Overview

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

Status:
Completed
Trial end date:
2009-12-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hoffmann-La Roche
Treatments:
Darbepoetin alfa
Epoetin Alfa
Criteria
Inclusion Criteria:

- 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%

Exclusion Criteria:

- 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