
City
Danderyd
ZIP/Postal Code
18288
Country
Sweden
City
Eksjo
ZIP/Postal Code
57581
Country
Sweden
City
Eskilstuna
ZIP/Postal Code
63188
Country
Sweden
City
Gaevle
ZIP/Postal Code
80187
Country
Sweden
City
Goeteborg
ZIP/Postal Code
41345
Country
Sweden
City
Gothenburg
ZIP/Postal Code
S-402 76
Country
Sweden
City
Huddinge
ZIP/Postal Code
14186
Country
Sweden
City
Jonkoping
ZIP/Postal Code
55185
Country
Sweden
City
Kristianstad
ZIP/Postal Code
29185
Country
Sweden
City
Skellefteå
ZIP/Postal Code
S-931 86
Country
Sweden
City
Stockholm
ZIP/Postal Code
17176
Country
Sweden
City
Umea
ZIP/Postal Code
90185
Country
Sweden
City
Värnamo
ZIP/Postal Code
33185
Country
Sweden
City
Västervik
ZIP/Postal Code
59381
Country
Sweden
12. IPD Sharing Statement
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Efficacy, Safety and Tolerability Study of Subcutaneous C.E.R.A. in Pre-Dialysis Participants With Chronic Renal Anemia
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