Status:
COMPLETED
Study to Determine Optimum Intravenous Starting Dose of MIRCERA for Treatment of Pediatric Participants With Anemia and Chronic Kidney Disease on Hemodialysis
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Renal Anemia
Eligibility:
All Genders
5-17 years
Phase:
PHASE2
Brief Summary
This sequential study will assess the efficacy and safety of multiple doses of intravenous (IV) methoxy polyethylene glycol-epoetin beta (MIRCERA), and will determine the optimum starting dose for mai...
Eligibility Criteria
Inclusion
- Children aged 5-17 years (in Russia only: 12-17 years) with clinically stable chronic renal anemia
- Hemodialysis for greater than or equal to (\>=) 8 weeks
- Intravenous stable maintenance treatment with epoetin alfa, epoetin beta, or darbepoetin alfa for \>= 8 weeks before screening and with no weekly dose change \>= 25 percent (%) (increase or decrease) during the 2 weeks of screening
Exclusion
- Overt gastrointestinal bleeding within 8 weeks before screening or during the screening period
- Red blood cell (RBC) transfusions within 8 weeks before screening or during the screening period
- Active malignant disease
- Pure red cell aplasia (PRCA) or history of PRCA
- Pregnant or lactating females
- Sexually active participants: not willing to use reliable contraception during treatment and for 90 days following the end of treatment
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00717366
Start Date
July 1 2008
End Date
March 1 2016
Last Update
September 8 2017
Active Locations (39)
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1
Royal Children'S Hospital; Department of Nephrology
Parkville, Victoria, Australia, 3052
2
Hôpital Enfants Reine Fabiola
Brussels, Belgium, 1020
3
UZ Leuven Gasthuisberg
Leuven, Belgium, 3000
4
Hopital Femme Mere Enfant; Ped Nephrologie Rhumatologie
Bron, France, 69677