Status:
COMPLETED
A Study of Intravenous or Subcutaneous Methoxy Polyethylene Glycol-Epoetin Beta (RO0503821, Mircera) in Chronic Kidney Disease Patients With Renal Anemia
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Anemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study assessed the long-term efficacy, safety, and tolerability of intravenous (iv) or subcutaneous (sc) methoxy polyethylene glycol-epoetin beta in chronic kidney disease patients with renal ane...
Eligibility Criteria
Inclusion
- Written informed consent
- Adult patients (≥ 18 years old) with chronic renal anemia
- Maintenance erythropoietic therapy with methoxy polyethylene glycol-epoetin beta or a protocol-specified reference medication (epoetin alfa formulated with human albumin, epoetin beta or darbepoetin alfa) in one of the following studies: BA16528\[NCT00048048\], BA16285\[NCT00048035\], BA16286\[NCT00364832\], BA16736\[NCT00077597\], BA16738\[NCT00081471\], BA16739\[NCT00077610\], BA16740\[NCT00077623\], BA17283\[NCT00077766\] and BA17284\[NCT00081484\]
- Hemoglobin (Hb) concentration between 10.5 and 13.0 g/dL
- Adequate iron status defined as serum ferritin ≥ 100 ng/mL or Transferrin Saturation (TSAT)≥ 20% or percentage of hypochromic red blood cells (RBCs) \< 10%
Exclusion
- Poorly controlled hypertension
- History of epileptic seizure
- Pure red cell aplasia
- Chronic congestive heart failure \[New York Heart Association (NYHA) IV\]
- High likelihood of early withdrawal or interruption of the study
- Active malignant disease (except non-melanoma skin cancer)
- Life expectancy less than 12 months
- Pregnancy or breast-feeding
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
1228 Patients enrolled
Trial Details
Trial ID
NCT00090753
Start Date
October 1 2004
End Date
December 1 2009
Last Update
February 14 2012
Active Locations (249)
Enter a location and click search to find clinical trials sorted by distance.
1
Birmingham, Alabama, United States, 35211
2
Mobile, Alabama, United States, 36608
3
Montgomery, Alabama, United States, 36106
4
Hot Springs, Arkansas, United States, 71901