TerminatedPhase 3

A Study of Subcutaneous Mircera for the Treatment of Anemia in Pre-Dialysis Participants With Chronic Kidney Disease.

Stopped: Strategic decision unrelated to safety or efficacy

Estonia, Finland39 participantsStarted 2008-02

Plain-language summary

This single arm study will assess the efficacy and safety of subcutaneous Mircera for correction of anemia in participants with chronic kidney disease who are not on dialysis and are not treated with erythropoiesis-stimulating agents (ESA). Eligible participants will receive Mircera by monthly subcutaneous injections, dependent on body weight (with a starting dose of 1.2 micrograms/kilogram \[mcg/kg\]). 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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Inclusion Criteria: * chronic kidney disease, stage 3 or 4; * anemia (baseline hemoglobin between 9 and 11 grams per deciliter \[g/dL\]). Exclusion Criteria: * previous therapy with ESA within 12 weeks prior to screening; * significant acute or chronic bleeding such as overt gastrointestinal bleeding; * red blood cell transfusions within 8 weeks before screening; * active malignant disease (except non-melanoma skin cancer).

What they're measuring

Mean Change in Hemoglobin Concentration Between Baseline and the Efficacy Evaluation Period (EEP)

Timeframe: Baseline (Week -2 to 0) and EEP (Weeks 29 to 36)

Trial details

NCT IDNCT00462384

SponsorHoffmann-La Roche

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-04

Results submitted2016-03-02

View on ClinicalTrials.gov More Anemia trials