An Observational Study to Evaluate the Effectiveness of Mircera Treatment for Renal Anemia in Pre-dialysis Participants With Chronic Kideny Disease (CKD)

May 9, 2017 updated by: Hoffmann-La Roche

Investigating the Effectiveness of Renal Anaemia Treatment in Pre-Dialysis Patients With Mircera in Daily Clinical Practice - MIRVITA

This observational trial will examine the efficacy and safety of Mircera for renal anemia in participants with stage III-IV CKD in daily clinical practice. Mircera will be prescribed by treating physician and followed for approximately 36 months.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
393

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovenia
      • Celje, Slovenia, 3000
        • Hospital Celje; Dept For Kidney Disease & Dialysis
      • Izola, Slovenia, 6310
        • Splosna Bolnisnica Izola; Oddelek Za Nefrologijo
      • Ljubljana, Slovenia, 1000
        • Clinical Centre Ljubljana; Clinical Dep. For Nephrology
      • Ljubljana, Slovenia, 1000
        • Nefroloska Ambulanta
      • Maribor, Slovenia, 2000
        • Hospital Maribor; Clinical Dept For Internal Medicine
      • Murska Sobota, Slovenia, 9000
        • Splosna Bolnisnica Murska Sobota; Oddelek Za Nefrologijo
      • Nova Gorica, Slovenia, 5000
        • Zdravstveni Zavod Medicinski Center Šinigoj Nova Gorica
      • Novo Mesto, Slovenia, 8000
        • Hospital Novo Mesto; Dialysis Dept
      • Ptuj, Slovenia, 2250
        • Hospital Dr.Joze Potre; Dialysis Dept
      • Sempeter Pri Novi Gorici, Slovenia, 5390
        • Splosna Bolnisnica Franc Derganc; Oddelek Za Nefrologijo
      • Slovenj Gradec, Slovenia, 2380
        • Hospital Slovenj Gradec; Hemodialysis Dept
      • Trbovlje, Slovenia, 1420
        • Splosna Bolnisnica Trbovlje; Oddelek Za Nefrologijo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants with CKD who do not require dialysis and are appropriate for treatment with Mircera according to European Best Practice Guidelines (EBPG) and Kidney Disease Outcomes Quality Initiative (K/DOQI) guidelines.

Description

Inclusion Criteria:

  • Participants aged > 18 years with CKD
  • Participants who are eligible for Mircera treatment according to current guidelines and summary of product characteristics (SmPC)

Exclusion Criteria:

  • Non-renal anemia
  • Pregnancy and breast-feeding
  • Uncontrolled hypertension
  • Known hypersensitivity to methoxy polyethylene glycol-epoetin beta
  • Administration of any other study drug within 30 days prior to study enrollment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
CKD participants treated with Mircera
Participants with CKD received Mircera, as per routine clinical practice and was followed for approximately 36 months.
Drug: Methoxy polyethylene glycol-epoetin beta
Other Names:
  • Mircera

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Hemoglobin (Hb) Value Within the Target Range (110 to 120 Grams Per Liter [g/L]) at Baseline
Time Frame: Baseline
If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Baseline
Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 1-3
Time Frame: At Months 1-3
If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
At Months 1-3
Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 4-6
Time Frame: At Months 4-6
If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
At Months 4-6
Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 7-9
Time Frame: At Months 7-9
If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
At Months 7-9
Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 10-12
Time Frame: At Months 10-12
If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
At Months 10-12
Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 13-15
Time Frame: At Months 13-15
If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
At Months 13-15
Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 16-18
Time Frame: At Months 16-18
If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
At Months 16-18
Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 19-21
Time Frame: At Months 19-21
If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
At Months 19-21
Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) After 21 Months up to 36 Months
Time Frame: After 21 Months up to 36 Months
If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
After 21 Months up to 36 Months
Percentage of Participants With Hemoglobin (Hb) Value Within the Target Range (100 to 130 g/L) at Baseline
Time Frame: At Baseline
If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
At Baseline
Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 1-3
Time Frame: At Months 1-3
If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
At Months 1-3
Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 4-6
Time Frame: At Months 4-6
If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
At Months 4-6
Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 7-9
Time Frame: At Months 7-9
If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
At Months 7-9
Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 10-12
Time Frame: At Months 10-12
If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
At Months 10-12
Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 13-15
Time Frame: At Months 13-15
If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
At Months 13-15
Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 16-18
Time Frame: At Months 16-18
If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
At Months 16-18
Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 19-21
Time Frame: At Months 19-21
If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
At Months 19-21
Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) After 21 Months up to 36 Months
Time Frame: After 21 Months up to 36 Months
If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
After 21 Months up to 36 Months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Median Time in Which Hb Value Was Maintained Within Target Range of 110-120 g/L
Time Frame: Up to 36 Months
Up to 36 Months
Median Time in Which Hb Value Was Maintained Within Target Range of 100-130 g/L
Time Frame: Up to 36 Months
Up to 36 Months
Average Dose of Methoxy Polyethylene Glycol-Epoetin Beta
Time Frame: Baseline
Average dose of methoxy polyethylene glycol-epoetin beta administered at Baseline
Baseline
Median Dose of Methoxy Polyethylene Glycol-Epoetin Beta
Time Frame: Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21 and After 21 Months up to 36 Months
Median monthly dose of methoxy polyethylene glycol-epoetin beta administered in the study up to 36 months.
Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21 and After 21 Months up to 36 Months
Number of Dose Adaptations
Time Frame: Up to 36 Months
Total number of changes (increase or decrease) in daily methoxy polyethylene glycol-epoetin beta doses. The reasons for dose-adaptations included: inflammation or infection; kidney function decline; over-response; iron deficiency; insufficient response; adverse effect; start of maintenance dose; kidney function improvement; re-introduction of treatment; and others (other reasons than specified).
Up to 36 Months
Percentage of Participants With Dose 0
Time Frame: Up to 36 Months
Percentage of participants who did not use methoxy polyethylene glycol-epoetin beta (Dose 0) at atleast one visit during study period.
Up to 36 Months
Percentage of Participants With Iron Replacement
Time Frame: Up to 36 Months
Iron replacement was given to the participants either in oral iron replacement or intravenous replacement or both.
Up to 36 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 31, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 9, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 11, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 7, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 9, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ML22069

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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