Back to resultsA Study of Intravenous (iv) Mircera in Hemodialysis Patients With Chronic Renal Anemia
Primary Purpose
Anemia
Status
Completed
Phase
Phase 2
Locations
United States
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; on hemodialysis therapy for at least 3 months; receiving iv epoetin alfa during the 2 weeks prior to the run-in period. Exclusion Criteria: women who are pregnant, breastfeeding or using unreliable birth control methods; use of any investigational drug within 30 days of the run-in phase, or during the run-in or study treatment period.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Cohort 1 (RO0503821 [0.25/150 1x/week])
Cohort 2 (RO0503821 [0.25/150 1x/2week])
Cohort 3 (RO0503821 [0.4/150 1x/week])
Cohort 4 (RO0503821 [0.4/150 1x/2week])
Cohort 5 (RO0503821 [0.6/150 1x/week])
Cohort 6 (RO0503821 [0.6/150 1x/2week])
Arm Description
Eligible participant will be administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) intravenously (IV) using a dose conversion factor of 0.25/150 microgram (mcg)/kilogram (kg) of the previous weekly erythropoiesis stimulating agents (ESA) dose, (equal to 62.50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).
Eligible participant will be administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to 62.50% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).
Eligible participant will be administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).
Eligible participant will be administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).
Eligible participant will be administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).
Eligible participant will be administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).
Outcomes
Primary Outcome Measures
Median Change From Baseline in Hemoglobin Levels to End of Initial Treatment Under Constant Dosing Regimen
Median change from Baseline in hemoglobin (Hb) levels to end of initial treatment (EOIT) under constant dosing regimen was reported. For ease of interpretation, all individual slope values were multiplied by 42 to give an estimate of change in Hb values over six weeks. Baseline (Day -28 to Day 1) Hb values was calculated as the mean of the screening assessment (SA) and run-in period (Week -2 and Week -1). For all participants, an EOIT value was calculated as the last observed Hb value before a dose change or blood transfusion. For participants without any dose adjustments or blood transfusion, the EOIT value was identical to the Week 19 value.
Secondary Outcome Measures
Median Change From Baseline in Hematocrit Levels to End of Initial Treatment Under Constant Dosing Regimen
Median change from Baseline in hematocrit (Hct) levels to end of initial treatment under constant dosing regimen was reported. Baseline (Day -28 to Day 1) Hct values was calculated as the mean of the SA and run-in period (Weeks -2 and -1). For all participants, an EOIT value was calculated as the last observed Hct value before a dose change or blood transfusion. For participants without any dose adjustments or blood transfusion, the EOIT value was identical to the Week 19 value.
Number of Participants With Any Adverse Events, Any Serious Adverse Events, And Deaths
An Adverse Events (AEs) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Serious Adverse Events (SAEs) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes. ). The study design tested 3 different starting dose conversion factors at 3 different dosing schedules during the core study period. As study drug doses can be modified continually over time all results for the two long term safety periods were displayed by dose schedule group only.
Number of Participants With Marked Laboratory Abnormalities
Marked abnormality was defined as above and/or below a value which was considered to be potentially clinically relevant. The number of participants with marked lab abnormality across treatment groups were reported and presented. Marked laboratory abnormalities were analyzed according to the Roche specified limits for the following reference range: White blood cells (WBC) (3.0- 18.0 10^9/L), Platelets (100 - 550 10^9/L), Alanine aminotransferase (ALAT) [0 110 units per litre (U/L)], Alkaline Phosphatase (ALP) (0 - 220 U/L), Aspartate aminotransferase (ASAT) (0 - 80 U/L), Albumin >= 30 g/L, Phosphate [0.75 - 1.60 millimoles per liter (mmol/L)], Potassium (2.9 - 5.8 mmol/L), Glucose (2.80 - 11.10 mmol/L).
Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Before and After Dialysis
Mean Change from Baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) is calculated as the end of treatment values minus the Baseline value. Baseline (Day -28 to Day 1) values were calculated as the mean of the screening assessment (SA) and run-in period (Week -2 and Week -1).
Mean Change in Pulse Rate
Participants pulse rates in beats per minute (BpM) were analyzed at sitting position using descriptive statistical methods (ie, means, standard deviations and percentiles). The changes in pulse rate throughout the study were analysed at each study visit and mean change is reported.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00048035
Brief Title
A Study of Intravenous (iv) Mircera in Hemodialysis Patients With Chronic Renal Anemia
Official Title
An Open-label, Multicenter, Randomized Study to Determine Dose Conversion Factors at Different Frequencies of Administration After Switching From Maintenance Treatment With Intravenous Epoetin Alfa to Maintenance Treatment With Intravenous RO0503821 in Hemodialysis Patients With Chronic Renal Anemia.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
June 2005 (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 study will determine the appropriate dose and frequency of administration of iv Mircera maintenance therapy in hemodialysis patients with chronic renal anemia who were previously receiving iv epoetin. The anticipated time on study treatment is 3-12 months and the target sample size is <100 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 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
91 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1 (RO0503821 [0.25/150 1x/week])
Arm Type
Experimental
Arm Description
Eligible participant will be administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) intravenously (IV) using a dose conversion factor of 0.25/150 microgram (mcg)/kilogram (kg) of the previous weekly erythropoiesis stimulating agents (ESA) dose, (equal to 62.50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).
Arm Title
Cohort 2 (RO0503821 [0.25/150 1x/2week])
Arm Type
Experimental
Arm Description
Eligible participant will be administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to 62.50% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).
Arm Title
Cohort 3 (RO0503821 [0.4/150 1x/week])
Arm Type
Experimental
Arm Description
Eligible participant will be administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).
Arm Title
Cohort 4 (RO0503821 [0.4/150 1x/2week])
Arm Type
Experimental
Arm Description
Eligible participant will be administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).
Arm Title
Cohort 5 (RO0503821 [0.6/150 1x/week])
Arm Type
Experimental
Arm Description
Eligible participant will be administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).
Arm Title
Cohort 6 (RO0503821 [0.6/150 1x/2week])
Arm Type
Experimental
Arm Description
Eligible participant will be administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).
Intervention Type
Drug
Intervention Name(s)
methoxy polyethylene glycol-epoetin beta [Mircera]
Intervention Description
Differing doses and frequencies of iv administration
Primary Outcome Measure Information:
Title
Median Change From Baseline in Hemoglobin Levels to End of Initial Treatment Under Constant Dosing Regimen
Description
Median change from Baseline in hemoglobin (Hb) levels to end of initial treatment (EOIT) under constant dosing regimen was reported. For ease of interpretation, all individual slope values were multiplied by 42 to give an estimate of change in Hb values over six weeks. Baseline (Day -28 to Day 1) Hb values was calculated as the mean of the screening assessment (SA) and run-in period (Week -2 and Week -1). For all participants, an EOIT value was calculated as the last observed Hb value before a dose change or blood transfusion. For participants without any dose adjustments or blood transfusion, the EOIT value was identical to the Week 19 value.
Time Frame
From Baseline (Day -28 to Day 1) to EOIT (Week 19)
Secondary Outcome Measure Information:
Title
Median Change From Baseline in Hematocrit Levels to End of Initial Treatment Under Constant Dosing Regimen
Description
Median change from Baseline in hematocrit (Hct) levels to end of initial treatment under constant dosing regimen was reported. Baseline (Day -28 to Day 1) Hct values was calculated as the mean of the SA and run-in period (Weeks -2 and -1). For all participants, an EOIT value was calculated as the last observed Hct value before a dose change or blood transfusion. For participants without any dose adjustments or blood transfusion, the EOIT value was identical to the Week 19 value.
Time Frame
From Baseline (Day -28 to Day 1) to EOIT (Week 19)
Title
Number of Participants With Any Adverse Events, Any Serious Adverse Events, And Deaths
Description
An Adverse Events (AEs) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Serious Adverse Events (SAEs) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes. ). The study design tested 3 different starting dose conversion factors at 3 different dosing schedules during the core study period. As study drug doses can be modified continually over time all results for the two long term safety periods were displayed by dose schedule group only.
Time Frame
Up to Week 126
Title
Number of Participants With Marked Laboratory Abnormalities
Description
Marked abnormality was defined as above and/or below a value which was considered to be potentially clinically relevant. The number of participants with marked lab abnormality across treatment groups were reported and presented. Marked laboratory abnormalities were analyzed according to the Roche specified limits for the following reference range: White blood cells (WBC) (3.0- 18.0 10^9/L), Platelets (100 - 550 10^9/L), Alanine aminotransferase (ALAT) [0 110 units per litre (U/L)], Alkaline Phosphatase (ALP) (0 - 220 U/L), Aspartate aminotransferase (ASAT) (0 - 80 U/L), Albumin >= 30 g/L, Phosphate [0.75 - 1.60 millimoles per liter (mmol/L)], Potassium (2.9 - 5.8 mmol/L), Glucose (2.80 - 11.10 mmol/L).
Time Frame
Up to Week 126
Title
Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Before and After Dialysis
Description
Mean Change from Baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) is calculated as the end of treatment values minus the Baseline value. Baseline (Day -28 to Day 1) values were calculated as the mean of the screening assessment (SA) and run-in period (Week -2 and Week -1).
Time Frame
From Baseline (Day -28 to Day 1) to Week 126
Title
Mean Change in Pulse Rate
Description
Participants pulse rates in beats per minute (BpM) were analyzed at sitting position using descriptive statistical methods (ie, means, standard deviations and percentiles). The changes in pulse rate throughout the study were analysed at each study visit and mean change is reported.
Time Frame
Up to Week 126
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;
on hemodialysis therapy for at least 3 months;
receiving iv epoetin alfa during the 2 weeks prior to the run-in period.
Exclusion Criteria:
women who are pregnant, breastfeeding or using unreliable birth control methods;
use of any investigational drug within 30 days of the run-in phase, or during the run-in or study treatment period.
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
Birmingham
State/Province
Alabama
ZIP/Postal Code
35211
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202-1718
Country
United States
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202-2689
Country
United States
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
City
Brooklyn Center
State/Province
Minnesota
ZIP/Postal Code
55430
Country
United States
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
City
Paterson
State/Province
New Jersey
ZIP/Postal Code
07503
Country
United States
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10128
Country
United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of Intravenous (iv) Mircera in Hemodialysis Patients With Chronic Renal Anemia
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