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

CompletedPhase 2

Sponsor: Hoffmann-La Roche

Conditions: Anemia

Interventions: methoxy polyethylene glycol-epoetin beta [Mircera]

Countries: United States, Canada, Mexico, Poland, United Kingdom

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (15)

Birmingham, Alabama, United States
San Diego, California, United States
Detroit, Michigan, United States
Detroit, Michigan, United States
Las Vegas, Nevada, United States
Portland, Oregon, United States
Edmonton, Alberta, Canada
Vancouver, British Columbia, Canada
Mexico City, Mexico
Monterrey, Mexico
Gdansk, Poland
Krakow, Poland
Wroclaw, Poland
Belfast, United Kingdom
London, United Kingdom