Status:
COMPLETED
A Study of Two-Weekly Intravenous Mircera for the Treatment of Dialysis Patients With Chronic Renal Anemia Not Receiving ESA Therapy.
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Anemia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This single arm study will evaluate the hemoglobin (Hb) increasing effect, safety and tolerability of two-weekly intravenous administration of Mircera in dialysis patients with chronic renal anemia no...
Eligibility Criteria
Inclusion
- male or female patients, \>=18 years of age;
- chronic renal anemia (Hb concentration 8.0g/dL - 10.0g/dL);
- no prior erythropoietin stimulating agent (ESA) therapy.
Exclusion
- blood transfusion within the previous 4 weeks;
- poorly controlled hypertension;
- significant acute or chronic bleeding;
- active malignant disease;
- congestive heart failure (NYHA Class IV).
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
189 Patients enrolled
Trial Details
Trial ID
NCT00737711
Start Date
July 1 2008
End Date
October 1 2009
Last Update
June 2 2016
Active Locations (16)
Enter a location and click search to find clinical trials sorted by distance.
1
Ahmedabad, India, 380007
2
Bangalore, India, 560034
3
Chennai, India, 603103
4
Coimbatore, India, 641004