Status:

COMPLETED

A Study of Intravenous or Subcutaneous Mircera for the Treatment of Anemia in Dialysis Patients

Lead Sponsor:

Hoffmann-La Roche

Conditions:

Anemia

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

This study will assess the efficacy and safety of intravenous (iv) or subcutaneous (sc) Mircera, administered with pre-filled syringes, as maintenance treatment for renal anemia in chronic kidney dise...

Eligibility Criteria

Inclusion

  • adult patients \>=18 years of age;
  • chronic renal anemia;
  • on dialysis therapy for at least 12 weeks before screening;
  • receiving iv or sc epoetin for at least 8 weeks before screening.

Exclusion

  • women who are pregnant, breastfeeding or using unreliable birth control methods;
  • administration of another investigational drug within 4 weeks before screening, or during the study period.

Key Trial Info

Start Date :

June 1 2004

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 1 2006

Estimated Enrollment :

336 Patients enrolled

Trial Details

Trial ID

NCT00081484

Start Date

June 1 2004

End Date

March 1 2006

Last Update

November 2 2016

Active Locations (66)

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Page 1 of 17 (66 locations)

1

Covina, California, United States, 91723

2

Los Alamitos, California, United States, 90720

3

Los Angeles, California, United States, 90073

4

San Diego, California, United States, 92123