Trial · NCT01051323
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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 | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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