Status:
COMPLETED
A Study of Intravenous Mircera in Hemodialysis 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 intravenous Mircera for the maintenance of hemoglobin levels in hemodialysis patients with chr...
Eligibility Criteria
Inclusion
- adult patients, \>= 18 years of age;
- chronic renal anemia;
- continuous stable iv or sc maintenance epoetin therapy during previous 4 weeks;
- regular long-term hemodialysis therapy with the same mode of dialysis for previous 3 months.
Exclusion
- transfusion of red blood cells during previous 2 months;
- poorly controlled hypertension requiring hospitalization or interruption of epoetin treatment in previous 6 months;
- significant acute or chronic bleeding.
Key Trial Info
Start Date :
May 14 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 22 2010
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT00661505
Start Date
May 14 2008
End Date
June 22 2010
Last Update
December 6 2017
Active Locations (20)
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1
Cukurova University Medical Faculty; Internal Medicine
Adana, Turkey (Türkiye), 01330
2
Ankara Research and Training Hospital; The Clinic of Nephrology
Ankara, Turkey (Türkiye), 06100
3
Ankara University School of Medicine; Nephrology
Ankara, Turkey (Türkiye), 06100
4
Faith University School of Medicine; Nephrology
Ankara, Turkey (Türkiye), 06100