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

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: Completed
• Conditions: Chronic Kidney Diseases
• Intervention / Treatment: Drug: Methoxy Polyethylene Glycol-Epoetin Beta

• Study Type: Observational
• Enrollment (Actual): 197

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

Outcome Measure	Measure Description	Time Frame
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).	Day 1
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).	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Month 6
Change From Baseline in Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6		Baseline, Month 6
Serum CRP Level		Baseline, Month 6
Serum IL-6 Level		Baseline, Month 6
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).	Month 6
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).	Month 6
Predictive Baseline Serum CRP Level for Participants Initiating Treatment With Methoxy Polyethylene Glycol-Epoetin Beta Dose		Day 1
Predictive Baseline Serum IL-6 Level for Participants Initiating Treatment With Methoxy Polyethylene Glycol-Epoetin Beta Dose		Day 1
Serum Hemoglobin Level		Baseline, Month 6

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: September 10, 2014
• First Submitted That Met QC Criteria: September 10, 2014
• First Posted (Estimate): September 12, 2014

Study Record Updates

• Last Update Posted (Actual): May 15, 2017
• Last Update Submitted That Met QC Criteria: April 10, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Hematinics; Epoetin Alfa
• Other Study ID Numbers: ML22556