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An Observational Study of Mircera (Methoxy Polyethylene Glycol-epoetin Beta) in Patients With Renal Anemia

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ClinicalTrials.gov Identifier: NCT01051323
Recruitment Status : Completed
First Posted : January 18, 2010
Results First Posted : December 18, 2015
Last Update Posted : December 18, 2015
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Anemia
Intervention Drug: methoxy polyethylene glycol-ep [Mircera]
Enrollment 1580
Recruitment Details  
Pre-assignment Details Data of this non-interventional study were analyzed by the following strata: predialysis participants versus hemodialysis participants, unless otherwise specified.
Arm/Group Title Methoxy Polyethylene Glycol-epoetin Beta (All Participants)
Hide Arm/Group Description Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
Period Title: Overall Study
Started 1580
Received at Least One Dose 1547
Completed 1041
Not Completed 539
Reason Not Completed
Discontinuation of treatment             103
Transplantation             28
Dialysis dependency             22
Withdrawal by Subject             13
Lost to Follow-up             31
Death             129
Hospitalization             28
Other             148
Missing             37
Arm/Group Title Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis) Total
Hide Arm/Group Description Predialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary. Hemodialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary. Total of all reporting groups
Overall Number of Baseline Participants 326 1184 1510
Hide Baseline Analysis Population Description
Full Analysis Set (FAS): all participants for whom at least one hemoglobin value after the first application of methoxy polyethylene glycol-epoetin beta during the study course was documented.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 326 participants 1184 participants 1510 participants
71.8  (13.3) 68.0  (13.8) 68.8  (13.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 326 participants 1184 participants 1510 participants
Female
158
  48.5%
479
  40.5%
637
  42.2%
Male
168
  51.5%
705
  59.5%
873
  57.8%
1.Primary Outcome
Title Percentage of Participants With at Least One Hemoglobin Value Outside the Target Range
Hide Description Mean hemoglobin was calculated from measurements taken during the Evaluation Period (Month 0 to Month 12). The target hemoglobin range was 10 to 13 gram/deciliter (g/dL). Percentage of participants with at least one hemoglobin value less than (<) 10 g/dL or greater than (>) 13 g/dL during the evaluation period by predialysis/hemodialysis is presented.
Time Frame Month 0 to Month 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis)
Hide Arm/Group Description:
Predialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
Hemodialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
Overall Number of Participants Analyzed 326 1184
Measure Type: Number
Unit of Measure: percentage of participants
Hemoglobin value <10 g/dL 97.9 72.9
Hemoglobin value >13 g/dL 33.7 35.3
2.Primary Outcome
Title Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size
Hide Description The percentage of participants with hemoglobin (Hb) values within the pre-defined ranges (10–12 g/dL, 11–12 g/dL, and 11–13 g/dL) during evaluation period (Month 0 to Month 12) by dose modification (yes or no), age (<65 years, greater than or equal to [>=] 65 years) and center size (>100 participants, less than or equal to [<=] 100 participants) is presented.
Time Frame Month 0 to Month 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS. n = participants evaluable for specified category for each arm group, respectively.
Arm/Group Title Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis)
Hide Arm/Group Description:
Predialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
Hemodialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
Overall Number of Participants Analyzed 326 1184
Measure Type: Number
Unit of Measure: percentage of participants
No dose modifications: Hb 10-12 g/dL (n=157, 242) 11.5 8.7
No dose modifications: Hb 11-12 g/dL (n=157, 242) 0.6 0.8
No dose modifications: Hb 11-13 g/dL (n=157, 242) 11.5 11.2
With dose modifications: Hb 10-12g/dL (n=169, 942) 6.5 4.9
With dose modifications: Hb 11-12g/dL (n=169, 942) 0.6 0.1
With dose modifications: Hb 11-13g/dL (n=169, 942) 8.9 5.2
Age <65 years: Hb 10-12 g/dL (n=70, 402) 10.0 6.7
Age <65 years: Hb 11-12 g/dL (n=70, 402) 1.4 0.5
Age <65 years: Hb 11-13 g/dL (n=70, 402) 8.6 8.8
Age >=65 years: Hb 10-12 g/dL (n=256, 782) 8.6 5.1
Age >=65 years: Hb 11-12 g/dL (n=256, 782) 0.4 0.1
Age >=65 years: Hb 11-13 g/dL (n=256, 782) 10.5 5.4
Center size >100: Hb 10-12 g/dL (n=99, 563) 17.2 6.0
Center size >100: Hb 11-12 g/dL (n=99, 563) 2.0 0.4
Center size >100: Hb 11-13 g/dL (n=99, 563) 13.1 7.5
Center size <=100: Hb 10-12 g/dL (n=227, 621) 5.3 5.3
Center size <=100: Hb 11-12 g/dL (n=227, 621) 0 0.2
Center size <=100: Hb 11-13 g/dL (n=227, 621) 8.8 5.5
3.Primary Outcome
Title Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size
Hide Description The percentage of participants with hemoglobin values within the pre-defined ranges (10-12 g/dL, 11-12 g/dL, and 11-13 g/dL) during Month 6 to Month 12 by dose modification (yes or no), age (<65 years, >=65 years) and center size (>100 participants, <=100 participants) is presented.
Time Frame Month 6 to Month 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS. n = participants evaluable for specified category for each arm group, respectively.
Arm/Group Title Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis)
Hide Arm/Group Description:
Predialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
Hemodialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
Overall Number of Participants Analyzed 326 1184
Measure Type: Number
Unit of Measure: percentage of participants
No dose modifications: Hb 10-12 g/dL (n=157, 242) 9.6 12.8
No dose modifications: Hb 11-12 g/dL (n=157, 242) 3.2 2.5
No dose modifications: Hb 11-13 g/dL (n=157, 242) 8.3 12.8
With dose modifications: Hb 10-12g/dL (n=169, 942) 10.7 14.6
With dose modifications: Hb 11-12g/dL (n=169, 942) 1.2 2.3
With dose modifications: Hb 11-13g/dL (n=169, 942) 9.5 15.1
Age <65 years: Hb 10-12 g/dL (n=70, 402) 11.4 14.7
Age <65 years: Hb 11-12 g/dL (n=70, 402) 4.3 3.0
Age <65 years: Hb 11-13 g/dL (n=70, 402) 12.9 18.4
Age >=65 years: Hb 10-12 g/dL (n=256, 782) 9.8 14.1
Age >=65 years: Hb 11-12 g/dL (n=256, 782) 1.6 2.0
Age >=65 years: Hb 11-13 g/dL (n=256, 782) 7.8 12.7
Center size >100: Hb 10-12 g/dL (n=99, 563) 20.2 14.9
Center size >100: Hb 11-12 g/dL (n=99, 563) 7.1 3.4
Center size >100: Hb 11-13 g/dL (n=99, 563) 15.2 15.1
Center size <=100: Hb 10-12 g/dL (n=227, 621) 5.7 13.7
Center size <=100: Hb 11-12 g/dL (n=227, 621) 0 1.4
Center size <=100: Hb 11-13 g/dL (n=227, 621) 6.2 14.2
4.Primary Outcome
Title Maximum Intra-Individual Fluctuation of Hemoglobin Values by Predialysis/Hemodialysis, Age, and Center Size
Hide Description For characterization of intra-individual fluctuations, the maximum absolute differences were derived from study period specific individual mean values. Maximum intra-individual fluctuation of hemoglobin values by predialysis/hemodialysis, age (<65 years, >=65 years), and center size (>100 participants, <=100 participants) is presented. Data for this outcome measure was reported for overall participants.
Time Frame Month 0 to Month 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS. N (number of participants analyzed) = participants evaluable for this measure. n = participants evaluable for specified category.
Arm/Group Title Methoxy Polyethylene Glycol-epoetin Beta (All Participants)
Hide Arm/Group Description:
Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
Overall Number of Participants Analyzed 1489
Mean (Standard Deviation)
Unit of Measure: g/dL
Predialysis (n=317) 1.3  (0.8)
Hemodialysis (n=1172) 1.6  (0.8)
Age <65 years (n=467) 1.6  (0.8)
Age >=65 years (n=1022) 1.5  (0.8)
Center size >100 participants (n=654) 1.5  (0.8)
Center size <=100 participants (n=835) 1.6  (0.8)
5.Primary Outcome
Title Serum Ferritin Values
Hide Description Serum ferritin levels were measured as nanogram/milliliter (ng/mL). Data for this outcome measure was reported for overall participants.
Time Frame Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS. N (number of participants analyzed) = participants evaluable for this measure. n = participants with serum ferritin values at each timepoint.
Arm/Group Title Methoxy Polyethylene Glycol-epoetin (All Participants)
Hide Arm/Group Description:
Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
Overall Number of Participants Analyzed 807
Mean (Standard Deviation)
Unit of Measure: ng/mL
Month 0 (n=807) 402.5  (365.3)
Month 1 (n=509) 526.5  (453.1)
Month 2 (n=420) 479.9  (451.5)
Month 3 (n=399) 412.6  (349.3)
Month 4 (n=439) 517.4  (423.0)
Month 5 (n=366) 518.2  (424.5)
Month 6 (n=411) 462.0  (403.9)
Month 7 (n=443) 567.1  (514.5)
Month 8 (n=333) 488.4  (414.5)
Month 9 (n=323) 493.0  (414.8)
Month 10 (n=388) 554.8  (431.0)
Month 11 (n=307) 542.3  (416.2)
Month 12 (n=335) 478.6  (354.0)
6.Primary Outcome
Title Serum Iron Values
Hide Description Serum iron levels were measured as microgram/deciliter (mcg/dL). Data for this outcome measure was reported for overall participants.
Time Frame Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS. N (number of participants analyzed) = participants evaluable for this measure. n = participants with serum iron values at each timepoint.
Arm/Group Title Methoxy Polyethylene Glycol-epoetin Beta (All Participants)
Hide Arm/Group Description:
Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
Overall Number of Participants Analyzed 644
Mean (Standard Deviation)
Unit of Measure: mcg/dL
Month 0 (n=644) 73.3  (65.9)
Month 1 (n=339) 69.5  (33.4)
Month 2 (n=351) 68.8  (37.1)
Month 3 (n=375) 74.5  (74.4)
Month 4 (n=362) 67.7  (31.2)
Month 5 (n=323) 68.9  (31.0)
Month 6 (n=347) 72.1  (32.7)
Month 7 (n=362) 74.4  (34.2)
Month 8 (n=294) 67.0  (31.9)
Month 9 (n=284) 74.3  (50.1)
Month 10 (n=341) 69.0  (29.2)
Month 11 (n=263) 64.8  (28.8)
Month 12 (n=263) 70.2  (29.7)
7.Primary Outcome
Title Transferrin Values
Hide Description Transferrin levels were measured as milligram/deciliter (mg/dL). Data for this outcome measure was reported for overall participants.
Time Frame Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS. N (number of participants analyzed) = participants evaluable for this measure. n = participants with tansferrin values at each timepoint.
Arm/Group Title Methoxy Polyethylene Glycol-epoetin Beta (All Participants)
Hide Arm/Group Description:
Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
Overall Number of Participants Analyzed 544
Mean (Standard Deviation)
Unit of Measure: mg/dL
Month 0 (n=544) 196.1  (46.8)
Month 1 (n=266) 187.9  (40.4)
Month 2 (n=271) 192.5  (43.1)
Month 3 (n=274) 192.6  (44.2)
Month 4 (n=292) 187.7  (43.6)
Month 5 (n=231) 193.6  (41.9)
Month 6 (n=282) 193.9  (47.0)
Month 7 (n=287) 188.4  (44.0)
Month 8 (n=199) 192.0  (43.2)
Month 9 (n=205) 188.1  (44.7)
Month 10 (n=251) 182.3  (39.5)
Month 11 (n=175) 186.9  (45.1)
Month 12 (n=179) 189.9  (46.1)
8.Primary Outcome
Title Transferrin Saturation Values
Hide Description Transferrin saturation (TSAT) measured as a percentage, is a medical laboratory test. It is the ratio of serum iron and total iron-binding capacity, multiplied by 100. Data for this outcome measure was reported for overall participants.
Time Frame Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS. N (number of participants analyzed) = participants evaluable for this measure. n = participants with transferrin saturation values at each timepoint.
Arm/Group Title Methoxy Polyethylene Glycol-epoetin Beta (All Participants)
Hide Arm/Group Description:
Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
Overall Number of Participants Analyzed 489
Mean (Standard Deviation)
Unit of Measure: percent transferrin saturation
Month 0 (n=489) 24.4  (11.8)
Month 1 (n=298) 27.3  (15.2)
Month 2 (n=308) 26.7  (13.8)
Month 3 (n=282) 28.0  (13.8)
Month 4 (n=321) 26.4  (12.9)
Month 5 (n=276) 27.5  (14.1)
Month 6 (n=320) 27.2  (13.6)
Month 7 (n=316) 28.2  (13.8)
Month 8 (n=254) 26.8  (14.0)
Month 9 (n=241) 27.4  (12.3)
Month 10 (n=294) 27.3  (12.5)
Month 11 (n=227) 25.7  (12.1)
Month 12 (n=220) 27.0  (11.8)
9.Primary Outcome
Title C-reactive Protein (CRP) Values
Hide Description The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Data for this outcome measure was reported for overall participants.
Time Frame Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS. N (number of participants analyzed) = participants evaluable for this measure. n = participants with C-reactive protein values at each timepoint.
Arm/Group Title Methoxy Polyethylene Glycol-epoetin Beta (All Participants)
Hide Arm/Group Description:
Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
Overall Number of Participants Analyzed 916
Mean (Standard Deviation)
Unit of Measure: mg/dL
Month 0 (n=916) 13.3  (28.5)
Month 1 (n=641) 15.0  (30.7)
Month 2 (n=529) 12.9  (24.1)
Month 3 (n=589) 21.6  (119.2)
Month 4 (n=677) 14.5  (74.8)
Month 5 (n=552) 12.1  (20.6)
Month 6 (n=567) 15.0  (35.8)
Month 7 (n=623) 11.4  (19.0)
Month 8 (n=471) 16.5  (66.0)
Month 9 (n=514) 12.4  (22.0)
Month 10 (n=535) 11.1  (18.2)
Month 11 (n=478) 13.0  (29.6)
Month 12 (n=488) 11.2  (23.4)
10.Primary Outcome
Title Number of Physicians Satisfied With Treatment at Final Visit
Hide Description Physicians were asked to rate their satisfaction with the methoxy polyethyleneglycol-epoetin beta treatment at final visit. Physicians' responses were “very satisfied”, “satisfied”, “undecided”, or “not satisfied”. One physician could analyze multiple participants but for the purpose of analysis each physician was counted as one for each analyzed participants; hence, the number of physicians (as per this assessment) was equal to the number of participants analyzed. Data for this outcome measure was reported for overall participants.
Time Frame Month 12 or early discontinuation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Methoxy Polyethylene Glycol-epoetin Beta (All Participants)
Hide Arm/Group Description:
Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
Overall Number of Participants Analyzed 1510
Measure Type: Number
Unit of Measure: physicians
Very satisfied 685
Satisfied 602
Undecided 136
Not satisfied 31
Missing 56
11.Primary Outcome
Title Number of Participants Who Continued Treatment With Methoxy Polyethyleneglycol-epoetin Beta After Study Completion
Hide Description At final visit, physicians were asked to answer ("yes" or "no") the question, whether they would continue treatment with methoxy polyethyleneglycol-epoetin beta treatment after study completion. Data for this outcome measure was reported for overall participants.
Time Frame Month 12 or early discontinuation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Methoxy Polyethylene Glycol-epoetin Beta (All Participants)
Hide Arm/Group Description:
Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
Overall Number of Participants Analyzed 1510
Measure Type: Number
Unit of Measure: participants
Yes 944
No 490
Missing 76
12.Primary Outcome
Title Number of Participants With Reasons for Discontinuation of Methoxy Polyethyleneglycol-epoetin Beta Treatment After Study Completion
Hide Description At final visit, physicians were asked to state the reasons in case of discontinuation of treatment with methoxy polyethyleneglycol-epoetin beta. The same participant could have discontinued treatment due to multiple reasons. Data for this outcome measure was reported for overall participants.
Time Frame Month 12 or early discontinuation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS. N (number of participants analyzed) = participants evaluable for this measure.
Arm/Group Title Methoxy Polyethylene Glycol-epoetin Beta (All Participants)
Hide Arm/Group Description:
Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
Overall Number of Participants Analyzed 490
Measure Type: Number
Unit of Measure: participants
Participant's decision 24
Physician’s decision 177
Insufficient efficacy 1
Adverse event 5
Missing 10
Death 116
Methoxy polyethylene glycol-epoetin not available 57
Organizational reasons 34
Hospitalization/change of medical center 19
Transplantation 18
Treatment interruption/ESA currently not necessary 14
High hemoglobin levels 10
Relocation/vacation of participant 6
Lost to follow-up 6
Dialysis 5
Unknown 5
Change of therapy 4
Participant does not want to continue dialysis 1
Therapy withdrawal 1
Therapy omission 1
13.Primary Outcome
Title Number of Participants Who Switched to Other Erythropoiesis Stimulating Agents (ESA)-Therapy
Hide Description Number of participants who switched to other ESA therapies including Aranesp, Biopoin, Biosimilar, Erypo, and NeoRecormon is presented. Data for this outcome measure was reported for overall participants.
Time Frame Month 12 or early discontinuation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS. N (number of participants analyzed) = participants evaluable for this measure.
Arm/Group Title Methoxy Polyethylene Glycol-epoetin Beta (All Participants)
Hide Arm/Group Description:
Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
Overall Number of Participants Analyzed 169
Measure Type: Number
Unit of Measure: participants
Aranesp 30
Biopoin 1
Biosimilar 21
Erypo 50
NeoRecormon 46
Missing 21
14.Primary Outcome
Title Number of Participants Satisfied With Treatment at Final Visit
Hide Description Participants were asked to rate their satisfaction with methoxy polyethyleneglycol-epoetin beta treatment at final visit. Participants' responses were “very satisfied”, “satisfied”, “undecided”, or “not satisfied”. Data for this outcome measure was reported for overall participants.
Time Frame Month 12 or early discontinuation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Methoxy Polyethylene Glycol-epoetin Beta (All Participants)
Hide Arm/Group Description:
Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
Overall Number of Participants Analyzed 1510
Measure Type: Number
Unit of Measure: participants
Very satisfied 593
Satisfied 713
Undecided 114
Not satisfied 16
Missing 74
15.Secondary Outcome
Title Average Methoxy Polyethylene Glycol-epoetin Beta Dose
Hide Description Average methoxy polyethylene glycol-epoetin beta dose per application is presented by study month. Mean values were taken when more than 1 application was documented for a participant during the time period considered. Data for this outcome measure was reported for overall participants.
Time Frame Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS. N (number of participants analyzed) = participants evaluable for this measure. n = participants with methoxy polyethylene glycol-epoetin beta dose values during each timepoint.
Arm/Group Title Methoxy Polyethylene Glycol-epoetin Beta (All Participants)
Hide Arm/Group Description:
Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
Overall Number of Participants Analyzed 1485
Mean (Standard Deviation)
Unit of Measure: mcg
Month 0 (n=1485) 109.1  (75.9)
Month 1 (n=1336) 121.8  (102.2)
Month 2 (n=1292) 124.6  (96.7)
Month 3 (n=1234) 126.2  (94.1)
Month 4 (n=1192) 129.4  (99.8)
Month 5 (n=1157) 130.5  (110.2)
Month 6 (n=1115) 128.3  (101.7)
Month 7 (n=1075) 129.3  (105.1)
Month 8 (n=1014) 125.7  (101.9)
Month 9 (n=993) 122.9  (98.2)
Month 10 (n=954) 124.3  (101.7)
Month 11 (n=917) 124.5  (106.3)
Month 12 (n=907) 121.1  (99.1)
Time Frame Month 0 to Month 12
Adverse Event Reporting Description Safety Analysis Set: all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta during the study course.
 
Arm/Group Title Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis)
Hide Arm/Group Description Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary. Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
All-Cause Mortality
Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis)
Affected / at Risk (%) Affected / at Risk (%)
Total   7/346 (2.02%)   67/1201 (5.58%) 
Blood and lymphatic system disorders     
Haemolysis * 1  0/346 (0.00%)  1/1201 (0.08%) 
Haemorrhagic anaemia * 1  0/346 (0.00%)  1/1201 (0.08%) 
Cardiac disorders     
Atrial fibrillation * 1  0/346 (0.00%)  1/1201 (0.08%) 
Cardiac failure * 1  0/346 (0.00%)  3/1201 (0.25%) 
Cardiovascular disorder * 1  0/346 (0.00%)  2/1201 (0.17%) 
Ischaemic cardiomyopathy * 1  0/346 (0.00%)  1/1201 (0.08%) 
Myocardial infarction * 1  0/346 (0.00%)  2/1201 (0.17%) 
Myocarditis * 1  0/346 (0.00%)  1/1201 (0.08%) 
Gastrointestinal disorders     
Diverticulum intestinal * 1  0/346 (0.00%)  1/1201 (0.08%) 
Gastric haemorrhage * 1  0/346 (0.00%)  1/1201 (0.08%) 
Gastric polyps * 1  0/346 (0.00%)  1/1201 (0.08%) 
Gastritis haemorrhagic * 1  0/346 (0.00%)  1/1201 (0.08%) 
Gastrointestinal angiodysplasia * 1  0/346 (0.00%)  1/1201 (0.08%) 
Gastrointestinal haemorrhage * 1  0/346 (0.00%)  7/1201 (0.58%) 
Haematemesis * 1  0/346 (0.00%)  1/1201 (0.08%) 
Intestinal polyp * 1  0/346 (0.00%)  1/1201 (0.08%) 
Lower gastrointestinal haemorrhage * 1  0/346 (0.00%)  1/1201 (0.08%) 
Melaena * 1  0/346 (0.00%)  1/1201 (0.08%) 
Small intestinal perforation * 1  0/346 (0.00%)  1/1201 (0.08%) 
General disorders     
Death * 1  1/346 (0.29%)  5/1201 (0.42%) 
General physical health deterioration * 1  0/346 (0.00%)  1/1201 (0.08%) 
Multi-organ failure * 1  0/346 (0.00%)  1/1201 (0.08%) 
Sudden cardiac death * 1  0/346 (0.00%)  1/1201 (0.08%) 
Ulcer haemorrhage * 1  0/346 (0.00%)  1/1201 (0.08%) 
Hepatobiliary disorders     
Drug-induced liver injury * 1  0/346 (0.00%)  1/1201 (0.08%) 
Infections and infestations     
Bacterial infection * 1  0/346 (0.00%)  1/1201 (0.08%) 
Bronchitis * 1  0/346 (0.00%)  1/1201 (0.08%) 
Campylobacter gastroenteritis * 1  0/346 (0.00%)  1/1201 (0.08%) 
Device related infection * 1  0/346 (0.00%)  1/1201 (0.08%) 
Infection * 1  0/346 (0.00%)  3/1201 (0.25%) 
Nasopharyngitis * 1  0/346 (0.00%)  1/1201 (0.08%) 
Peritonitis * 1  0/346 (0.00%)  1/1201 (0.08%) 
Pneumonia * 1  0/346 (0.00%)  3/1201 (0.25%) 
Psoas abscess * 1  0/346 (0.00%)  1/1201 (0.08%) 
Sepsis * 1  1/346 (0.29%)  4/1201 (0.33%) 
Urinary tract infection * 1  0/346 (0.00%)  1/1201 (0.08%) 
Injury, poisoning and procedural complications     
Overdose * 1  0/346 (0.00%)  1/1201 (0.08%) 
Post procedural haemorrhage * 1  0/346 (0.00%)  1/1201 (0.08%) 
Shunt stenosis * 1  0/346 (0.00%)  1/1201 (0.08%) 
Wound dehiscence * 1  0/346 (0.00%)  1/1201 (0.08%) 
Investigations     
Haemoglobin decreased * 1  4/346 (1.16%)  16/1201 (1.33%) 
Platelet count decreased * 1  0/346 (0.00%)  1/1201 (0.08%) 
White blood cell count decreased * 1  0/346 (0.00%)  1/1201 (0.08%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bronchial carcinoma * 1  0/346 (0.00%)  1/1201 (0.08%) 
Myelodysplastic syndrome * 1  0/346 (0.00%)  1/1201 (0.08%) 
Prostate cancer * 1  0/346 (0.00%)  1/1201 (0.08%) 
Nervous system disorders     
Cerebral ischaemia * 1  0/346 (0.00%)  1/1201 (0.08%) 
Cerebrovascular accident * 1  0/346 (0.00%)  1/1201 (0.08%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure * 1  0/346 (0.00%)  1/1201 (0.08%) 
Pulmonary embolism * 1  0/346 (0.00%)  1/1201 (0.08%) 
Pulmonary oedema * 1  0/346 (0.00%)  1/1201 (0.08%) 
Surgical and medical procedures     
Amputation * 1  0/346 (0.00%)  1/1201 (0.08%) 
Arteriovenous shunt operation * 1  1/346 (0.29%)  0/1201 (0.00%) 
Leg amputation * 1  0/346 (0.00%)  1/1201 (0.08%) 
Nephrectomy * 1  0/346 (0.00%)  1/1201 (0.08%) 
Vascular disorders     
Aortic aneurysm rupture * 1  0/346 (0.00%)  1/1201 (0.08%) 
Thrombosis * 1  0/346 (0.00%)  1/1201 (0.08%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 16.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis)
Affected / at Risk (%) Affected / at Risk (%)
Total   13/346 (3.76%)   196/1201 (16.32%) 
Investigations     
Haemoglobin decreased * 1  13/346 (3.76%)  196/1201 (16.32%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 16.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Medical Communications
Organization: Hoffmann-LaRoche
Phone: 800-821-8590
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01051323     History of Changes
Other Study ID Numbers: ML22714
First Submitted: January 15, 2010
First Posted: January 18, 2010
Results First Submitted: November 17, 2015
Results First Posted: December 18, 2015
Last Update Posted: December 18, 2015