Status:
COMPLETED
An Observational Study of Mircera (Methoxy Polyethylene Glycol-epoetin Beta) in Anemic Patients With Chronic Kidney Disease (NORM)
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Anemia
Eligibility:
All Genders
18+ years
Brief Summary
This observational, prospective, multi-centre, single-arm study will evaluate the efficacy of Mircera (methoxy polyethylene glycol-epoetin beta) in patients with chronic kidney disease previously on t...
Eligibility Criteria
Inclusion
- Adult patients, age 18 years or above
- Chronic kidney disease (CKD) with anemia
- Patients on dialysis receiving short-acting epoetin (EPO)
- Serum ferritin level \>/=100 ng/ml or transferrin saturation (TSAT) \>/=20%
Exclusion
- Patients unwilling to give informed consent
- Uncontrolled hypertension
- Transfusion of red blood cells within 8 weeks of the start of Mircera treatment
- Relevant acute or chronic bleeding history
- Hemolysis
- Hemoglobinopathies
- Pure red cell aplasia
Key Trial Info
Start Date :
May 31 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 31 2012
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01417377
Start Date
May 31 2010
End Date
March 31 2012
Last Update
July 13 2017
Active Locations (6)
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1
Sheikh Zayed Hospital; Department of Nephrology
Lahore, Pakistan, 20021
2
Fatima Memorial Hospital; Nephrology
Lahore, Pakistan, 54590
3
Doctor's Hospital and Medical Centre
Lahore, Pakistan
4
Khair-un-Nisa Hospital
Lahore, Pakistan