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A Study of Subcutaneous C.E.R.A. for the Maintenance of Hemoglobin Levels in Participants With Chronic Renal Anemia Not on Dialysis.

NCT00642304

CompletedPhase 3

Sponsor: Hoffmann-La Roche

Conditions: Anemia

Interventions: methoxy polyethylene glycol-epoetin beta [C.E.R.A.]

Countries: Netherlands

This single arm study will assess the efficacy and safety of subcutaneous C.E.R.A. when administered for the maintenance of hemoglobin levels in participants with chronic renal anemia, not on dialysis. Participants currently receiving maintenance treatment with subcutaneous darbepoetin alfa or epoetin beta will receive monthly injections of C.E.R.A., with the starting dose (120, 200 or 300 micrograms \[mcg\] subcutaneously \[SC\]) derived from the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding study start.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Chronic renal anemia
* Stable darbepoetin alfa or epoetin beta therapy for past 8 weeks

Exclusion Criteria:

* Transfusion of red blood cells during previous 8 weeks
* Poorly controlled hypertension requiring interruption of epoetin treatment in previous 6 months
* Acute or chronic bleeding requiring therapy within previous 8 weeks

Locations (23)

Almelo, Netherlands
Amersfoort, Netherlands
Amsterdam, Netherlands
Assen, Netherlands
Beverwijk, Netherlands
Breda, Netherlands
Delft, Netherlands
Doetinchem, Netherlands
Dordrecht, Netherlands
Drachten, Netherlands
Goes, Netherlands
Gouda, Netherlands
Heerlen, Netherlands
Hoogeveen, Netherlands
Leiden, Netherlands
Leiderdorp, Netherlands
Maastricht, Netherlands
Nijmegen, Netherlands
Rotterdam, Netherlands
Rotterdam, Netherlands
Rotterdam, Netherlands
Terneuzen, Netherlands
Utrecht, Netherlands