Status:
COMPLETED
A Study of Monthly Subcutaneous (SC) Mircera for Maintenance Treatment of Participants With Chronic Kidney Disease on Peritoneal Dialysis
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Anemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This single-arm study will assess the efficacy and safety of monthly administration of SC Mircera for the maintenance of hemoglobin levels in participants with chronic kidney disease on peritoneal dia...
Eligibility Criteria
Inclusion
- Adults greater than or equal to (≥) 18 years of age
- Chronic kidney disease-related anemia on peritoneal dialysis for ≥3 months
- Continuous SC maintenance stable ESA therapy for 4 weeks prior to study start
Exclusion
- Transfusion of red blood cells during previous 8 weeks
- Poorly controlled hypertension requiring interruption of ESA treatment in previous 6 months
- Significant acute or chronic bleeding during previous 8 weeks
Key Trial Info
Start Date :
September 30 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2011
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT00737477
Start Date
September 30 2008
End Date
July 31 2011
Last Update
June 23 2017
Active Locations (52)
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1
Ch Notre Dame Misericorde; Hemodialyse
Ajaccio, France, 20303
2
Centre Hospitalier; Hemodialyse
Annonay, France, 07103
3
Ch D Arras; Nephrologie
Arras, France, 62022
4
Ch D Auxerre; Nephrologie Hemodialyse
Auxerre, France, 89011