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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01051323
First received: January 15, 2010
Last updated: November 17, 2015
Last verified: November 2015
  Purpose
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 Intervention
Anemia
Drug: methoxy polyethylene glycol-ep [Mircera]

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of Participants With at Least One Hemoglobin Value Outside the Target Range [ Time Frame: Month 0 to Month 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Month 0 to Month 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Month 6 to Month 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Month 0 to Month 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 ] [ Designated as safety issue: No ]
    Serum ferritin levels were measured as nanogram/milliliter (ng/mL). Data for this outcome measure was reported for overall participants.

  • Serum Iron Values [ Time Frame: Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 ] [ Designated as safety issue: No ]
    Serum iron levels were measured as microgram/deciliter (mcg/dL). Data for this outcome measure was reported for overall participants.

  • Transferrin Values [ Time Frame: Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 ] [ Designated as safety issue: No ]
    Transferrin levels were measured as milligram/deciliter (mg/dL). Data for this outcome measure was reported for overall participants.

  • Transferrin Saturation Values [ Time Frame: Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Month 12 or early discontinuation ] [ Designated as safety issue: No ]
    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 [ Time Frame: Month 12 or early discontinuation ] [ Designated as safety issue: No ]
    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 [ Time Frame: Month 12 or early discontinuation ] [ Designated as safety issue: No ]
    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 [ Time Frame: Month 12 or early discontinuation ] [ Designated as safety issue: No ]
    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 [ Time Frame: Month 12 or early discontinuation ] [ Designated as safety issue: No ]
    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 [ Time Frame: Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 ] [ Designated as safety issue: No ]
    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.


Enrollment: 1580
Study Start Date: March 2010
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1 Drug: methoxy polyethylene glycol-ep [Mircera]
As prescribed by physician

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
CKD patients treated with Mirecera at different medical centers
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01051323

Locations
Germany
Saarlouis, Germany, 66740
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01051323     History of Changes
Other Study ID Numbers: ML22714 
Study First Received: January 15, 2010
Results First Received: November 17, 2015
Last Updated: November 17, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on September 28, 2016