CompletedPhase 2

A Study of Mircera in Anemic Patients With Chronic Kidney Disease Not Yet on Dialysis.

United States65 participantsStarted 2002-03

Plain-language summary

This study will evaluate the efficacy and safety of different subcutaneous starting doses and dosing frequencies of Mircera in anemic patients with chronic kidney disease not yet on dialysis. The anticipated time on study treatment is 3-12 months and the target sample size is \<100 individuals.

Who can participate

Age range18 Years

SexALL

See this in plain English?

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; * not receiving renal replacement therapy. Exclusion Criteria: * women who are pregnant, breastfeeding or using unreliable birth control methods; * administration of any investigational drug within 30 days preceding the screening visit and during the run-in period.

What they're measuring

The Change in Hemoglobin Over Time Between Baseline and End of Initial Treatment Based on Individual Regression Slopes

Timeframe: From Baseline (Day -28 to Day 1) to EOIT (Week 19)

Trial details

NCT IDNCT00048048

SponsorHoffmann-La Roche

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2003-10

Results submitted2016-10-26

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