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

NCT01051323 | Completed Results

• 1 other identifier: ML22714
• Study Type: observational
• Target: 1,580
• Locations: 1 country
• Sites: 1

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.

Conditions

Anemia

Outcome Measures

Primary Outcomes (14)

• Percentage of Participants With at Least One Hemoglobin Value Outside the Target Range

  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.

  Month 0 to Month 12

• Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size

  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.

  Month 0 to Month 12

• Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size

  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.

  Month 6 to Month 12

• Maximum Intra-Individual Fluctuation of Hemoglobin Values by Predialysis/Hemodialysis, Age, and Center Size

  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.

  Month 0 to Month 12

• Serum Ferritin Values

  Serum ferritin levels were measured as nanogram/milliliter (ng/mL). Data for this outcome measure was reported for overall participants.

  Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12

• Serum Iron Values

  Serum iron levels were measured as microgram/deciliter (mcg/dL). Data for this outcome measure was reported for overall participants.

  Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12

• Transferrin Values

  Transferrin levels were measured as milligram/deciliter (mg/dL). Data for this outcome measure was reported for overall participants.

  Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12

• Transferrin Saturation Values

  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.

  Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12

• C-reactive Protein (CRP) Values

  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.

  Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12

• Number of Physicians Satisfied With Treatment at Final Visit

  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.

  Month 12 or early discontinuation

• Number of Participants Who Continued Treatment With Methoxy Polyethyleneglycol-epoetin Beta After Study Completion

  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.

  Month 12 or early discontinuation

• Number of Participants With Reasons for Discontinuation of Methoxy Polyethyleneglycol-epoetin Beta Treatment After Study Completion

  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.

  Month 12 or early discontinuation

• Number of Participants Who Switched to Other Erythropoiesis Stimulating Agents (ESA)-Therapy

  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.

  Month 12 or early discontinuation

• Number of Participants Satisfied With Treatment at Final Visit

  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.

  Month 12 or early discontinuation

Secondary Outcomes (1)

• Average Methoxy Polyethylene Glycol-epoetin Beta Dose

  Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12

Study Arms (1)

1

Drug: methoxy polyethylene glycol-ep [Mircera]

Interventions

methoxy polyethylene glycol-ep [Mircera] DRUG

As prescribed by physician

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

CKD patients treated with Mirecera at different medical centers

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Saarlouis, 66740, Germany

Location

MeSH Terms

Conditions

Anemia

Interventions

continuous erythropoietin receptor activator

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-LaRoche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2010
• First Posted: January 18, 2010
• Study Start: March 1, 2010
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: December 18, 2015
• Results First Posted: December 18, 2015

Record last verified: 2015-11

Locations

DE (1)