Phase 3 N=1,228 Treatment

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

Anemia

Bottom Line

View on ClinicalTrials.gov: NCT00090753 ↗

Enrolled (actual)

1,228

Serious AEs

66.4%

Results posted

Jan 2012

Primary outcome: Primary: Change From Baseline in Hemoglobin Concentration to the Last Month of Study Participation — -0.55; -0.38 g/dL

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Methoxy Polyethylene Glycol-Epoetin Beta (Drug); Epoetin alfa (Drug); Epoetin beta (Drug); Darbepoetin alfa (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Hoffmann-La Roche
Primary completion: Dec 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Hemoglobin Concentration to the Last Month of Study Participation	-0.55; -0.38	—
SECONDARY Percentage of Patients Who Had at Least 1 Adverse Event	94.3; 93.3	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00090753). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.