CompletedPhase 3

A Study of Subcutaneous C.E.R.A. for the Treatment of Anemia in Pre-Dialysis Patients.

Russia133 participantsStarted 2008-05

Plain-language summary

This single arm study will assess the efficacy, safety and tolerability of subcutaneous C.E.R.A. for correction of anemia and maintenance of hemoglobin levels in patients with chronic kidney disease who are not on dialysis and are not treated with ESA. Eligible patients will receive C.E.R.A. by monthly subcutaneous injections, dependent on body weight (with a recommended starting dose of 1.2 micrograms/kg). The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

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: * adult patients, \>=18 years of age; * chronic renal anemia, with no need for dialysis expected in next 3 months; * adequate iron status. Exclusion Criteria: * previous epoetin therapy within 12 weeks prior to treatment; * transfusion of red blood cells during 2 months prior to screening; * significant acute or chronic bleeding such as overt gastrointestinal bleeding; * hemolysis; * folic acid and vitamin B 12 deficiency.

What they're measuring

Mean Change in Hb Concentration g/dL Between Baseline and the Efficacy Evaluation Period

Timeframe: Baseline (Week 0) and from Week 29 to Week 36

Trial details

NCT IDNCT00576628

SponsorHoffmann-La Roche

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-03

Results submitted2016-07-21

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