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Register:	ClinicalTrials.gov
Last refreshed on:	16 December 2017
Main ID:	NCT02238080
Date of registration:	10/09/2014
Prospective Registration:	No
Primary sponsor:	Hoffmann-La Roche
Public title:	An Observational Study of Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) in Chronic Kidney Disease Participants on Dialysis IMPACT
Scientific 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®
Date of first enrolment:	December 2009
Target sample size:	197
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02238080
Study type:	Observational
Study design:
Phase:	N/A

Countries of recruitment
Israel

Contacts

Name:	Clinical Trials
Address:
Telephone:
Email:
Affiliation:	Hoffmann-La Roche

Key inclusion & exclusion criteria

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

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Kidney Diseases

Intervention(s)

Drug: Methoxy Polyethylene Glycol-Epoetin Beta

Primary Outcome(s)

Correlation Coefficient (r) Between Serum C-Reactive Protein (CRP) Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose [Time Frame: Day 1]

Correlation Coefficient (r) Between Serum Interleukin-6 (IL-6) Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose [Time Frame: Day 1]

Secondary Outcome(s)

Percentage of Participants With Change in Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6 [Time Frame: Month 6]

Serum CRP Level [Time Frame: Baseline, Month 6]

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

Serum IL-6 Level [Time Frame: Baseline, Month 6]

Change From Baseline in Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6 [Time Frame: Baseline, Month 6]

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

Predictive Baseline Serum CRP Level for Participants Initiating Treatment With Methoxy Polyethylene Glycol-Epoetin Beta Dose [Time Frame: Day 1]

Predictive Baseline Serum IL-6 Level for Participants Initiating Treatment With Methoxy Polyethylene Glycol-Epoetin Beta Dose [Time Frame: Day 1]

Serum Hemoglobin Level [Time Frame: Baseline, Month 6]

Secondary ID(s)

ML22556

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:	Yes
Date Posted:	06/04/2017
Date Completed:
URL:	https://clinicaltrials.gov/ct2/show/results/NCT02238080

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