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

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®

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02238080
Acronym
IMPACT
Enrollment
197
Registered
2014-09-12
Start date
2009-12-31
Completion date
2012-06-30
Last updated
2017-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Diseases

Brief summary

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.

Interventions

DRUGMethoxy 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.

Sponsors

Hoffmann-La Roche
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Correlation Coefficient (r) Between Serum C-Reactive Protein (CRP) Level and Methoxy Polyethylene Glycol-Epoetin Beta DoseDay 1Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r).
Correlation Coefficient (r) Between Serum Interleukin-6 (IL-6) Level and Methoxy Polyethylene Glycol-Epoetin Beta DoseDay 1Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r).

Secondary

MeasureTime frameDescription
Serum CRP LevelBaseline, Month 6—
Serum IL-6 LevelBaseline, Month 6—
Correlation Coefficient (r) Between Serum CRP Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6Month 6Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r).
Percentage of Participants With Change in Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6Month 6Percentage 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).
Predictive Baseline Serum CRP Level for Participants Initiating Treatment With Methoxy Polyethylene Glycol-Epoetin Beta DoseDay 1—
Predictive Baseline Serum IL-6 Level for Participants Initiating Treatment With Methoxy Polyethylene Glycol-Epoetin Beta DoseDay 1—
Serum Hemoglobin LevelBaseline, Month 6—
Correlation Coefficient (r) Between Serum IL-6 Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6Month 6Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r).
Change From Baseline in Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6Baseline, Month 6—

Countries

Israel

Participant flow

Participants by arm

ArmCount
Methoxy Polyethylene Glycol-Epoetin Beta
Participants with anemia and CKD who were on dialysis therapy, and who initiated ESA treatment with methoxy polyethylene glycol-epoetin beta or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.
197
Total197

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyDeath13
Overall StudyOther4
Overall StudyTreatment interrupted6
Overall StudyWithdrawal by Subject2

Baseline characteristics

CharacteristicMethoxy Polyethylene Glycol-Epoetin Beta
Age, Continuous66.7 years
STANDARD_DEVIATION 12.3
Sex: Female, Male
Female
103 Participants
Sex: Female, Male
Male
94 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
15 / 197
serious
Total, serious adverse events
48 / 197

Outcome results

Primary

Correlation Coefficient (r) Between Serum C-Reactive Protein (CRP) Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose

Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r).

Time frame: Day 1

Population: ITT population. Participants with stable maintenance treatment were included in this analysis. 'Number of participants analyzed' (N) included participants evaluable for this outcome measure.

ArmMeasureValue (NUMBER)
Methoxy Polyethylene Glycol-Epoetin BetaCorrelation Coefficient (r) Between Serum C-Reactive Protein (CRP) Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose0.1485 correlation coefficient
Primary

Correlation Coefficient (r) Between Serum Interleukin-6 (IL-6) Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose

Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r).

Time frame: Day 1

Population: ITT population. Participants with stable maintenance treatment were included in this analysis. 'Number of participants analyzed' (N) included participants evaluable for this outcome measure.

ArmMeasureValue (NUMBER)
Methoxy Polyethylene Glycol-Epoetin BetaCorrelation Coefficient (r) Between Serum Interleukin-6 (IL-6) Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose0.05557 correlation coefficient
Secondary

Change From Baseline in Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6

Time frame: Baseline, Month 6

Population: ITT population. Participants with stable maintenance treatment were included in this analysis. 'Number of participants analyzed' (N) included participants evaluable for this outcome measure. 'Number analyzed' included participants evaluable for individual categories.

ArmMeasureGroupValue (MEAN)Dispersion
Methoxy Polyethylene Glycol-Epoetin BetaChange From Baseline in Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6Baseline175.2 mcg/kgStandard Deviation 109.8
Methoxy Polyethylene Glycol-Epoetin BetaChange From Baseline in Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6Change at Month 613.6 mcg/kgStandard Deviation 100.6
Secondary

Correlation Coefficient (r) Between Serum CRP Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6

Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r).

Time frame: Month 6

Population: ITT population. Participants with stable maintenance treatment were included in this analysis. 'Number of participants analyzed' (N) included participants evaluable for this outcome measure.

ArmMeasureValue (NUMBER)
Methoxy Polyethylene Glycol-Epoetin BetaCorrelation Coefficient (r) Between Serum CRP Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 60.12684 correlation coefficient
Secondary

Correlation Coefficient (r) Between Serum IL-6 Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6

Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r).

Time frame: Month 6

Population: ITT population. Participants with stable maintenance treatment were included in this analysis. 'Number of participants analyzed' (N) included participants evaluable for this outcome measure.

ArmMeasureValue (NUMBER)
Methoxy Polyethylene Glycol-Epoetin BetaCorrelation Coefficient (r) Between Serum IL-6 Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 60.19473 correlation coefficient
Secondary

Percentage of Participants With Change in Methoxy Polyethylene Glycol-Epoetin Beta Dose at 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).

Time frame: Month 6

Population: ITT population. Participants with stable maintenance treatment were included in this analysis.

ArmMeasureGroupValue (NUMBER)
Methoxy Polyethylene Glycol-Epoetin BetaPercentage of Participants With Change in Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6No change46.5 percentage of participants
Methoxy Polyethylene Glycol-Epoetin BetaPercentage of Participants With Change in Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6Dose increase29.9 percentage of participants
Methoxy Polyethylene Glycol-Epoetin BetaPercentage of Participants With Change in Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6Dose decrease23.5 percentage of participants
Secondary

Predictive Baseline Serum CRP Level for Participants Initiating Treatment With Methoxy Polyethylene Glycol-Epoetin Beta Dose

Time frame: Day 1

Population: As per change in planned analysis, this outcome was removed due to small sample size and no data was collected for this outcome.

Secondary

Predictive Baseline Serum IL-6 Level for Participants Initiating Treatment With Methoxy Polyethylene Glycol-Epoetin Beta Dose

Time frame: Day 1

Population: As per change in planned analysis, this outcome was removed due to small sample size and no data was collected for this outcome.

Secondary

Serum CRP Level

Time frame: Baseline, Month 6

Population: ITT population. Participants with stable maintenance treatment were included in this analysis. 'Number analyzed' included participants evaluable for individual categories.

ArmMeasureGroupValue (MEAN)Dispersion
Methoxy Polyethylene Glycol-Epoetin BetaSerum CRP LevelBaseline13.7 milligrams per liter (mg/L)Standard Deviation 18.7
Methoxy Polyethylene Glycol-Epoetin BetaSerum CRP LevelMonth 616.3 milligrams per liter (mg/L)Standard Deviation 29.3
Secondary

Serum Hemoglobin Level

Time frame: Baseline, Month 6

Population: ITT population. 'Number analyzed' included participants evaluable for individual categories.

ArmMeasureGroupValue (MEAN)Dispersion
Methoxy Polyethylene Glycol-Epoetin BetaSerum Hemoglobin LevelBaseline11.2 grams per deciliter (g/dL)Standard Deviation 1
Methoxy Polyethylene Glycol-Epoetin BetaSerum Hemoglobin LevelMonth 611.2 grams per deciliter (g/dL)Standard Deviation 1.4
Secondary

Serum IL-6 Level

Time frame: Baseline, Month 6

Population: ITT population. Participants with stable maintenance treatment were included in this analysis. 'Number analyzed' included participants evaluable for individual categories.

ArmMeasureGroupValue (MEAN)Dispersion
Methoxy Polyethylene Glycol-Epoetin BetaSerum IL-6 LevelBaseline15.8 picograms per milliliter (pg/mL)Standard Deviation 13.5
Methoxy Polyethylene Glycol-Epoetin BetaSerum IL-6 LevelMonth 616.7 picograms per milliliter (pg/mL)Standard Deviation 18.9

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026