CompletedPhase 3

A Study of Intravenous or Subcutaneous Mircera for the Treatment of Anemia in Dialysis Patients

United States336 participantsStarted 2004-06

Plain-language summary

This study will assess the efficacy and safety of intravenous (iv) or subcutaneous (sc) Mircera, administered with pre-filled syringes, as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv or sc epoetin. 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; * on dialysis therapy for at least 12 weeks before screening; * receiving iv or sc epoetin for at least 8 weeks before screening. Exclusion Criteria: * women who are pregnant, breastfeeding or using unreliable birth control methods; * administration of another investigational drug within 4 weeks before screening, or during the study period.

What they're measuring

Change in hemoglobin concentration

Timeframe: Weeks 1-36

Trial details

NCT IDNCT00081484

SponsorHoffmann-La Roche

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2006-03

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