Trial · NCT01051323
An Observational Study of Mircera (Methoxy Polyethylene Glycol-epoetin Beta) in Patients With Renal Anemia
NCT01051323, Completed, Hoffmann-La Roche; results first posted 2015-12-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Observational Study of Mircera (Methoxy Polyethylene Glycol-epoetin Beta) in Patients With Renal Anemia. Trials, record NCT01051323. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01051323
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Observational Study of Mircera (Methoxy Polyethylene Glycol-epoetin Beta) in Patients With Renal Anemia
- NCT number
- NCT01051323
- Status
- Completed
- Enrollment
- 1,580 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Anemia
- Interventions
- methoxy polyethylene glycol-ep [Mircera]
- First posted
- 2010-01-18
- Last updated
- 2015-12-18
- Results first posted
- 2015-12-18
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With at Least One Hemoglobin Value Outside the Target Range | Month 0 to Month 12 | FAS | percentage of participants | NUMBER |
| PRIMARY | 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 | FAS. n = participants evaluable for specified category for each arm group, respectively. | percentage of participants | NUMBER |
| PRIMARY | 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 | FAS. n = participants evaluable for specified category for each arm group, respectively. | percentage of participants | NUMBER |
| PRIMARY | Maximum Intra-Individual Fluctuation of Hemoglobin Values by Predialysis/Hemodialysis, Age, and Center Size | Month 0 to Month 12 | FAS. N (number of participants analyzed) = participants evaluable for this measure. n = participants evaluable for specified category. | g/dL | MEAN |
| PRIMARY | Serum Ferritin Values | Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 | FAS. N (number of participants analyzed) = participants evaluable for this measure. n = participants with serum ferritin values at each timepoint. | ng/mL | MEAN |
| PRIMARY | Serum Iron Values | Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 | FAS. N (number of participants analyzed) = participants evaluable for this measure. n = participants with serum iron values at each timepoint. | mcg/dL | MEAN |
| PRIMARY | Transferrin Values | Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 | FAS. N (number of participants analyzed) = participants evaluable for this measure. n = participants with tansferrin values at each timepoint. | mg/dL | MEAN |
| PRIMARY | Transferrin Saturation Values | Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 | FAS. N (number of participants analyzed) = participants evaluable for this measure. n = participants with transferrin saturation values at each timepoint. | percent transferrin saturation | MEAN |
| PRIMARY | C-reactive Protein (CRP) Values | Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 | FAS. N (number of participants analyzed) = participants evaluable for this measure. n = participants with C-reactive protein values at each timepoint. | mg/dL | MEAN |
| PRIMARY | Number of Physicians Satisfied With Treatment at Final Visit | Month 12 or early discontinuation | FAS | physicians | NUMBER |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group199
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With at Least One Hemoglobin Value Outside the Target Range | Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Hemoglobin value <10 g/dL | 97.9 | percentage of participants | |
| Percentage of Participants With at Least One Hemoglobin Value Outside the Target Range | Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis) | Hemoglobin value <10 g/dL | 72.9 | percentage of participants | |
| Percentage of Participants With at Least One Hemoglobin Value Outside the Target Range | Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | Hemoglobin value >13 g/dL | 33.7 | percentage of participants | |
| Percentage of Participants With at Least One Hemoglobin Value Outside the Target Range | Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis) | Hemoglobin value >13 g/dL | 35.3 | percentage of participants | |
| Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size | Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | No dose modifications: Hb 10-12 g/dL (n=157, 242) | 11.5 | percentage of participants | |
| Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size | Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis) | No dose modifications: Hb 10-12 g/dL (n=157, 242) | 8.7 | percentage of participants | |
| Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size | Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | No dose modifications: Hb 11-12 g/dL (n=157, 242) | 0.6 | percentage of participants | |
| Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size | Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis) | No dose modifications: Hb 11-12 g/dL (n=157, 242) | 0.8 | percentage of participants | |
| Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size | Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | No dose modifications: Hb 11-13 g/dL (n=157, 242) | 11.5 | percentage of participants | |
| Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size | Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis) | No dose modifications: Hb 11-13 g/dL (n=157, 242) | 11.2 | percentage of participants |
1 to 10 of 199Source ClinicalTrials.gov
See all 199 results by groupParticipant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Methoxy Polyethylene Glycol-epoetin Beta (All Participants) | 1,580 | |
| Overall Study | Received at Least One Dose | Methoxy Polyethylene Glycol-epoetin Beta (All Participants) | 1,547 | |
| Overall Study | COMPLETED | Methoxy Polyethylene Glycol-epoetin Beta (All Participants) | 1,041 | |
| Overall Study | NOT COMPLETED | Methoxy Polyethylene Glycol-epoetin Beta (All Participants) | 539 |
Source ClinicalTrials.gov
Adverse events116
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Haemoglobin decreased | Investigations | Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | 13 | 346 | |
| other | Haemoglobin decreased | Investigations | Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis) | 196 | 1,201 | |
| serious | Haemolysis | Blood and lymphatic system disorders | Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | 0 | 346 | |
| serious | Haemolysis | Blood and lymphatic system disorders | Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis) | 1 | 1,201 | |
| serious | Haemorrhagic anaemia | Blood and lymphatic system disorders | Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | 0 | 346 | |
| serious | Haemorrhagic anaemia | Blood and lymphatic system disorders | Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis) | 1 | 1,201 | |
| serious | Atrial fibrillation | Cardiac disorders | Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | 0 | 346 | |
| serious | Atrial fibrillation | Cardiac disorders | Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis) | 1 | 1,201 | |
| serious | Cardiac failure | Cardiac disorders | Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | 0 | 346 | |
| serious | Cardiac failure | Cardiac disorders | Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis) | 3 | 1,201 |
1 to 10 of 116Source ClinicalTrials.gov
See all 116 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | ||
| Total, all-cause mortality | Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis) | ||
| Total, other adverse events | Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | 13 | 346 |
| Total, other adverse events | Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis) | 196 | 1,201 |
| Total, serious adverse events | Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) | 7 | 346 |
| Total, serious adverse events | Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis) | 67 | 1,201 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Methoxy Polyethylene Glycol-epoetin Beta (Predialysis) vs Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis): serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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GET https://conductscience.org/api/trials/v1/NCT01051323/results?page=2