Status:

COMPLETED

A Study of Once Monthly Subcutaneous Mircera in Dialysis Patients With Chronic Renal Anemia

Lead Sponsor:

Hoffmann-La Roche

Conditions:

Anemia

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

This single arm study will assess the efficacy, safety and tolerability of once monthly administration of subcutaneous Mircera for the maintenance of hemoglobin levels in dialysis patients with chroni...

Eligibility Criteria

Inclusion

  • adult patients \>=18 years of age;
  • chronic renal anemia;
  • regular long-term hemodialysis or peritoneal dialysis, with same mode of dialysis for \>=3 months;
  • continuous iv maintenance epoetin alfa therapy with same dosing interval during previous 2 months.

Exclusion

  • transfusion of red blood cells during previous 2 months;
  • poorly controlled hypertension;
  • significant acute or chronic bleeding;
  • active malignant disease (except non-melanoma skin cancer).

Key Trial Info

Start Date :

February 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 1 2010

Estimated Enrollment :

202 Patients enrolled

Trial Details

Trial ID

NCT00882713

Start Date

February 1 2009

End Date

October 1 2010

Last Update

October 7 2016

Active Locations (12)

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Page 1 of 3 (12 locations)

1

Agadir, Morocco, 70000

2

Casablanca, Morocco, 20000

3

Casablanca, Morocco, 20100

4

Casablanca, Morocco, 21000