Status:

COMPLETED

A Study of Once Monthly Subcutaneous Mircera in Patients With Chronic Renal Anemia Not on Dialysis

Lead Sponsor:

Hoffmann-La Roche

Conditions:

Anemia

Eligibility:

All Genders

18+ years

Phase:

PHASE4

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 patients with chronic renal a...

Eligibility Criteria

Inclusion

  • adult patients, \>=18 years of age;
  • chronic renal anemia;
  • continuous maintenance ESA therapy with the same dosing interval during the previous month, and no change in totally weekly dose.

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 :

April 30 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 30 2010

Estimated Enrollment :

191 Patients enrolled

Trial Details

Trial ID

NCT00922116

Start Date

April 30 2009

End Date

November 30 2010

Last Update

July 13 2017

Active Locations (10)

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Page 1 of 3 (10 locations)

1

Inje University Busan Paik Hospital; Nephrology

Busan, South Korea, 633-165

2

Kyungpook National Uni Hospital; Internal Medicine

Daegu, South Korea, 700-721

3

Chungnam National Uni Hospital; Nephrology

Daejeon, South Korea, 301-721

4

Chonnam National University Hospital

Gwangju, South Korea, 61469