CompletedPhase 4

A Study of Once Monthly Subcutaneous Mircera in Patients With Chronic Renal Anemia Not on Dialysis

South Korea191 participantsStarted 2009-04-30

Plain-language summary

This single arm study will assess the efficacy, safety and tolerability of once monthly administration of subcutaneous Mircera for the maintenance of hemoglobin levels in patients with chronic renal anemia not on dialysis.Patients will receive sc Mircera at a starting dose of 100, 120, 200 or 360 micrograms every 4 weeks, calculated from the last weekly dose of ESA previously administered. Subsequent doses will be adjusted to maintain hemoglobin levels within the target range. 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; * continuous maintenance ESA therapy with the same dosing interval during the previous month, and no change in totally weekly dose. Exclusion Criteria: * transfusion of red blood cells during previous 2 months; * poorly controlled hypertension; * significant acute or chronic bleeding; * active malignant disease (except non-melanoma skin cancer).

What they're measuring

Percentage of Participants Maintaining Average Hemoglobin Concentration Within the Target Range During the Efficacy Evaluable Period (EEP)

Timeframe: EEP (Weeks 17 to 24)

Trial details

NCT IDNCT00922116

SponsorHoffmann-La Roche

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-11-30

Results submitted2015-11-04

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