Status:

COMPLETED

A Study of NeoRecormon (Epoetin Beta) in Patients With End Stage Renal Disease.

Lead Sponsor:

Hoffmann-La Roche

Conditions:

Anemia

Eligibility:

All Genders

18-75 years

Phase:

PHASE4

Brief Summary

This single arm study will determine the effects of complete anemia correction in anemic patients with end-stage renal disease currently receiving suboptimal doses of NeoRecormon. Patients on dialysis...

Eligibility Criteria

Inclusion

  • adult patients, 18-75 years of age;
  • end-stage renal disease;
  • on renal dialysis \>= 3 months;
  • receiving NeoRecormon treatment \>= 3 months;
  • Hb stable and \<105g/L, and LVMI \>160g/m2.

Exclusion

  • unstable hypertension, myocardial infarction, unstable angina pectoris or risk of deep vein thrombosis in last 6 months;
  • use of any ESA other than NeoRecormon;
  • acute infection;
  • use of iv NeoRecormon.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 1 2008

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT00413101

End Date

March 1 2008

Last Update

May 14 2009

Active Locations (1)

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1

Novi Sad, Serbia, 21000