Back to resultsA Study of Intravenous Mircera in Dialysis Patients With Chronic Renal Disease and Anemia.
Primary Purpose
Anemia
Status
Completed
Phase
Phase 3
Locations
Russian Federation
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;
- hemodialysis or peritoneal dialysis, with same mode of dialysis for >=3 months before and throughout screening period;
- continuous maintenance epoetin alfa or beta therapy with the same dosing interval during the previous 2 months.
Exclusion Criteria:
- transfusion of red blood cells during previous 2 months;
- poorly controlled hypertension requiring interruption of epoetin alfa or beta treatment in past 6 months;
- significant acute or chronic bleeding such as overt gastrointestinal bleeding;
- hemolysis;
- folic acid and vitamin B12 deficiency.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
RO0503821 (C.E.R.A.), 1x/4weeks
Arm Description
Eligible participants started RO0503821 (Continuous Erythropoietin Receptor Activator [C.E.R.A]) intravenously, at a dose of 120, 200 or 360 microgram (µg) every four weeks. The dose of C.E.R.A was based on the epoetin alfa or beta dose of<8000, 8000-16000, or >16000 international units (IU)/week, administered during the stability verification period (SVP) of 4 weeks. The SVP period was followed by dose titration period (DTP) of 16 weeks, efficacy evaluation period (EEP) of 8 weeks and long term safety period (LTSP) of 28 weeks
Outcomes
Primary Outcome Measures
Percentage of Participants Maintaining Average Hemoglobin Concentration Within +\- 1 Gram/Deciliter of Their Reference Hb and Between 10.5 and 12.5 Gram/Deciliter During EEP
All mean Hb values recorded during the evaluation period were calculated and subtracted from the mean baseline Hb value for each participant. The percentage of participants maintaining their mean Hemoglobin (Hb) concentration within +/- 1 gram/deciliter (g/dL) of their reference Hb and between 10.5 -12.5 g/dL is presented during the EEP. The EEP is defined as Week 16 to Week 24
Secondary Outcome Measures
Mean Change in Hb Concentration From Baseline to the EEP
A time adjusted mean change in Hb concentration was calculated using an area under the curve approach, for both periods separately. Change in Hb concentration between the baseline and evaluation periods was calculated by subtracting the calculated average baseline Hb value from the average evaluation period Hb value. All blood samples for Hb measurements were taken prior to study drug administration. Analysis used last observation carried forward (LOCF) for missing Hb values to correct for the impact of early dropouts. The baseline period is defined as Week -4 to Week -1. The EEP is defined as Week 16 to Week 24
Percentage of Participants Maintaining Average Hb Concentration Within Target Range of 10.5-12.5 g/dL Throughout the EEP
All mean Hb values recorded during the EEP were calculated. The percentage of participants maintaining their average Hb concentration within the targeted range 10.5-12.5 g/dL during the EEP were reported. The EEP is defined as Week 16 to Week 24
Mean Number of Days Spent Within Hb Range of 10.5-12.5 g/dL During the EEP
The mean number of days the participant spent within the Hb range 10.5-12.5 g/dL during the EEP was reported. The EEP is defined as Week 16 to Week 24
Number of Participants Requiring Any Dose Adjustment During the DTP, EEP, and LTSP
The number of participants who required dose adjustments of C.E.R.A were categorized as; 1. No dose change; 2. Any dose change: a. Dose increase only; b. Dose decrease only; c. Dose increase and increase; 3. Only one dose, all of which were recorded during DTP, EEP and LTSP. DTP is defined as Week 1 to Week 16, EEP is defined as Week 16 to Week 24 and LTSP is defined as Week 24 to Week 44
Number of Participants With Red Blood Cell Transfusion
The number of participants who underwent red blood cell transfusion was reported
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00576303
Brief Title
A Study of Intravenous Mircera in Dialysis Patients With Chronic Renal Disease and Anemia.
Official Title
A Single-arm, Open Label Multicenter Study to Assess the Efficacy, Safety and Tolerability of Once Monthly Administration of C.E.R.A. for the Maintenance of Hemoglobin Levels in Dialysis Patients With Chronic Renal Anemia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 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, safety and tolerability of monthly intravenous Mircera for the maintenance of hemoglobin levels in dialysis patients with chronic renal disease, currently receiving epoetin alfa or beta. Patients will receive monthly intravenous injections of Mircera at a starting dose of 120, 200 or 360 micrograms/month, depending on the dose of epoetin alfa or beta they were receiving in the week preceding study start. 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
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RO0503821 (C.E.R.A.), 1x/4weeks
Arm Type
Experimental
Arm Description
Eligible participants started RO0503821 (Continuous Erythropoietin Receptor Activator [C.E.R.A]) intravenously, at a dose of 120, 200 or 360 microgram (µg) every four weeks. The dose of C.E.R.A was based on the epoetin alfa or beta dose of<8000, 8000-16000, or >16000 international units (IU)/week, administered during the stability verification period (SVP) of 4 weeks. The SVP period was followed by dose titration period (DTP) of 16 weeks, efficacy evaluation period (EEP) of 8 weeks and long term safety period (LTSP) of 28 weeks
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/Deciliter of Their Reference Hb and Between 10.5 and 12.5 Gram/Deciliter During EEP
Description
All mean Hb values recorded during the evaluation period were calculated and subtracted from the mean baseline Hb value for each participant. The percentage of participants maintaining their mean Hemoglobin (Hb) concentration within +/- 1 gram/deciliter (g/dL) of their reference Hb and between 10.5 -12.5 g/dL is presented during the EEP. The EEP is defined as Week 16 to Week 24
Time Frame
EEP (Week 16 to Week 24)
Secondary Outcome Measure Information:
Title
Mean Change in Hb Concentration From Baseline to the EEP
Description
A time adjusted mean change in Hb concentration was calculated using an area under the curve approach, for both periods separately. Change in Hb concentration between the baseline and evaluation periods was calculated by subtracting the calculated average baseline Hb value from the average evaluation period Hb value. All blood samples for Hb measurements were taken prior to study drug administration. Analysis used last observation carried forward (LOCF) for missing Hb values to correct for the impact of early dropouts. The baseline period is defined as Week -4 to Week -1. The EEP is defined as Week 16 to Week 24
Time Frame
Baseline (Week -4 to Week -1), EEP (Week 16 to Week 24)
Title
Percentage of Participants Maintaining Average Hb Concentration Within Target Range of 10.5-12.5 g/dL Throughout the EEP
Description
All mean Hb values recorded during the EEP were calculated. The percentage of participants maintaining their average Hb concentration within the targeted range 10.5-12.5 g/dL during the EEP were reported. The EEP is defined as Week 16 to Week 24
Time Frame
EEP (Week 16 to Week 24)
Title
Mean Number of Days Spent Within Hb Range of 10.5-12.5 g/dL During the EEP
Description
The mean number of days the participant spent within the Hb range 10.5-12.5 g/dL during the EEP was reported. The EEP is defined as Week 16 to Week 24
Time Frame
EEP (Week 16 to Week 24)
Title
Number of Participants Requiring Any Dose Adjustment During the DTP, EEP, and LTSP
Description
The number of participants who required dose adjustments of C.E.R.A were categorized as; 1. No dose change; 2. Any dose change: a. Dose increase only; b. Dose decrease only; c. Dose increase and increase; 3. Only one dose, all of which were recorded during DTP, EEP and LTSP. DTP is defined as Week 1 to Week 16, EEP is defined as Week 16 to Week 24 and LTSP is defined as Week 24 to Week 44
Time Frame
DTP (Week 1 to Week 16), EEP (Week 16 to Week 24) and LTSP (Week 24 to Week 44)
Title
Number of Participants With Red Blood Cell Transfusion
Description
The number of participants who underwent red blood cell transfusion was reported
Time Frame
Up to 3 years
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;
hemodialysis or peritoneal dialysis, with same mode of dialysis for >=3 months before and throughout screening period;
continuous maintenance epoetin alfa or beta therapy with the same dosing interval during the previous 2 months.
Exclusion Criteria:
transfusion of red blood cells during previous 2 months;
poorly controlled hypertension requiring interruption of epoetin alfa or beta treatment in past 6 months;
significant acute or chronic bleeding such as overt gastrointestinal bleeding;
hemolysis;
folic acid and vitamin B12 deficiency.
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
Ekaterinburg
ZIP/Postal Code
620102
Country
Russian Federation
City
Kemerovo
ZIP/Postal Code
650066
Country
Russian Federation
City
Krasnodar
ZIP/Postal Code
350086
Country
Russian Federation
City
Moscow
ZIP/Postal Code
117049
Country
Russian Federation
City
Moscow
ZIP/Postal Code
123182
Country
Russian Federation
City
Moscow
ZIP/Postal Code
125101
Country
Russian Federation
City
Moscow
ZIP/Postal Code
127006
Country
Russian Federation
City
Moscow
ZIP/Postal Code
129110
Country
Russian Federation
City
Moscow
ZIP/Postal Code
129317
Country
Russian Federation
City
Novosibirsk
ZIP/Postal Code
630087
Country
Russian Federation
City
Omsk
ZIP/Postal Code
644111
Country
Russian Federation
City
St Petersburg
ZIP/Postal Code
191015
Country
Russian Federation
City
St Petersburg
ZIP/Postal Code
195067
Country
Russian Federation
City
St Petersburg
ZIP/Postal Code
196247
Country
Russian Federation
City
St Petersburg
ZIP/Postal Code
197089
Country
Russian Federation
City
St Petersburg
ZIP/Postal Code
197110
Country
Russian Federation
City
St-Petersburg
ZIP/Postal Code
198510
Country
Russian Federation
City
Volzhsky
ZIP/Postal Code
404130
Country
Russian Federation
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 Intravenous Mircera in Dialysis Patients With Chronic Renal Disease and Anemia.
We'll reach out to this number within 24 hrs