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

Completed

• Conditions: Anemia
• Interventions: Drug: methoxy polyethylene glycol-ep [Mircera]

• Registration Number: NCT01051323
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-01-15
• Study First Submitted QC: 2010-01-15
• Study First Posted: 2010-01-18
• Study Start: 2010-03
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2015-11
• Results First Submitted: 2015-11-17
• Results First Submitted QC: 2015-11-17
• Last Update Submitted: 2015-11-17
• Results First Posted: 2015-12-18
• Last Update Posted: 2015-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1580

Inclusion Criteria

• adult patients, >/= 18 years of age
• chronic kidney disease
• informed consent for data transmission

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	methoxy polyethylene glycol-ep [Mircera]	-

Primary Outcome Measures

Name	Time	Method
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.
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.
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.
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 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 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.
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.

Secondary Outcome Measures

Name	Time	Method
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.