A Study of Subcutaneous Mircera for the Treatment of Anemia in Peritoneal Dialysis Patients.

Stopped early · Phase 3

Conditions studied: Anemia

In brief

This 2 arm study will compare the efficacy of monthly Mircera and epoetin alfa in peritoneal dialysis patients who self-inject at home or receive in-centre injections. The safety of subcutaneous (sc) Mircera and injection site reactions and patient satisfaction will also be assessed. Eligible patients will be randomized either to receive monthly sc injections of Mircera (and will be switched from sc epoetin alfa) at a starting dose of 120-360 micrograms, or to remain on standard of care sc epoetin alfa. Dose adjustments will be permitted to reach/maintain a hemoglobin level of 10-12g/dL. The anticipated time on study treatment is 3-12 months, and the target sample size is 380 individuals.

Key facts

Study ID

NCT00442416

Run by

Hoffmann-La Roche

People needed

80

Starts

2007-02-01

Expected to finish

2008-01-01

Last updated by the study team

2016-08-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• adult patients, >=18 years of age;
• chronic kidney disease stage V;
• on peritoneal dialysis for 3 months prior to screening;
• on epoetin alfa sc >=3 months prior to screening.

You may not qualify if…

• patients expecting to change dialysis modality over course of study;
• patients hospitalized during previous 3 months for any clinically significant condition;
• active malignancy;
• bleeding episode necessitating transfusion, or overt gastrointestinal bleeding within 3 months prior to screening;
• transfusion of red blood cells within 3 months prior to screening.

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Bakersfield, California, United States
• Study site — Chula Vista, California, United States
• Study site — Mountain View, California, United States
• Study site — San Leandro, California, United States
• Study site — Simi Valley, California, United States
• Study site — Whittier, California, United States
• Study site — Lakewood, Colorado, United States
• Study site — Stamford, Connecticut, United States
• Study site — Ocala, Florida, United States
• Study site — Pembroke Pines, Florida, United States
• Study site — Augusta, Georgia, United States
• Study site — Marietta, Georgia, United States
• Study site — Wichita, Kansas, United States
• Study site — Detroit, Michigan, United States
• Study site — Pontiac, Michigan, United States
• Study site — Flushing, New York, United States
• Study site — Syracuse, New York, United States
• Study site — Williamsville, New York, United States
• Study site — Dayton, Ohio, United States
• Study site — Toledo, Ohio, United States
• Study site — Tulsa, Oklahoma, United States
• Study site — Lewistown, Pennsylvania, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Dyersburg, Tennessee, United States

Full record on ClinicalTrials.gov

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