Trial Outcomes & Findings for A Study of Two-Weekly Intravenous Mircera for the Treatment of Dialysis Patients With Chronic Renal Anemia Not Receiving ESA Therapy. (NCT NCT00737711)
NCT ID: NCT00737711
Last Updated: 2016-06-02
Results Overview
The difference between the mean Hemoglobin (Hb) value at the last visit (Week 16) of the treatment period (TP) and at Baseline (Week 0) is presented. TP was from Baseline to Week 16.
COMPLETED
PHASE4
189 participants
Baseline (Week 0) and Week 16
2016-06-02
Participant Flow
The study was conducted from 08 July 2008 to 31 May 2009 across 16 centers in India. A total of 189 participants were enrolled in the study.
Participant milestones
| Measure |
MIRCERA
Participants with chronic renal anemia, on dialysis, received 0.6 microgram per kilogram of body weight (mcg/kg) of Methoxy polyethylene glycol-epoetin beta (MIRCERA/RO0503821), intravenously once every two weeks for 16 weeks. A telephonic / physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
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|---|---|
|
Overall Study
STARTED
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189
|
|
Overall Study
COMPLETED
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158
|
|
Overall Study
NOT COMPLETED
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31
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Reasons for withdrawal
| Measure |
MIRCERA
Participants with chronic renal anemia, on dialysis, received 0.6 microgram per kilogram of body weight (mcg/kg) of Methoxy polyethylene glycol-epoetin beta (MIRCERA/RO0503821), intravenously once every two weeks for 16 weeks. A telephonic / physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
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|---|---|
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Overall Study
Adverse Event
|
2
|
|
Overall Study
Death
|
8
|
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Overall Study
Failure to return
|
4
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Withdrawal by Subject
|
5
|
|
Overall Study
Blood transfusion
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6
|
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Overall Study
Other
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5
|
Baseline Characteristics
A Study of Two-Weekly Intravenous Mircera for the Treatment of Dialysis Patients With Chronic Renal Anemia Not Receiving ESA Therapy.
Baseline characteristics by cohort
| Measure |
MIRCERA
n=189 Participants
Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
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|---|---|
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Age, Continuous
|
49.74 years
STANDARD_DEVIATION 14.01 • n=5 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
139 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Baseline (Week 0) and Week 16Population: The intent-to-treat (ITT) population included all participants who received at least one dose of the study drug. Data for participants available at the time of assessment is presented.
The difference between the mean Hemoglobin (Hb) value at the last visit (Week 16) of the treatment period (TP) and at Baseline (Week 0) is presented. TP was from Baseline to Week 16.
Outcome measures
| Measure |
MIRCERA
n=159 Participants
Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
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|---|---|
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Mean Change in Hemoglobin Concentration From Baseline to Week 16 of the Treatment Period
|
2.11 gram/deciliter (g/dL)
Standard Deviation 1.30
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SECONDARY outcome
Timeframe: Up to Week 16Population: The ITT population included all participants who received at least one dose of the study drug. Data for participants available at the time of assessment is presented.
Achievement of blood Hb levels within target range of 10.0-12.0 g/dL was considered as achievement of response. The mean time required to achieve the Hb target range is presented in weeks.
Outcome measures
| Measure |
MIRCERA
n=144 Participants
Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
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|---|---|
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Mean Time Required to Achieve Blood Hemoglobin Levels Within Target Range of 10.0-12.0 Gram/Deciliter
|
6.10 Weeks
Standard Deviation 3.87
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SECONDARY outcome
Timeframe: Week 12 to Week 16Population: The ITT population included all participants who received at least one dose of the study drug. Data for participants available at the time of assessment is presented.
The Hb concentration was recorded for all the participants at enrollment and different time points throughout the study up to Week 16. The mean time spent (in weeks) by the participants in the target range (10-12 g/dL) during the last 4 weeks of the TP is presented.
Outcome measures
| Measure |
MIRCERA
n=103 Participants
Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
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|---|---|
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Mean Time Spent in the Hemoglobin Range of 10.0-12.0 Gram/Deciliter From Week 12 to Week 16
|
3.07 Weeks
Standard Deviation 1.00
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SECONDARY outcome
Timeframe: Week 12 to Week 16Population: The ITT population included all participants who received at least one dose of the study drug.
The Hb concentration was recorded for all the participants at enrollment and different time points throughout the study up to Week 16. The percentage of participants achieving Hb levels within target range of 10.0-12.0 g/dL during the last 4 weeks of the TP is presented.
Outcome measures
| Measure |
MIRCERA
n=189 Participants
Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
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|---|---|
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Percentage of Participants With Average Hemoglobin Concentration Between 10.0-12.0 Gram/Deciliter From Week 12 to Week 16
|
46.20 percentage of participants
Interval 38.56 to 53.97
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SECONDARY outcome
Timeframe: Up to Week 18Population: Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number.
An adverse event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. A serious adverse event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution. An SAE is any AE that can result in death or is life-threatening or required participant hospitalization or prolongation of existing hospitalization or results in persistent or significant disability/incapacity; or is a congenital anomaly/birth defect; or is medically significant or requires intervention to prevent one or other of the outcomes listed above
Outcome measures
| Measure |
MIRCERA
n=189 Participants
Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
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|---|---|
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Number of Participants With Adverse Events, Serious Adverse Events and Deaths
Participants with any AE
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53 Participants
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Number of Participants With Adverse Events, Serious Adverse Events and Deaths
Participants with SAE
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24 Participants
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Number of Participants With Adverse Events, Serious Adverse Events and Deaths
Deaths
|
8 Participants
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SECONDARY outcome
Timeframe: Up to Week 16Population: Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.
Twelve-lead electrocardiogram (ECG) was recorded for the participants. The number of participants with abnormal ECG is presented.
Outcome measures
| Measure |
MIRCERA
n=189 Participants
Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
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|---|---|
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Number of Participants With Abnormal Electrocardiogram
Participants with abnormal ECG, Week 0, n=189
|
52 Participants
|
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Number of Participants With Abnormal Electrocardiogram
Participants with abnormal ECG, Week 16, n=164
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49 Participants
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SECONDARY outcome
Timeframe: Up to Week 16Population: The ITT population included all participants who receive at least one dose of study drug. Participants available at the time of assessment were included.
Indications for blood transfusions were acute blood loss (bleeding), lack of treatment response or treatment failure, or other reasons.
Outcome measures
| Measure |
MIRCERA
n=189 Participants
Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
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|---|---|
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Number of Participants With Reports of Blood Transfusions
White blood cells transfusions
|
1 Participants
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Number of Participants With Reports of Blood Transfusions
Pack cell transfusions
|
6 Participants
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|
Number of Participants With Reports of Blood Transfusions
Pure red cell transfusions
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0 Participants
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SECONDARY outcome
Timeframe: Up to Week 16Population: The ITT population included all participants who receive at least one dose of study drug.
Participants were assessed for the presence of Anti-Epoetin antibodies for MIRCERA.
Outcome measures
| Measure |
MIRCERA
n=189 Participants
Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
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|---|---|
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Number of Participants With Reports of Anti-Epoetin Antibodies
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0 Participants
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SECONDARY outcome
Timeframe: Baseline (Week 0), Week 4, Week 10, and Week 16Population: Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.
The mean values of white blood cells are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Outcome measures
| Measure |
MIRCERA
n=187 Participants
Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
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|---|---|
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Mean White Blood Cell Count Over Time
Week 0, n = 187
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9382.89 cells per cubic millimeter
Standard Deviation 11644.69
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Mean White Blood Cell Count Over Time
Week 4, n = 173
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9181.27 cells per cubic millimeter
Standard Deviation 12689.96
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Mean White Blood Cell Count Over Time
Week 10, n = 167
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9361.38 cells per cubic millimeter
Standard Deviation 13319.73
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Mean White Blood Cell Count Over Time
Week 16, n = 159
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9023.71 cells per cubic millimeter
Standard Deviation 13109.61
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SECONDARY outcome
Timeframe: Baseline (Week 0), Week 4, Week 10, and Week 16Population: Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.
Mean corpuscular volume (MCV) is a measure of the average volume of red blood corpuscles (RBCs) and is calculated by dividing hematocrit value by the concentration of RBCs. Mean values of MCV are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. Reference range of mean corpuscular volume is 80-96 femtoliter (fL) per red blood cell.
Outcome measures
| Measure |
MIRCERA
n=183 Participants
Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
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|---|---|
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Mean Value of Mean Corpuscular Volume Over Time
Week 0, n = 183
|
87.05 Femtoliter
Standard Deviation 11.37
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|
Mean Value of Mean Corpuscular Volume Over Time
Week 4, n = 169
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89.17 Femtoliter
Standard Deviation 6.99
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|
Mean Value of Mean Corpuscular Volume Over Time
Week 10, n = 167
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88.46 Femtoliter
Standard Deviation 6.85
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|
Mean Value of Mean Corpuscular Volume Over Time
Week 16, n = 159
|
88.03 Femtoliter
Standard Deviation 9.36
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SECONDARY outcome
Timeframe: Baseline (Week 0), Week 4, Week 10, and Week 16Population: Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.
Mean values of hypochromic RBCs are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Outcome measures
| Measure |
MIRCERA
n=39 Participants
Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
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|---|---|
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Mean Hypochromic Red Blood Cells Over Time
Week 0, n = 39
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3.84 cells per cubic millimeter
Standard Deviation 5.78
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Mean Hypochromic Red Blood Cells Over Time
Week 4, n = 39
|
2.74 cells per cubic millimeter
Standard Deviation 1.13
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Mean Hypochromic Red Blood Cells Over Time
Week 10, n = 36
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3.23 cells per cubic millimeter
Standard Deviation 1.27
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Mean Hypochromic Red Blood Cells Over Time
Week 16, n = 31
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3.52 cells per cubic millimeter
Standard Deviation 1.50
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SECONDARY outcome
Timeframe: Baseline (Week 0), Week 4, Week 10, and Week 16Population: Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.
Mean values of platelet count are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Outcome measures
| Measure |
MIRCERA
n=186 Participants
Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
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|---|---|
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Mean Platelet Count Over Time
Week 0, n = 186
|
214629.03 cells per cubic millimeter
Standard Deviation 77442.90
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Mean Platelet Count Over Time
Week 4, n = 177
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203050.85 cells per cubic millimeter
Standard Deviation 81720.79
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Mean Platelet Count Over Time
Week 10, n = 167
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204922.16 cells per cubic millimeter
Standard Deviation 78064.46
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Mean Platelet Count Over Time
Week 16, n = 158
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194550.63 cells per cubic millimeter
Standard Deviation 78937.74
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SECONDARY outcome
Timeframe: Baseline (Week 0), Week 4, Week 10, and Week 16Population: Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.
Mean values of serum iron are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Outcome measures
| Measure |
MIRCERA
n=187 Participants
Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
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|---|---|
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Mean Serum Iron Over Time
Week 0, n = 187
|
91.72 microgram/deciliter (mcg/dL)
Standard Deviation 53.44
|
|
Mean Serum Iron Over Time
Week 4, n = 171
|
80.17 microgram/deciliter (mcg/dL)
Standard Deviation 39.45
|
|
Mean Serum Iron Over Time
Week 10, n = 166
|
87.62 microgram/deciliter (mcg/dL)
Standard Deviation 42.90
|
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Mean Serum Iron Over Time
Week 16, n = 157
|
91.70 microgram/deciliter (mcg/dL)
Standard Deviation 47.36
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SECONDARY outcome
Timeframe: Baseline (Week 0), Week 4, Week 10, and Week 16Population: Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.
Mean values of serum ferritin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Outcome measures
| Measure |
MIRCERA
n=188 Participants
Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
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|---|---|
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Mean Serum Ferritin Over Time
Week 0, n = 188
|
963.28 nanogram /milliliter (ng/mL)
Standard Deviation 2398.89
|
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Mean Serum Ferritin Over Time
Week 4, n = 170
|
702.37 nanogram /milliliter (ng/mL)
Standard Deviation 679.50
|
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Mean Serum Ferritin Over Time
Week 10, n = 161
|
686.42 nanogram /milliliter (ng/mL)
Standard Deviation 723.22
|
|
Mean Serum Ferritin Over Time
Week 16, n = 153
|
641.26 nanogram /milliliter (ng/mL)
Standard Deviation 627.66
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 4, Week 10, and Week 16Population: Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.
Mean values of serum transferrin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Outcome measures
| Measure |
MIRCERA
n=73 Participants
Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
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|---|---|
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Mean Transferrin Over Time
Week 0, n = 73
|
173.48 milligram per deciliter (mg/dL)
Standard Deviation 108.93
|
|
Mean Transferrin Over Time
Week 4, n = 66
|
176.97 milligram per deciliter (mg/dL)
Standard Deviation 105.16
|
|
Mean Transferrin Over Time
Week 10, n = 55
|
237.98 milligram per deciliter (mg/dL)
Standard Deviation 304.97
|
|
Mean Transferrin Over Time
Week 16, n = 58
|
181.50 milligram per deciliter (mg/dL)
Standard Deviation 174.83
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 4, Week 10, and Week 16Population: Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.
Mean values of total iron-binding capacity are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Outcome measures
| Measure |
MIRCERA
n=185 Participants
Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
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|---|---|
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Mean Total Iron-binding Capacity Over Time
Week 0, n = 185
|
247.06 mcg/dL
Standard Deviation 64.08
|
|
Mean Total Iron-binding Capacity Over Time
Week 4, n = 166
|
243.25 mcg/dL
Standard Deviation 71.20
|
|
Mean Total Iron-binding Capacity Over Time
Week 10, n = 160
|
245.30 mcg/dL
Standard Deviation 69.25
|
|
Mean Total Iron-binding Capacity Over Time
Week 16, n = 153
|
245.30 mcg/dL
Standard Deviation 70.03
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 4, Week 10, and Week 16Population: Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.
Transferrin saturation (TSAT) measured as a percentage, is a medical laboratory test. It is calculated as serum iron/ total iron-binding capacity x 100. Mean values of transferrin saturation at Baseline (Week 0), Week 4, Week 10, and Week 16 are presented.
Outcome measures
| Measure |
MIRCERA
n=186 Participants
Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
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|---|---|
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Mean Transferrin Saturation Over Time
Week 0, n = 186
|
40.39 Percentage of transferrin saturation
Standard Deviation 27.87
|
|
Mean Transferrin Saturation Over Time
Week 4, n=168
|
35.31 Percentage of transferrin saturation
Standard Deviation 22.46
|
|
Mean Transferrin Saturation Over Time
Week 10, n=161
|
36.91 Percentage of transferrin saturation
Standard Deviation 18.85
|
|
Mean Transferrin Saturation Over Time
Week 16, n = 153
|
38.31 Percentage of transferrin saturation
Standard Deviation 21.27
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 4, Week 10, and Week 16Population: Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.
Mean values of serum albumin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Outcome measures
| Measure |
MIRCERA
n=185 Participants
Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
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|---|---|
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Mean Serum Albumin Over Time
Week 10, n = 167
|
3.57 g/dL
Standard Deviation 0.57
|
|
Mean Serum Albumin Over Time
Week 16, n = 155
|
3.61 g/dL
Standard Deviation 0.54
|
|
Mean Serum Albumin Over Time
Week 0, n = 185
|
3.51 g/dL
Standard Deviation 0.54
|
|
Mean Serum Albumin Over Time
Week 4, n = 172
|
3.48 g/dL
Standard Deviation 0.53
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 4, Week 10, and Week 16Population: Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.
Mean values of serum globulin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Outcome measures
| Measure |
MIRCERA
n=179 Participants
Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
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|---|---|
|
Mean Serum Globulin Over Time
Week 0, n = 179
|
3.36 g/dL
Standard Deviation 0.67
|
|
Mean Serum Globulin Over Time
Week 4, n = 163
|
3.24 g/dL
Standard Deviation 0.63
|
|
Mean Serum Globulin Over Time
Week 10, n = 159
|
3.33 g/dL
Standard Deviation 0.63
|
|
Mean Serum Globulin Over Time
Week 16, n = 150
|
3.50 g/dL
Standard Deviation 2.50
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 4, Week 10, and Week 16Population: Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.
Mean values of serum creatinine are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Outcome measures
| Measure |
MIRCERA
n=186 Participants
Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
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|---|---|
|
Mean Serum Creatinine Over Time
Week 0, n = 186
|
8.25 mg/dL
Standard Deviation 3.05
|
|
Mean Serum Creatinine Over Time
Week 4, n = 171
|
8.65 mg/dL
Standard Deviation 3.09
|
|
Mean Serum Creatinine Over Time
Week 10, n = 168
|
9.48 mg/dL
Standard Deviation 7.69
|
|
Mean Serum Creatinine Over Time
Week 16, n = 158
|
9.05 mg/dL
Standard Deviation 3.31
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 4, Week 10, and Week 16Population: Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.
Mean values of blood urea nitrogen (BUN) are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Outcome measures
| Measure |
MIRCERA
n=181 Participants
Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
|
|---|---|
|
Mean Blood Urea Nitrogen Over Time
Week 0, n = 181
|
68.98 mg/dL
Standard Deviation 48.61
|
|
Mean Blood Urea Nitrogen Over Time
Week 4, n = 170
|
66.19 mg/dL
Standard Deviation 42.13
|
|
Mean Blood Urea Nitrogen Over Time
Week 10, n = 168
|
67.21 mg/dL
Standard Deviation 42.29
|
|
Mean Blood Urea Nitrogen Over Time
Week 16, n = 157
|
69.88 mg/dL
Standard Deviation 47.77
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 4, Week 10, and Week 16Population: Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.
Mean values of serum potassium are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Outcome measures
| Measure |
MIRCERA
n=183 Participants
Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
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|---|---|
|
Mean Serum Potassium Over Time
Week 0, n = 183
|
5.76 millimoles per liter (mmol/L)
Standard Deviation 9.28
|
|
Mean Serum Potassium Over Time
Week 4, n = 168
|
5.23 millimoles per liter (mmol/L)
Standard Deviation 0.97
|
|
Mean Serum Potassium Over Time
Week 10, n = 168
|
7.53 millimoles per liter (mmol/L)
Standard Deviation 16.82
|
|
Mean Serum Potassium Over Time
Week 16, n = 157
|
8.30 millimoles per liter (mmol/L)
Standard Deviation 37.90
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 4, Week 10, and Week 16Population: Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.
Mean values of serum sodium are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Outcome measures
| Measure |
MIRCERA
n=184 Participants
Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
|
|---|---|
|
Mean Serum Sodium Over Time
Week 0, n = 184
|
136.4 mmol/L
Standard Deviation 10.67
|
|
Mean Serum Sodium Over Time
Week 4, n = 168
|
136.3 mmol/L
Standard Deviation 11.32
|
|
Mean Serum Sodium Over Time
Week 10, n = 168
|
133.9 mmol/L
Standard Deviation 20.98
|
|
Mean Serum Sodium Over Time
Week 16, n = 156
|
137.0 mmol/L
Standard Deviation 11.19
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 4, Week 10, and Week 16Population: Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.
Mean values of serum phosphate are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Outcome measures
| Measure |
MIRCERA
n=166 Participants
Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
|
|---|---|
|
Mean Serum Phosphate Over Time
Week 0, n = 166
|
6.20 mg/dL
Standard Deviation 7.50
|
|
Mean Serum Phosphate Over Time
Week 4, n = 156
|
6.32 mg/dL
Standard Deviation 7.58
|
|
Mean Serum Phosphate Over Time
Week 10, n = 155
|
8.71 mg/dL
Standard Deviation 34.13
|
|
Mean Serum Phosphate Over Time
Week 16, n = 146
|
6.17 mg/dL
Standard Deviation 2.16
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 4, Week 10, and Week 16Population: Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.
Mean values of serum bilirubin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Outcome measures
| Measure |
MIRCERA
n=142 Participants
Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
|
|---|---|
|
Mean Serum Bilirubin Over Time
Week 0, n = 142
|
0.58 mg/dL
Standard Deviation 0.32
|
|
Mean Serum Bilirubin Over Time
Week 4, n = 124
|
0.68 mg/dL
Standard Deviation 0.86
|
|
Mean Serum Bilirubin Over Time
Week 10, n = 123
|
0.70 mg/dL
Standard Deviation 1.08
|
|
Mean Serum Bilirubin Over Time
Week 16, n = 117
|
0.62 mg/dL
Standard Deviation 0.50
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 4, Week 10, and Week 16Population: Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.
Mean values of aspartate transaminase are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Outcome measures
| Measure |
MIRCERA
n=184 Participants
Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
|
|---|---|
|
Mean Aspartate Transaminase Over Time
Week 0, n = 184
|
22.33 Units/Liter (U/L)
Standard Deviation 13.06
|
|
Mean Aspartate Transaminase Over Time
Week 4, n = 171
|
21.69 Units/Liter (U/L)
Standard Deviation 14.93
|
|
Mean Aspartate Transaminase Over Time
Week 10, n = 166
|
24.61 Units/Liter (U/L)
Standard Deviation 19.44
|
|
Mean Aspartate Transaminase Over Time
Week 16, n = 157
|
22.63 Units/Liter (U/L)
Standard Deviation 18.53
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 4, Week 10, and Week 16Population: Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.
Mean values of alanine aminotransferase are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Outcome measures
| Measure |
MIRCERA
n=185 Participants
Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
|
|---|---|
|
Mean Alanine Aminotransferase Over Time
Week 0, n = 185
|
27.89 U/L
Standard Deviation 19.38
|
|
Mean Alanine Aminotransferase Over Time
Week 4, n = 171
|
26.80 U/L
Standard Deviation 21.57
|
|
Mean Alanine Aminotransferase Over Time
Week 10, n = 166
|
28.11 U/L
Standard Deviation 25.02
|
|
Mean Alanine Aminotransferase Over Time
Week 16, n = 157
|
29.21 U/L
Standard Deviation 24.45
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 4, Week 10, and Week 16Population: Safety population included all participants who receive at least one dose of study drug, and for whom all safety parameters were listed in individual participant listings, by visit, center and participant number. n = the number of participants analyzed at a given time point.
Mean values of serum alkaline phosphatase are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Outcome measures
| Measure |
MIRCERA
n=175 Participants
Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
|
|---|---|
|
Mean Serum Alkaline Phosphatase Over Time
Week 4, n = 159
|
161.7 U/L
Standard Deviation 197.8
|
|
Mean Serum Alkaline Phosphatase Over Time
Week 10, n = 156
|
161.7 U/L
Standard Deviation 172.7
|
|
Mean Serum Alkaline Phosphatase Over Time
Week 16, n = 145
|
153.5 U/L
Standard Deviation 135.2
|
|
Mean Serum Alkaline Phosphatase Over Time
Week 0, n = 175
|
176.2 U/L
Standard Deviation 208.4
|
Adverse Events
MIRCERA
Serious adverse events
| Measure |
MIRCERA
n=189 participants at risk
Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
|
|---|---|
|
Cardiac disorders
Cardio-respiratory arrest
|
2.1%
4/189 • Up to Week 18
Safety population included all participants who receive at least one dose of study drug.
|
|
Cardiac disorders
Pericardial effusion
|
0.53%
1/189 • Up to Week 18
Safety population included all participants who receive at least one dose of study drug.
|
|
Gastrointestinal disorders
Haematemesis
|
0.53%
1/189 • Up to Week 18
Safety population included all participants who receive at least one dose of study drug.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.53%
1/189 • Up to Week 18
Safety population included all participants who receive at least one dose of study drug.
|
|
General disorders
Death
|
1.6%
3/189 • Up to Week 18
Safety population included all participants who receive at least one dose of study drug.
|
|
General disorders
Pyrexia
|
2.1%
4/189 • Up to Week 18
Safety population included all participants who receive at least one dose of study drug.
|
|
Infections and infestations
Cellulitis
|
0.53%
1/189 • Up to Week 18
Safety population included all participants who receive at least one dose of study drug.
|
|
Infections and infestations
Lower respiratory tract infection
|
1.1%
2/189 • Up to Week 18
Safety population included all participants who receive at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
1.1%
2/189 • Up to Week 18
Safety population included all participants who receive at least one dose of study drug.
|
|
Infections and infestations
Sepsis
|
0.53%
1/189 • Up to Week 18
Safety population included all participants who receive at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Diabetic foot
|
0.53%
1/189 • Up to Week 18
Safety population included all participants who receive at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.53%
1/189 • Up to Week 18
Safety population included all participants who receive at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.53%
1/189 • Up to Week 18
Safety population included all participants who receive at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
1.1%
2/189 • Up to Week 18
Safety population included all participants who receive at least one dose of study drug.
|
|
Surgical and medical procedures
Amputation
|
0.53%
1/189 • Up to Week 18
Safety population included all participants who receive at least one dose of study drug.
|
|
Surgical and medical procedures
Arteriovenous fistula operation
|
1.1%
2/189 • Up to Week 18
Safety population included all participants who receive at least one dose of study drug.
|
|
Vascular disorders
Accelerated hypertension
|
0.53%
1/189 • Up to Week 18
Safety population included all participants who receive at least one dose of study drug.
|
|
Vascular disorders
Hypotension
|
1.1%
2/189 • Up to Week 18
Safety population included all participants who receive at least one dose of study drug.
|
Other adverse events
| Measure |
MIRCERA
n=189 participants at risk
Participants with chronic renal anemia, on dialysis, received 0.6 mcg/kg MIRCERA, intravenously once every two weeks for 16 weeks. A telephonic or physical follow-up visit took place 2 weeks after the end of the MIRCERA treatment period.
|
|---|---|
|
General disorders
Pyrexia
|
5.8%
11/189 • Up to Week 18
Safety population included all participants who receive at least one dose of study drug.
|
Additional Information
Roche Trial Information Hotline
F. Hoffmann-La Roche AG
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER