Status:
COMPLETED
An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) as Maintenance Treatment in Patients With Chronic Renal Anemia on Haemodialysis
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Anemia, Kidney Disease, Chronic
Eligibility:
All Genders
18+ years
Brief Summary
This prospective observational study will evaluate the safety and efficacy of Mircera (methoxy polyethylene glycol-epoetin beta) in patients with chronic renal anemia on haemodialysis in maintenance E...
Eligibility Criteria
Inclusion
- Adult patients, \>/= 18 years of age
- Stage IV chronic kidney disease, on haemodialysis
- Chronic renal anemia, on maintenance ESA treatment
- Hemoglobin concentration between 10.0 an 12 g/dL
- Continuous maintenance epoetin therapy with the same dosing interval during the previous month
Exclusion
- Contraindications to ESA treatment (e.g. hypersensitivity, non-controlled hypertension)
- Hemoglobinopathies (e.g. homozygous sickle-cell disease, thalassemia of all types)
- Anemia due to hemolysis, pure red cell aplasia
Key Trial Info
Start Date :
June 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
185 Patients enrolled
Trial Details
Trial ID
NCT01422824
Start Date
June 1 2010
End Date
January 1 2014
Last Update
March 28 2016
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Delcevo, North Macedonia, 2320
2
Prilep, North Macedonia, 7500
3
Shtip, North Macedonia, 2000
4
Skopje, North Macedonia, 1000