Status:

COMPLETED

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

Lead Sponsor:

Hoffmann-La Roche

Conditions:

Chronic Kidney Diseases

Eligibility:

All Genders

18+ years

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-ep...

Eligibility Criteria

Inclusion

  • 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

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

Key Trial Info

Start Date :

December 1 2009

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

June 1 2012

Estimated Enrollment :

197 Patients enrolled

Trial Details

Trial ID

NCT02238080

Start Date

December 1 2009

End Date

June 1 2012

Last Update

May 15 2017

Active Locations (18)

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Page 1 of 5 (18 locations)

1

Haemek Hospital; Nephrology

Afula, Israel, 18101

2

Barzilai Medical Centre ; Nephrology and Hypertension

Ashkelon, Israel, 78306

3

Soroka Medical Center; Nephrology

Beersheba, Israel, 84101

4

Bnai Zion MC; Nephrology

Haifa, Israel, 31048