Status:
COMPLETED
A Study of Once Monthly Intravenous Mircera for the Maintenance Treatment of Dialysis Patients With Chronic Renal Anemia.
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Anemia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This single arm study will evaluate the maintenance of hemoglobin levels, safety and tolerability of once-monthly intravenous administration of Mircera in dialysis patients with chronic renal anemia. ...
Eligibility Criteria
Inclusion
- male or female patients, \>=18 years of age;
- chronic renal anemia;
- Hb concentration 10.5g/dL - 12.5g/dL;
- continuous intravenous maintenance therapy with epoetin alfa at the same dosing interval during the previous 2 months.
Exclusion
- blood transfusion within the previous 2 months;
- poorly controlled hypertension;
- significant acute or chronic bleeding;
- active malignant disease;
- congestive heart failure (NYHA Class IV).
Key Trial Info
Start Date :
August 26 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 12 2009
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT00737464
Start Date
August 26 2008
End Date
September 12 2009
Last Update
December 7 2017
Active Locations (17)
Enter a location and click search to find clinical trials sorted by distance.
1
Indraprastha Apollo Hospitals
New Delhi, National Capital Territory of Delhi, India, 110076
2
Manipal Institute of Nephrology and Urology; Nephrology
Bangalore, India, 560017
3
Columbia Asia Medical Centre - Hebbal; Nephrology
Bangalore, India, 560024
4
Tanker Foundation
Chennai, India, 600 037