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

Chronic Kidney Diseases Clinical Trial

— IMPACT  

Official title:

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®

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02238080
• Other study ID #: ML22556
• Status: Completed
• Phase: N/A
• First received: September 10, 2014
• Last updated: February 6, 2017
• Start date: December 2009
• Est. completion date: June 2012

Study information

• Verified date: February 2017
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 197
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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.

Locations

Country	Name	City	State
Israel	Haemek Hospital; Nephrology	Afula
Israel	Soroka Medical Center; Nephrology	Beer Sheva
Israel	Wolfson MC; Nephrology	Holon
Israel	Hadassah Medical Orgainastion; Nephrology	Jerusalem
Israel	EMMS Nazareth; Nephrology	Nazareth
Israel	Holy Family Hospital; Nephrology	Nazareth
Israel	Beilinson Medical Center; Nephrology	Petach Tikva
Israel	Rebecca Sief Hospital; Nephrology	Safed
Israel	Sourasky MC; Dept. of Nephrology	Tel Aviv
Israel	Poria Hospital; Nephrology	Tiberias
Israel	Assaf-Harofeh MC; Nephrology	Zrifin

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation Coefficient (r) Between Serum C-Reactive Protein (CRP) Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose	Regression analysis and Pearson correlation will be used to calculate the correlation coefficient (r).	Day 1
Primary	Correlation Coefficient (r) Between Serum Interleukin-6 (IL-6) Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose	Regression analysis and Pearson correlation will be used to calculate the correlation coefficient (r).	Day 1
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 will be 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
Secondary	Change from Baseline in Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6		Baseline, Month 6
Secondary	Serum CRP Level		Baseline, Month 6
Secondary	Serum IL-6 Level		Baseline, Month 6
Secondary	Correlation Coefficient (r) Between Serum CRP Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6	Regression analysis and Pearson correlation will be used to calculate the correlation coefficient (r).	Month 6
Secondary	Correlation Coefficient (r) Between Serum IL-6 Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6		Month 6
Secondary	Predictive Baseline Serum CRP Level for Participants Initiating Treatment with Methoxy Polyethylene Glycol-Epoetin Beta Dose		Day 1
Secondary	Predictive Baseline Serum IL-6 Level for Participants Initiating Treatment with Methoxy Polyethylene Glycol-Epoetin Beta Dose		Day 1
Secondary	Serum Hemoglobin Level		Baseline, Month 6