Back to resultsA Study of Mircera for the Maintenance Treatment of Participants With Chronic Renal Anemia
Primary Purpose
Chronic Renal Anemia
Status
Completed
Phase
Phase 3
Locations
Greece
Study Type
Interventional
Intervention
Methoxy polyethylene glycol-epoetin beta
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Renal Anemia
Eligibility Criteria
Inclusion Criteria:
- Adults greater than or equal to (≥) 18 years of age
- Chronic renal anemia
- Stable epoetin alfa or darbepoetin alfa therapy for past 2 months
- Hemodialysis therapy for ≥3 months
Exclusion Criteria:
- Transfusion of red blood cells during previous 2 months
- Poorly controlled hypertension requiring hospitalization or interruption of ESA treatment in previous 6 months
- 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 who have been previously treated with erythropoiesis-stimulating agent (ESA) therapy will receive IV Mircera every 4 weeks for a total of 24 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg will be determined by the dose of ESA received prior to administration of study treatment. Subsequent doses will be adjusted to maintain Hb concentrations within target of 10.5 and 12.5 grams per deciliter (g/dL).
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 0). During the EEP (Weeks 17 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with Mircera/CERA. 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 10.5 to 12.5 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 0). During the EEP (Weeks 17 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with Mircera/CERA. 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 17 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 10.5 to 12.5 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 17 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with Mircera/CERA. Time spent in the target range of 10.5 to 12.5 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.
Percentage of Participants Who Required Any Dose Adjustment 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 17 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 Prematurely Withdrawn From the Study to Receive Blood Transfusion
The number of participants who were prematurely withdrawn from the study to receive a blood transfusion during treatment, including the DTP (Weeks 0 and 16) and/or EEP (Weeks 17 to 24), was reported.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00550680
Brief Title
A Study of Mircera for the Maintenance Treatment of 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 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
January 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 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 and safety of intravenous (IV) Mircera when administered for the maintenance of hemoglobin (Hb) levels in participants with chronic renal anemia. Individuals currently receiving maintenance treatment with epoetin alfa or darbepoetin alfa will receive monthly injections of Mircera, with the starting dose (120, 200, or 360 micrograms [mcg] IV injection) derived from the dose of epoetin alfa or darbepoetin alfa they were receiving 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
Chronic Renal 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
208 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mircera in Renal Anemia
Arm Type
Experimental
Arm Description
Participants with chronic renal anemia who have been previously treated with erythropoiesis-stimulating agent (ESA) therapy will receive IV Mircera every 4 weeks for a total of 24 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg will be determined by the dose of ESA received prior to administration of study treatment. Subsequent doses will be adjusted to maintain Hb concentrations within target of 10.5 and 12.5 grams per deciliter (g/dL).
Intervention Type
Drug
Intervention Name(s)
Methoxy polyethylene glycol-epoetin beta
Other Intervention Name(s)
Mircera/CERA
Intervention Description
Participants will receive a starting dose of 120, 200, or 360 mcg via IV injection. Thereafter, the once-monthly dose will be titrated to achieve target Hb concentrations.
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 0). During the EEP (Weeks 17 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with Mircera/CERA. 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 10.5 to 12.5 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, -1,and 0; 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 0). During the EEP (Weeks 17 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with Mircera/CERA. 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, -1, and 0; 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 17 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 10.5 to 12.5 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 17 to 24), participants provided a total of four blood samples for Hb monitoring while on treatment with Mircera/CERA. Time spent in the target range of 10.5 to 12.5 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
Percentage of Participants Who Required Any Dose Adjustment 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 17 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 Prematurely Withdrawn From the Study to Receive Blood Transfusion
Description
The number of participants who were prematurely withdrawn from the study to receive a blood transfusion during treatment, including the DTP (Weeks 0 and 16) and/or EEP (Weeks 17 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
Stable epoetin alfa or darbepoetin alfa therapy for past 2 months
Hemodialysis therapy for ≥3 months
Exclusion Criteria:
Transfusion of red blood cells during previous 2 months
Poorly controlled hypertension requiring hospitalization or interruption of ESA treatment in previous 6 months
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
Athens
ZIP/Postal Code
11362
Country
Greece
City
Athens
ZIP/Postal Code
11526
Country
Greece
City
Athens
ZIP/Postal Code
11527
Country
Greece
City
Athens
ZIP/Postal Code
11528
Country
Greece
City
Athens
ZIP/Postal Code
12462
Country
Greece
City
Athens
ZIP/Postal Code
18454
Country
Greece
City
Athens
ZIP/Postal Code
18536
Country
Greece
City
Corinthos
ZIP/Postal Code
20100
Country
Greece
City
Daphni-athens
ZIP/Postal Code
17237
Country
Greece
City
Egaleo
ZIP/Postal Code
12244
Country
Greece
City
Ioannina
ZIP/Postal Code
455 00
Country
Greece
City
Kalamata
ZIP/Postal Code
24100
Country
Greece
City
Kyparissia
ZIP/Postal Code
24500
Country
Greece
City
Lamia
ZIP/Postal Code
35100
Country
Greece
City
Larissa
ZIP/Postal Code
41 110
Country
Greece
City
Larissa
ZIP/Postal Code
41221
Country
Greece
City
Leivadia
ZIP/Postal Code
32100
Country
Greece
City
Mitilini
ZIP/Postal Code
81100
Country
Greece
City
Patra
ZIP/Postal Code
26225
Country
Greece
City
Rhodes
ZIP/Postal Code
85100
Country
Greece
City
Thessaloniki
ZIP/Postal Code
546 42
Country
Greece
City
Thessaloniki
ZIP/Postal Code
54629
Country
Greece
City
Thessaloniki
ZIP/Postal Code
57001
Country
Greece
City
Thessaloniki
ZIP/Postal Code
57010
Country
Greece
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
A Study of Mircera for the Maintenance Treatment of Participants With Chronic Renal Anemia
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