An Observational Study of Mircera (Methoxy Polyethylene Glycol-epoetin Beta) in Patients With Renal Anemia
Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Completed
CT.gov ID
NCT01051323
Collaborator
(none)
1,580
1
35.1
45
Study Details
Study Description
Brief Summary
This observational study will investigate hemoglobin levels and Mircera (methoxy polyethyleneglycol-epoetin beta) dose over time in patients with chronic kidney disease, and compare standards of care between centers. Data from each patient will be collected over 12 months of Mircera therapy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
1580 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Non-interventional Study to Investigate Hemoglobin Levels and Dose Over Time in the Daily Use of Mircera for Renal Anemia in Larger Centers, and to Detect Differences Between Standard of Care in the Centers
Study Start Date
:
Mar 1, 2010
Actual Primary Completion Date
:
Feb 1, 2013
Actual Study Completion Date
:
Feb 1, 2013
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 1
|
Drug: methoxy polyethylene glycol-ep [Mircera]
As prescribed by physician
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants With at Least One Hemoglobin Value Outside the Target Range [Month 0 to Month 12]
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.
- Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size [Month 0 to Month 12]
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.
- Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size [Month 6 to Month 12]
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.
- Maximum Intra-Individual Fluctuation of Hemoglobin Values by Predialysis/Hemodialysis, Age, and Center Size [Month 0 to Month 12]
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.
- Serum Ferritin Values [Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12]
Serum ferritin levels were measured as nanogram/milliliter (ng/mL). Data for this outcome measure was reported for overall participants.
- Serum Iron Values [Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12]
Serum iron levels were measured as microgram/deciliter (mcg/dL). Data for this outcome measure was reported for overall participants.
- Transferrin Values [Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12]
Transferrin levels were measured as milligram/deciliter (mg/dL). Data for this outcome measure was reported for overall participants.
- Transferrin Saturation Values [Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12]
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.
- C-reactive Protein (CRP) Values [Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12]
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.
- Number of Physicians Satisfied With Treatment at Final Visit [Month 12 or early discontinuation]
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.
- Number of Participants Who Continued Treatment With Methoxy Polyethyleneglycol-epoetin Beta After Study Completion [Month 12 or early discontinuation]
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.
- Number of Participants With Reasons for Discontinuation of Methoxy Polyethyleneglycol-epoetin Beta Treatment After Study Completion [Month 12 or early discontinuation]
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.
- Number of Participants Who Switched to Other Erythropoiesis Stimulating Agents (ESA)-Therapy [Month 12 or early discontinuation]
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.
- Number of Participants Satisfied With Treatment at Final Visit [Month 12 or early discontinuation]
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.
Secondary Outcome Measures
- Average Methoxy Polyethylene Glycol-epoetin Beta Dose [Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12]
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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
adult patients, >/= 18 years of age
-
chronic kidney disease
-
informed consent for data transmission
Exclusion Criteria:
-
serious hematological or infectious disease
-
acute bleeding in the 16 weeks preceding data collection
-
participation in an interventional trial
-
female patients: pregnancy or breast-feeding
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Saarlouis | Germany | 66740 |
Sponsors and Collaborators
- Hoffmann-La Roche
Investigators
- Study Director: Clinical Trials, Hoffmann-La Roche
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01051323
Other Study ID Numbers:
- ML22714
First Posted:
Jan 18, 2010
Last Update Posted:
Dec 18, 2015
Last Verified:
Nov 1, 2015
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | 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) |
|---|---|
| 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 |
Baseline Characteristics
| Arm/Group Title | Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis) | Total |
|---|---|---|---|
| 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 Participants | 326 | 1184 | 1510 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
71.8
(13.3)
|
68.0
(13.8)
|
68.8
(13.8)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
158
48.5%
|
479
40.5%
|
637
42.2%
|
| Male |
168
51.5%
|
705
59.5%
|
873
57.8%
|
Outcome Measures
| Title | Percentage of Participants With at Least One Hemoglobin Value Outside the Target Range |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS |
| Arm/Group Title | Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis) |
|---|---|---|
| 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. |
| Measure Participants | 326 | 1184 |
| Hemoglobin value <10 g/dL |
97.9
30%
|
72.9
6.2%
|
| Hemoglobin value >13 g/dL |
33.7
10.3%
|
35.3
3%
|
| Title | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size |
|---|---|
| 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 |
Outcome Measure Data
| 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) |
|---|---|---|
| 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. |
| Measure Participants | 326 | 1184 |
| No dose modifications: Hb 10-12 g/dL (n=157, 242) |
11.5
3.5%
|
8.7
0.7%
|
| No dose modifications: Hb 11-12 g/dL (n=157, 242) |
0.6
0.2%
|
0.8
0.1%
|
| No dose modifications: Hb 11-13 g/dL (n=157, 242) |
11.5
3.5%
|
11.2
0.9%
|
| With dose modifications: Hb 10-12g/dL (n=169, 942) |
6.5
2%
|
4.9
0.4%
|
| With dose modifications: Hb 11-12g/dL (n=169, 942) |
0.6
0.2%
|
0.1
0%
|
| With dose modifications: Hb 11-13g/dL (n=169, 942) |
8.9
2.7%
|
5.2
0.4%
|
| Age <65 years: Hb 10-12 g/dL (n=70, 402) |
10.0
3.1%
|
6.7
0.6%
|
| Age <65 years: Hb 11-12 g/dL (n=70, 402) |
1.4
0.4%
|
0.5
0%
|
| Age <65 years: Hb 11-13 g/dL (n=70, 402) |
8.6
2.6%
|
8.8
0.7%
|
| Age >=65 years: Hb 10-12 g/dL (n=256, 782) |
8.6
2.6%
|
5.1
0.4%
|
| Age >=65 years: Hb 11-12 g/dL (n=256, 782) |
0.4
0.1%
|
0.1
0%
|
| Age >=65 years: Hb 11-13 g/dL (n=256, 782) |
10.5
3.2%
|
5.4
0.5%
|
| Center size >100: Hb 10-12 g/dL (n=99, 563) |
17.2
5.3%
|
6.0
0.5%
|
| Center size >100: Hb 11-12 g/dL (n=99, 563) |
2.0
0.6%
|
0.4
0%
|
| Center size >100: Hb 11-13 g/dL (n=99, 563) |
13.1
4%
|
7.5
0.6%
|
| Center size <=100: Hb 10-12 g/dL (n=227, 621) |
5.3
1.6%
|
5.3
0.4%
|
| Center size <=100: Hb 11-12 g/dL (n=227, 621) |
0
0%
|
0.2
0%
|
| Center size <=100: Hb 11-13 g/dL (n=227, 621) |
8.8
2.7%
|
5.5
0.5%
|
| Title | Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size |
|---|---|
| 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 |
Outcome Measure Data
| 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) |
|---|---|---|
| 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. |
| Measure Participants | 326 | 1184 |
| No dose modifications: Hb 10-12 g/dL (n=157, 242) |
9.6
2.9%
|
12.8
1.1%
|
| No dose modifications: Hb 11-12 g/dL (n=157, 242) |
3.2
1%
|
2.5
0.2%
|
| No dose modifications: Hb 11-13 g/dL (n=157, 242) |
8.3
2.5%
|
12.8
1.1%
|
| With dose modifications: Hb 10-12g/dL (n=169, 942) |
10.7
3.3%
|
14.6
1.2%
|
| With dose modifications: Hb 11-12g/dL (n=169, 942) |
1.2
0.4%
|
2.3
0.2%
|
| With dose modifications: Hb 11-13g/dL (n=169, 942) |
9.5
2.9%
|
15.1
1.3%
|
| Age <65 years: Hb 10-12 g/dL (n=70, 402) |
11.4
3.5%
|
14.7
1.2%
|
| Age <65 years: Hb 11-12 g/dL (n=70, 402) |
4.3
1.3%
|
3.0
0.3%
|
| Age <65 years: Hb 11-13 g/dL (n=70, 402) |
12.9
4%
|
18.4
1.6%
|
| Age >=65 years: Hb 10-12 g/dL (n=256, 782) |
9.8
3%
|
14.1
1.2%
|
| Age >=65 years: Hb 11-12 g/dL (n=256, 782) |
1.6
0.5%
|
2.0
0.2%
|
| Age >=65 years: Hb 11-13 g/dL (n=256, 782) |
7.8
2.4%
|
12.7
1.1%
|
| Center size >100: Hb 10-12 g/dL (n=99, 563) |
20.2
6.2%
|
14.9
1.3%
|
| Center size >100: Hb 11-12 g/dL (n=99, 563) |
7.1
2.2%
|
3.4
0.3%
|
| Center size >100: Hb 11-13 g/dL (n=99, 563) |
15.2
4.7%
|
15.1
1.3%
|
| Center size <=100: Hb 10-12 g/dL (n=227, 621) |
5.7
1.7%
|
13.7
1.2%
|
| Center size <=100: Hb 11-12 g/dL (n=227, 621) |
0
0%
|
1.4
0.1%
|
| Center size <=100: Hb 11-13 g/dL (n=227, 621) |
6.2
1.9%
|
14.2
1.2%
|
| Title | Maximum Intra-Individual Fluctuation of Hemoglobin Values by Predialysis/Hemodialysis, Age, and Center Size |
|---|---|
| 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 |
Outcome Measure Data
| 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) |
|---|---|
| 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. |
| Measure Participants | 1489 |
| 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)
|
| Title | Serum Ferritin Values |
|---|---|
| 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 |
Outcome Measure Data
| 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) |
|---|---|
| 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. |
| Measure Participants | 807 |
| 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)
|
| Title | Serum Iron Values |
|---|---|
| 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 |
Outcome Measure Data
| 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) |
|---|---|
| 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. |
| Measure Participants | 644 |
| 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)
|
| Title | Transferrin Values |
|---|---|
| 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 |
Outcome Measure Data
| 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) |
|---|---|
| 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. |
| Measure Participants | 544 |
| 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)
|
| Title | Transferrin Saturation Values |
|---|---|
| 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 |
Outcome Measure Data
| 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) |
|---|---|
| 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. |
| Measure Participants | 489 |
| 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)
|
| Title | C-reactive Protein (CRP) Values |
|---|---|
| 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 |
Outcome Measure Data
| 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) |
|---|---|
| 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. |
| Measure Participants | 916 |
| 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)
|
| Title | Number of Physicians Satisfied With Treatment at Final Visit |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS |
| Arm/Group Title | Methoxy Polyethylene Glycol-epoetin Beta (All Participants) |
|---|---|
| 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. |
| Measure Participants | 1510 |
| Very satisfied |
685
|
| Satisfied |
602
|
| Undecided |
136
|
| Not satisfied |
31
|
| Missing |
56
|
| Title | Number of Participants Who Continued Treatment With Methoxy Polyethyleneglycol-epoetin Beta After Study Completion |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS |
| Arm/Group Title | Methoxy Polyethylene Glycol-epoetin Beta (All Participants) |
|---|---|
| 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. |
| Measure Participants | 1510 |
| Yes |
944
289.6%
|
| No |
490
150.3%
|
| Missing |
76
23.3%
|
| Title | Number of Participants With Reasons for Discontinuation of Methoxy Polyethyleneglycol-epoetin Beta Treatment After Study Completion |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS. N (number of participants analyzed) = participants evaluable for this measure. |
| Arm/Group Title | Methoxy Polyethylene Glycol-epoetin Beta (All Participants) |
|---|---|
| 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. |
| Measure Participants | 490 |
| Participant's decision |
24
7.4%
|
| Physician's decision |
177
54.3%
|
| Insufficient efficacy |
1
0.3%
|
| Adverse event |
5
1.5%
|
| Missing |
10
3.1%
|
| Death |
116
35.6%
|
| Methoxy polyethylene glycol-epoetin not available |
57
17.5%
|
| Organizational reasons |
34
10.4%
|
| Hospitalization/change of medical center |
19
5.8%
|
| Transplantation |
18
5.5%
|
| Treatment interruption/ESA currently not necessary |
14
4.3%
|
| High hemoglobin levels |
10
3.1%
|
| Relocation/vacation of participant |
6
1.8%
|
| Lost to follow-up |
6
1.8%
|
| Dialysis |
5
1.5%
|
| Unknown |
5
1.5%
|
| Change of therapy |
4
1.2%
|
| Participant does not want to continue dialysis |
1
0.3%
|
| Therapy withdrawal |
1
0.3%
|
| Therapy omission |
1
0.3%
|
| Title | Number of Participants Who Switched to Other Erythropoiesis Stimulating Agents (ESA)-Therapy |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS. N (number of participants analyzed) = participants evaluable for this measure. |
| Arm/Group Title | Methoxy Polyethylene Glycol-epoetin Beta (All Participants) |
|---|---|
| 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. |
| Measure Participants | 169 |
| Aranesp |
30
9.2%
|
| Biopoin |
1
0.3%
|
| Biosimilar |
21
6.4%
|
| Erypo |
50
15.3%
|
| NeoRecormon |
46
14.1%
|
| Missing |
21
6.4%
|
| Title | Number of Participants Satisfied With Treatment at Final Visit |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| FAS |
| Arm/Group Title | Methoxy Polyethylene Glycol-epoetin Beta (All Participants) |
|---|---|
| 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. |
| Measure Participants | 1510 |
| Very satisfied |
593
181.9%
|
| Satisfied |
713
218.7%
|
| Undecided |
114
35%
|
| Not satisfied |
16
4.9%
|
| Missing |
74
22.7%
|
| Title | Average Methoxy Polyethylene Glycol-epoetin Beta Dose |
|---|---|
| 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 |
Outcome Measure Data
| 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) |
|---|---|
| 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. |
| Measure Participants | 1485 |
| 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)
|
Adverse Events
| 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) | ||
| 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 (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 7/346 (2%) | 67/1201 (5.6%) | ||
| Blood and lymphatic system disorders | ||||
| Haemolysis | 0/346 (0%) | 1/1201 (0.1%) | ||
| Haemorrhagic anaemia | 0/346 (0%) | 1/1201 (0.1%) | ||
| Cardiac disorders | ||||
| Atrial fibrillation | 0/346 (0%) | 1/1201 (0.1%) | ||
| Cardiac failure | 0/346 (0%) | 3/1201 (0.2%) | ||
| Cardiovascular disorder | 0/346 (0%) | 2/1201 (0.2%) | ||
| Ischaemic cardiomyopathy | 0/346 (0%) | 1/1201 (0.1%) | ||
| Myocardial infarction | 0/346 (0%) | 2/1201 (0.2%) | ||
| Myocarditis | 0/346 (0%) | 1/1201 (0.1%) | ||
| Gastrointestinal disorders | ||||
| Diverticulum intestinal | 0/346 (0%) | 1/1201 (0.1%) | ||
| Gastric haemorrhage | 0/346 (0%) | 1/1201 (0.1%) | ||
| Gastric polyps | 0/346 (0%) | 1/1201 (0.1%) | ||
| Gastritis haemorrhagic | 0/346 (0%) | 1/1201 (0.1%) | ||
| Gastrointestinal angiodysplasia | 0/346 (0%) | 1/1201 (0.1%) | ||
| Gastrointestinal haemorrhage | 0/346 (0%) | 7/1201 (0.6%) | ||
| Haematemesis | 0/346 (0%) | 1/1201 (0.1%) | ||
| Intestinal polyp | 0/346 (0%) | 1/1201 (0.1%) | ||
| Lower gastrointestinal haemorrhage | 0/346 (0%) | 1/1201 (0.1%) | ||
| Melaena | 0/346 (0%) | 1/1201 (0.1%) | ||
| Small intestinal perforation | 0/346 (0%) | 1/1201 (0.1%) | ||
| General disorders | ||||
| Death | 1/346 (0.3%) | 5/1201 (0.4%) | ||
| General physical health deterioration | 0/346 (0%) | 1/1201 (0.1%) | ||
| Multi-organ failure | 0/346 (0%) | 1/1201 (0.1%) | ||
| Sudden cardiac death | 0/346 (0%) | 1/1201 (0.1%) | ||
| Ulcer haemorrhage | 0/346 (0%) | 1/1201 (0.1%) | ||
| Hepatobiliary disorders | ||||
| Drug-induced liver injury | 0/346 (0%) | 1/1201 (0.1%) | ||
| Infections and infestations | ||||
| Bacterial infection | 0/346 (0%) | 1/1201 (0.1%) | ||
| Bronchitis | 0/346 (0%) | 1/1201 (0.1%) | ||
| Campylobacter gastroenteritis | 0/346 (0%) | 1/1201 (0.1%) | ||
| Device related infection | 0/346 (0%) | 1/1201 (0.1%) | ||
| Infection | 0/346 (0%) | 3/1201 (0.2%) | ||
| Nasopharyngitis | 0/346 (0%) | 1/1201 (0.1%) | ||
| Peritonitis | 0/346 (0%) | 1/1201 (0.1%) | ||
| Pneumonia | 0/346 (0%) | 3/1201 (0.2%) | ||
| Psoas abscess | 0/346 (0%) | 1/1201 (0.1%) | ||
| Sepsis | 1/346 (0.3%) | 4/1201 (0.3%) | ||
| Urinary tract infection | 0/346 (0%) | 1/1201 (0.1%) | ||
| Injury, poisoning and procedural complications | ||||
| Overdose | 0/346 (0%) | 1/1201 (0.1%) | ||
| Post procedural haemorrhage | 0/346 (0%) | 1/1201 (0.1%) | ||
| Shunt stenosis | 0/346 (0%) | 1/1201 (0.1%) | ||
| Wound dehiscence | 0/346 (0%) | 1/1201 (0.1%) | ||
| Investigations | ||||
| Haemoglobin decreased | 4/346 (1.2%) | 16/1201 (1.3%) | ||
| Platelet count decreased | 0/346 (0%) | 1/1201 (0.1%) | ||
| White blood cell count decreased | 0/346 (0%) | 1/1201 (0.1%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Bronchial carcinoma | 0/346 (0%) | 1/1201 (0.1%) | ||
| Myelodysplastic syndrome | 0/346 (0%) | 1/1201 (0.1%) | ||
| Prostate cancer | 0/346 (0%) | 1/1201 (0.1%) | ||
| Nervous system disorders | ||||
| Cerebral ischaemia | 0/346 (0%) | 1/1201 (0.1%) | ||
| Cerebrovascular accident | 0/346 (0%) | 1/1201 (0.1%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Acute respiratory failure | 0/346 (0%) | 1/1201 (0.1%) | ||
| Pulmonary embolism | 0/346 (0%) | 1/1201 (0.1%) | ||
| Pulmonary oedema | 0/346 (0%) | 1/1201 (0.1%) | ||
| Surgical and medical procedures | ||||
| Amputation | 0/346 (0%) | 1/1201 (0.1%) | ||
| Arteriovenous shunt operation | 1/346 (0.3%) | 0/1201 (0%) | ||
| Leg amputation | 0/346 (0%) | 1/1201 (0.1%) | ||
| Nephrectomy | 0/346 (0%) | 1/1201 (0.1%) | ||
| Vascular disorders | ||||
| Aortic aneurysm rupture | 0/346 (0%) | 1/1201 (0.1%) | ||
| Thrombosis | 0/346 (0%) | 1/1201 (0.1%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 13/346 (3.8%) | 196/1201 (16.3%) | ||
| Investigations | ||||
| Haemoglobin decreased | 13/346 (3.8%) | 196/1201 (16.3%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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 |
| genentech@druginfo.com |
Responsible Party:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01051323
Other Study ID Numbers:
- ML22714
First Posted:
Jan 18, 2010
Last Update Posted:
Dec 18, 2015
Last Verified:
Nov 1, 2015