Status:
COMPLETED
A Study of Monthly Subcutaneous Continuous Erythropoietin Receptor Activator (CERA) in Predialysis Participants 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 long term maintenance of hemoglobin (Hb) levels, safety and tolerability of once monthly subcutaneous methoxy polyethylene glycol-epoetin beta (CERA) in predialys...
Eligibility Criteria
Inclusion
- Chronic renal anemia;
- Continuous subcutaneous maintenance darbopoetin alfa treatment during previous month;
- Hb concentration between 10 and 12 g/dL;
- Adequate iron status.
Exclusion
- Transfusion of red blood cells during previous 2 months;
- Significant acute or chronic bleeding, such as overt gastrointestinal bleeding;
- Poorly controlled hypertension requiring hospitalization or interruption of darbopoetin alfa treatment in the previous 6 months;
- Active malignant disease.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT00773968
Start Date
September 1 2008
End Date
March 1 2010
Last Update
April 4 2016
Active Locations (34)
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1
Barletta, Apulia, Italy, 70051
2
Molfetta (Ba), Apulia, Italy, 70056
3
Putignano, Apulia, Italy, 70017
4
Caserta, Campania, Italy, 81100