Status:

COMPLETED

A Study of Monthly Subcutaneous or Intravenous Mircera in Dialysis Patients With Chronic Renal Anaemia

Lead Sponsor:

Hoffmann-La Roche

Conditions:

Anemia

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief Summary

This open label, single arm study will assess the efficacy for long-term maintenance of haemoglobin levels and the safety and tolerability of methoxy polyethylene glycol-epoetin beta \[Mircera\] in di...

Eligibility Criteria

Inclusion

  • adult patients, \>/=18 years of age
  • chronic renal anaemia
  • haemoglobin 10.0-12.0g/dl at screening
  • adequate iron status
  • continuous stable ESA (erythropoietic stimulating agent) therapy for \>/= 2 months
  • regular haemodialysis or regular peritoneal dialysis for \>/= 3 months

Exclusion

  • uncontrolled hypertension
  • haemoglobinopathy
  • anaemia due to haemolysis
  • pure red cell aplasia (PRCA)

Key Trial Info

Start Date :

October 1 2010

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2013

Estimated Enrollment :

86 Patients enrolled

Trial Details

Trial ID

NCT01156363

Start Date

October 1 2010

End Date

January 1 2013

Last Update

December 3 2015

Active Locations (3)

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Page 1 of 1 (3 locations)

1

Kaohsiung City, Taiwan, 807

2

New Taiepei City, Taiwan

3

Taichung, Taiwan, 404