Status:
TERMINATED
A Study of Subcutaneous Mircera for the Treatment of Anemia in Pre-Dialysis Participants With Chronic Kidney Disease.
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Anemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This single arm study will assess the efficacy and safety of subcutaneous Mircera for correction of anemia in participants with chronic kidney disease who are not on dialysis and are not treated with ...
Eligibility Criteria
Inclusion
- chronic kidney disease, stage 3 or 4;
- anemia (baseline hemoglobin between 9 and 11 grams per deciliter \[g/dL\]).
Exclusion
- previous therapy with ESA within 12 weeks prior to screening;
- significant acute or chronic bleeding such as overt gastrointestinal bleeding;
- red blood cell transfusions within 8 weeks before screening;
- active malignant disease (except non-melanoma skin cancer).
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00462384
Start Date
February 1 2008
End Date
April 1 2011
Last Update
April 1 2016
Active Locations (22)
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1
Tallinn, Estonia, 10617
2
Tallinn, Estonia, 13419
3
Tartu, Estonia, 51014
4
HUS, Finland, 00029