An Observational Study of Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) in Chronic Kidney Disease Participants on Dialysis (IMPACT)

April 10, 2017 updated by: Hoffmann-La Roche

Inflammatory Markers and Mircera® Prospective Assessment of Correlation (IMPACT): A Multi-Center Observational Study Investigating the Correlation Between Inflammatory Marker Levels and ESA Dosage in CKD Patients on Dialysis Treated With Mircera®

This observational, multi-center, open-label, prospective study will evaluate the relationship between serum interleukin-6 (IL-6) and C-reactive protein (CRP) levels and methoxy polyethylene glycol-epoetin beta dosage in participants with chronic kidney disease (CKD) on dialysis. Participants will be recruited who are on stable methoxy polyethylene glycol-epoetin beta maintenance therapy or will initiate therapy with methoxy polyethylene glycol-epoetin beta.

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.
197

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

  • Israel
      • Afula, Israel, 18101
        • Haemek Hospital; Nephrology
      • Ashkelon, Israel, 78306
        • Barzilai Medical Centre ; Nephrology and Hypertension
      • Beer Sheva, Israel, 84101
        • Soroka Medical Center; Nephrology
      • Haifa, Israel, 31048
        • Bnai Zion MC; Nephrology
      • Haifa, Israel, 34362
        • Carmel Medical Center; Nephrology
      • Holon, Israel, 58100
        • Wolfson MC; Nephrology
      • Jerusalem, Israel, 91031
        • Shaare Zedek Medical Center; Nrphrology Dept.
      • Jerusalem, Israel, 91120
        • Hadassah Medical Orgainastion; Nephrology
      • Kfar Saba, Israel, 44281
        • Meir Medical Center; Nephrology Dept.
      • Nahariya, Israel, 22100
        • Western Galilee Hospital; Nrphrology Dept.
      • Nazareth, Israel, 16100
        • EMMS Nazareth; Nephrology
      • Nazareth, Israel, 16100
        • Holy Family Hospital; Nephrology
      • Petach Tikva, Israel, 49100
        • Beilinson Medical Center; Nephrology
      • Ramat-Gan, Israel, 52621
        • Sheba MC; Nephrology
      • Safed, Israel, 13100
        • Rebecca Sief Hospital; Nephrology
      • Tel Aviv, Israel, 6423906
        • Sourasky MC; Dept. of Nephrology
      • Tiberias, Israel
        • Poria Hospital; Nephrology
      • Zrifin, Israel, 70300
        • Assaf-Harofeh MC; Nephrology

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult participants with CKD on dialysis therapy, either initiating ESA treatment with methoxy polyethylene glycol-epoetin beta or on stable methoxy polyethylene glycol-epoetin beta maintenance therapy. The study is to be conducted in Israel.

Description

Inclusion Criteria:

  • CKD participants undergoing dialysis
  • Participants initiating ESA treatment with methoxy polyethylene glycol-epoetin beta or participants on stable methoxy polyethylene glycol-epoetin beta maintenance therapy
  • Adequate iron status defined as: serum ferritin above or equal to 100 micrograms per liter (mcg/L) or transferrin saturation above or equal to 20 percent (%)

Exclusion Criteria:

  • Conditions known to cause inadequate response to ESA treatment
  • Anemia other than symptomatic anemia associated with CKD

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

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.
Methoxy Polyethylene Glycol-Epoetin Beta
Participants with anemia and CKD who are on dialysis therapy, and who initiate erythropoiesis-stimulating agent (ESA) treatment with methoxy polyethylene glycol-epoetin beta or who are on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, will be treated according to the usual standard of care and current best practice guidelines, and will be observed during the study period.
Drug: Methoxy Polyethylene Glycol-Epoetin Beta
Methoxy polyethylene glycol-epoetin beta will be administered according to the usual standard of care and current best practice guidelines and will be observed during the study period.
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
Correlation Coefficient (r) Between Serum C-Reactive Protein (CRP) Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose
Time Frame: Day 1
Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r).
Day 1
Correlation Coefficient (r) Between Serum Interleukin-6 (IL-6) Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose
Time Frame: Day 1
Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r).
Day 1

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
Percentage of Participants With Change in Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6
Time Frame: Month 6
Percentage of participants with change in methoxy polyethylene glycol-epoetin beta dose compared to baseline were reported as per the following categories: (a) No change, (b) Dose increase (1 to greater than [>] 200 micrograms per kilogram [mcg/kg]), and (c) Dose decrease (1 to >200 mcg/kg).
Month 6
Change From Baseline in Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6
Time Frame: Baseline, Month 6
Baseline, Month 6
Serum CRP Level
Time Frame: Baseline, Month 6
Baseline, Month 6
Serum IL-6 Level
Time Frame: Baseline, Month 6
Baseline, Month 6
Correlation Coefficient (r) Between Serum CRP Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6
Time Frame: Month 6
Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r).
Month 6
Correlation Coefficient (r) Between Serum IL-6 Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6
Time Frame: Month 6
Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r).
Month 6
Predictive Baseline Serum CRP Level for Participants Initiating Treatment With Methoxy Polyethylene Glycol-Epoetin Beta Dose
Time Frame: Day 1
Day 1
Predictive Baseline Serum IL-6 Level for Participants Initiating Treatment With Methoxy Polyethylene Glycol-Epoetin Beta Dose
Time Frame: Day 1
Day 1
Serum Hemoglobin Level
Time Frame: Baseline, Month 6
Baseline, Month 6

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

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 1, 2009

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.
June 1, 2012

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.
June 1, 2012

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 10, 2014

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 10, 2014

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 12, 2014

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.
May 15, 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.
April 10, 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.
April 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.
  • ML22556

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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