Back to resultsA Study of Intravenous Mircera in Participants With Chronic Renal Anemia Who Are on Dialysis
Primary Purpose
Anemia
Status
Completed
Phase
Phase 3
Locations
Hungary
Study Type
Interventional
Intervention
Methoxy polyethylene glycol-epoetin beta
Sponsored by
About this trial
This is an interventional treatment trial for Anemia
Eligibility Criteria
Inclusion Criteria:
- Adults greater than or equal to (≥) 18 years of age
- Chronic renal anemia
- Continuous stable intravenous or subcutaneous maintenance epoetin or darbepoetin therapy during previous month
- Regular long-term hemodialysis therapy with the same mode of dialysis for the previous 3 months
Exclusion Criteria:
- Transfusion of red blood cells during previous 2 months
- Poorly controlled hypertension
- Significant acute or chronic bleeding
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Mircera in Renal Anemia
Arm Description
Participants with chronic renal anemia previously treated with ESA therapy will receive intravenous Mircera, also known as continuous erythropoietin receptor activator (CERA), every 4 weeks for a total of 52 weeks in this single-arm study. The first dose will be determined by the dose of ESA received prior to administration of study treatment, and subsequent doses will be adjusted to achieve target Hb concentrations.
Outcomes
Primary Outcome Measures
Percentage of Participants Who Maintained Average Hb Within Plus/Minus (±) 1 g/dL of Reference Hb and Within Target Range During the Efficacy Evaluation Period (EEP)
Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment stability assessment (Weeks -4 to -1). During the EEP (Weeks 18 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with CERA/Mircera. The average Hb during the EEP was calculated per participant and assessed against the reference value. The percentage of participants who had average Hb during the EEP in the target range of 10.0 to 12.0 g/dL and within ±1 g/dL of their individual reference Hb was determined as the primary endpoint. The 95 percent (%) confidence interval (CI) was calculated using the Pearson-Clopper method for exact confidence bounds.
Secondary Outcome Measures
Mean Change in Time-Adjusted Hb From Baseline to EEP
Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment stability assessment (Weeks -4 to -1). During the EEP (Weeks 18 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with CERA/Mircera. The average Hb during the EEP was calculated per participant and assessed against the reference value. The mean change in Hb value between reference (i.e., "Baseline") Hb and the EEP average Hb was calculated and expressed in g/dL.
Percentage of Participants Whose Hb Remained Within Target Range Throughout the EEP
During the EEP (Weeks 18 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with CERA/Mircera. The percentage of participants who maintained each single Hb measurement in the target range of 10.0 to 12.0 g/dL was determined. The 95% CI was calculated using the Pearson-Clopper method for exact confidence bounds.
Mean Time Spent in the Target Range for Hb During the EEP
During the EEP (Weeks 18 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with CERA/Mircera. Time spent in the target range of 10.0 to 12.0 g/dL was defined as time from first on-target Hb to time of last known on-target Hb, as collected during the EEP. Time spent in the target range was averaged among all participants and expressed in days.
Mean Dose of Mircera/CERA During the Dose Titration Period (DTP) and EEP
Study drug administration occurred monthly during the DTP (Weeks 0 to 16), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during Week -1. Subsequent doses could be adjusted throughout the study including during the EEP (Weeks 18 to 24) on the basis of Hb levels or other modification criteria. The dose received at each administration visit was averaged among all participants during the DTP and EEP and expressed in mcg.
Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA During the DTP and EEP
Study drug administration occurred monthly during the DTP (Weeks 0 to 16), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during Week -1. Subsequent doses could be adjusted throughout the study including during the EEP (Weeks 18 to 24) on the basis of Hb levels or other modification criteria. The percentage of participants who required a dose adjustment for any reason was calculated during the DTP and EEP.
Number of Participants Receiving Blood Transfusion During the DTP and EEP
The number of participants who received blood transfusion during the DTP (Weeks 0 and 16) and EEP (Weeks 18 to 24) was reported.
Number of Blood Transfusions During the DTP and EEP
The number of blood transfusion during the DTP (Weeks 0 and 16) and EEP (Weeks 18 to 24) was reported.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00660023
Brief Title
A Study of Intravenous Mircera in Participants With Chronic Renal Anemia Who Are on Dialysis
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
February 2016
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (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 and safety of monthly administration of intravenous methoxy polyethylene glycol-epoetin beta (CERA/Mircera) for the maintenance of hemoglobin (Hb) levels in participants on dialysis with chronic renal anemia in routine clinical practice in Hungary. Participants currently receiving maintenance treatment with intravenous epoetin or darbepoetin will receive monthly injections of Mircera, with the starting dose derived from the erythropoiesis-stimulating agent (ESA) dose they had been receiving.
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
124 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mircera in Renal Anemia
Arm Type
Experimental
Arm Description
Participants with chronic renal anemia previously treated with ESA therapy will receive intravenous Mircera, also known as continuous erythropoietin receptor activator (CERA), every 4 weeks for a total of 52 weeks in this single-arm study. The first dose will be determined by the dose of ESA received prior to administration of study treatment, and subsequent doses will be adjusted to achieve target Hb concentrations.
Intervention Type
Drug
Intervention Name(s)
Methoxy polyethylene glycol-epoetin beta
Other Intervention Name(s)
CERA/Mircera
Intervention Description
Participants will receive intravenous CERA/Mircera every month, with starting dose based on previous ESA therapy. Treatment will continue for 52 weeks.
Primary Outcome Measure Information:
Title
Percentage of Participants Who Maintained Average Hb Within Plus/Minus (±) 1 g/dL of Reference Hb and Within Target Range During the Efficacy Evaluation Period (EEP)
Description
Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment stability assessment (Weeks -4 to -1). During the EEP (Weeks 18 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with CERA/Mircera. The average Hb during the EEP was calculated per participant and assessed against the reference value. The percentage of participants who had average Hb during the EEP in the target range of 10.0 to 12.0 g/dL and within ±1 g/dL of their individual reference Hb was determined as the primary endpoint. The 95 percent (%) confidence interval (CI) was calculated using the Pearson-Clopper method for exact confidence bounds.
Time Frame
Weeks -4, -3, -2, and -1; pre-dose (0 hours) during Weeks 18, 20, 22, and 24
Secondary Outcome Measure Information:
Title
Mean Change in Time-Adjusted Hb From Baseline to EEP
Description
Reference Hb was determined individually per participant as the average of all Hb values during a pre-treatment stability assessment (Weeks -4 to -1). During the EEP (Weeks 18 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with CERA/Mircera. The average Hb during the EEP was calculated per participant and assessed against the reference value. The mean change in Hb value between reference (i.e., "Baseline") Hb and the EEP average Hb was calculated and expressed in g/dL.
Time Frame
At Weeks -4, -3, -2, and -1; pre-dose (0 hours) during Weeks 18, 20, 22, and 24
Title
Percentage of Participants Whose Hb Remained Within Target Range Throughout the EEP
Description
During the EEP (Weeks 18 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with CERA/Mircera. The percentage of participants who maintained each single Hb measurement in the target range of 10.0 to 12.0 g/dL was determined. The 95% CI was calculated using the Pearson-Clopper method for exact confidence bounds.
Time Frame
Pre-dose (0 hours) during Weeks 18, 20, 22, and 24
Title
Mean Time Spent in the Target Range for Hb During the EEP
Description
During the EEP (Weeks 18 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with CERA/Mircera. Time spent in the target range of 10.0 to 12.0 g/dL was defined as time from first on-target Hb to time of last known on-target Hb, as collected during the EEP. Time spent in the target range was averaged among all participants and expressed in days.
Time Frame
Pre-dose (0 hours) during Weeks 18, 20, 22, and 24
Title
Mean Dose of Mircera/CERA During the Dose Titration Period (DTP) and EEP
Description
Study drug administration occurred monthly during the DTP (Weeks 0 to 16), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during Week -1. Subsequent doses could be adjusted throughout the study including during the EEP (Weeks 18 to 24) on the basis of Hb levels or other modification criteria. The dose received at each administration visit was averaged among all participants during the DTP and EEP and expressed in mcg.
Time Frame
Weeks 0, 4, 8, 12, 16, 20, and 24
Title
Percentage of Participants Who Required Any Dose Adjustment of Mircera/CERA During the DTP and EEP
Description
Study drug administration occurred monthly during the DTP (Weeks 0 to 16), which began with a pre-specified dose of Mircera/CERA according to the dose of ESA administered during Week -1. Subsequent doses could be adjusted throughout the study including during the EEP (Weeks 18 to 24) on the basis of Hb levels or other modification criteria. The percentage of participants who required a dose adjustment for any reason was calculated during the DTP and EEP.
Time Frame
Weeks 0, 4, 8, 12, 16, 20, and 24
Title
Number of Participants Receiving Blood Transfusion During the DTP and EEP
Description
The number of participants who received blood transfusion during the DTP (Weeks 0 and 16) and EEP (Weeks 18 to 24) was reported.
Time Frame
Continuously and at every visit from Week 0 (every week until Week 2, thereafter every 2 weeks) through Week 24
Title
Number of Blood Transfusions During the DTP and EEP
Description
The number of blood transfusion during the DTP (Weeks 0 and 16) and EEP (Weeks 18 to 24) was reported.
Time Frame
Continuously and at every visit from Week 0 (every week until Week 2, thereafter every 2 weeks) through Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults greater than or equal to (≥) 18 years of age
Chronic renal anemia
Continuous stable intravenous or subcutaneous maintenance epoetin or darbepoetin therapy during previous month
Regular long-term hemodialysis therapy with the same mode of dialysis for the previous 3 months
Exclusion Criteria:
Transfusion of red blood cells during previous 2 months
Poorly controlled hypertension
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
Baja
ZIP/Postal Code
6500
Country
Hungary
City
Budapest
ZIP/Postal Code
1062
Country
Hungary
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
City
Esztergom
ZIP/Postal Code
2500
Country
Hungary
City
Keszthely
ZIP/Postal Code
8360
Country
Hungary
City
Miskolc
ZIP/Postal Code
3526
Country
Hungary
City
Salgótarján
ZIP/Postal Code
3100
Country
Hungary
City
Szolnok
ZIP/Postal Code
5000
Country
Hungary
City
VAC
ZIP/Postal Code
2600
Country
Hungary
City
Zalaegerszeg
ZIP/Postal Code
8900
Country
Hungary
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
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A Study of Intravenous Mircera in Participants With Chronic Renal Anemia Who Are on Dialysis
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