A Study of Intravenous or Subcutaneous Methoxy Polyethylene Glycol-Epoetin Beta (RO0503821, Mircera) in Chronic Kidney Disease Patients With Renal Anemia

Completed · Phase 3

Conditions studied: Anemia

In brief

This study assessed the long-term efficacy, safety, and tolerability of intravenous (iv) or subcutaneous (sc) methoxy polyethylene glycol-epoetin beta in chronic kidney disease patients with renal anemia. Eligible patients were those who were receiving stable maintenance therapy with methoxy polyethylene glycol-epoetin beta or erythropoiesis stimulating agents (ESAs) in Phase II or III clinical studies. They continued to receive methoxy polyethylene glycol-epoetin beta or comparator ESAs at the same weekly dose and by the same route of administration (sc or iv) as in the qualifying studies.

Key facts

Study ID

NCT00090753

Run by

Hoffmann-La Roche

People needed

1228

Starts

2004-10-01

Expected to finish

2009-12-01

Last updated by the study team

2012-02-14

Who can join

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

You may qualify if…

• Written informed consent
• Adult patients (≥ 18 years old) with chronic renal anemia
• Maintenance erythropoietic therapy with methoxy polyethylene glycol-epoetin beta or a protocol-specified reference medication (epoetin alfa formulated with human albumin, epoetin beta or darbepoetin alfa) in one of the following studies: BA16528[NCT00048048], BA16285[NCT00048035], BA16286[NCT00364832], BA16736[NCT00077597], BA16738[NCT00081471], BA16739[NCT00077610], BA16740[NCT00077623], BA17283[NCT00077766] and BA17284[NCT00081484]
• Hemoglobin (Hb) concentration between 10.5 and 13.0 g/dL
• Adequate iron status defined as serum ferritin ≥ 100 ng/mL or Transferrin Saturation (TSAT)≥ 20% or percentage of hypochromic red blood cells (RBCs) < 10%

You may not qualify if…

• Poorly controlled hypertension
• History of epileptic seizure
• Pure red cell aplasia
• Chronic congestive heart failure [New York Heart Association (NYHA) IV]
• High likelihood of early withdrawal or interruption of the study
• Active malignant disease (except non-melanoma skin cancer)
• Life expectancy less than 12 months
• Pregnancy or breast-feeding

Where it is running

• Study site — Mobile, Alabama, United States
• Study site — Montgomery, Alabama, United States
• Study site — Hot Springs, Arkansas, United States
• Study site — Covina, California, United States
• Study site — Encino, California, United States
• Study site — Irvine, California, United States
• Study site — Los Alamitos, California, United States
• Study site — Los Angeles, California, United States
• Study site — Los Angeles, California, United States
• Study site — Monterey Park, California, United States
• Study site — Mountain View, California, United States
• Study site — Sacramento, California, United States
• Study site — San Diego, California, United States
• Study site — San Diego, California, United States
• Study site — San Francisco, California, United States
• Study site — Stanford, California, United States
• Study site — Colorado Springs, Colorado, United States
• Study site — Denver, Colorado, 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 — Atlanta, Georgia, United States
• Study site — Augusta, Georgia, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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