A Study of Once Monthly Intravenous or Subcutaneous Mircera in Participants With Chronic Kidney Disease on Hemodialysis.

Anemia Clinical Trial

Official title:

A Randomised, Controlled, Open-label, French Multicenter Parallel Group Study to Compare the Maintenance of Haemoglobin Level With Once Monthly Administration of C.E.R.A. (Continuous Erythropoietin Receptor Activator) Versus Epoetin Beta or Darbepoetin Alfa in Patients With Chronic Kidney Disease on Haemodialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00717821
• Other study ID #: ML21145
• Status: Completed
• Phase: Phase 3
• Start date: August 2008
• Est. completion date: July 2011

Study information

• Verified date: September 2021
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This 2 arm study will compare the hemoglobin maintenance with once monthly methoxy polyethylene glycol-epoetin beta (Mircera) administration versus epoetin beta or darbepoetin alfa in participants with chronic kidney disease on hemodialysis. Participants will be randomized to receive either monthly intravenous (IV) or subcutaneous (SC) methoxy polyethylene glycol-epoetin beta (at a starting dose of 120 or 200 micrograms, calculated from the last weekly dose of epoetin beta or darbepoetin alfa previously administered), or standard therapy (IV or SC epoetin beta once, twice or thrice weekly, or IV or SC darbepoetin alfa once a week or twice a week).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 421
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• regular long term hemodialysis with same schedule for greater than or equal to (>=) 12 weeks

• continuous IV or SC maintenance epoetin beta or darbepoetin alfa therapy, with the same dosing interval during the previous month, and no change in total weekly dose

Exclusion Criteria:

• transfusion of red blood cells during previous 2 months

• significant acute or chronic bleeding

• poorly controlled hypertension requiring hospitalization or interruption of epoetin beta/darbepoetin alfa treatment in previous 6 months

• weekly dose of epoetin beta greater than (>) 16000 international units (IU), or weekly dose of darbepoetin alfa >80 micrograms during previous month

Related Conditions & MeSH terms

• Anemia
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Methoxy Polyethylene Glycol-epoetin Beta
Participants who are receiving SC or IV epoetin beta or darbepoetin alfa will receive monthly injections of methoxy polyethylene glycol-epoetin beta, with the starting dose of 120 or 200 micrograms calculated from the last weekly dose of epoetin beta or darbepoetin alfa previously administered, using the same route of administration (SC or IV). Thereafter, when the hemoglobin concentration will increase or decrease in a clinically significant amount, a dose adjustment will be performed according to specific provided guidance. Total duration of treatment will be up to 48 weeks.
• Epoetin Beta
Participants who are receiving SC or IV epoetin beta will continue to receive the treatment at the same dose, same administration intervals, and the same route of administration. When necessary, dose adjustments will be performed according to SmPC. Total duration of treatment will be up to 48 weeks.
• Darbepoetin Alfa
Participants who are receiving SC or IV darbepoetin alfa will continue to receive the treatment at the same dose, same administration intervals, and the same route of administration. When necessary, dose adjustments will be performed according to SmPC. Total duration of treatment will be up to 48 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients maintaining average Hb concentration within target range (10-12g/dL) during evaluation period.		Weeks 16-24
Secondary	Mean change in Hb concentration between reference and evaluation period, and mean time spent in Hb range of 10-12g/dL during evaluation period.		Weeks 16-24
Secondary	Dose adjustments, RBC transfusions, AEs.		Throughout study