CompletedPhase 3

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

Netherlands20 participantsStarted 2008-03-27

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Percentage of Participants Maintaining Hb Concentration Within +/-1 Gram Per Deciliter (g/dL) of Their Reference Hb and Between 10.5 to 12.5 g/dL Throughout the Efficacy Evaluation Period (EEP)

Timeframe: EEP (Weeks 16 to 24)

Trial details

NCT IDNCT00642304

SponsorHoffmann-La Roche

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-12-09

Results submitted2016-09-16

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