A Study of Once-Monthly Subcutaneous Mircera for the Treatment of Chronic Renal Anemia in Pre-Dialysis Patients Not Currently Treated With ESA.

An Open Label Study of the Safety, Tolerability and Effect on Hemoglobin Levels of Once-monthly Subcutaneous Mircera in Predialysis Patients With Chronic Renal Anemia Not Currently Treated With ESA.

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00680563

Enrollment

Registered

2008-05-20

Start date

2009-04-30

Completion date

2010-01-31

Last updated

2013-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia

Brief summary

This single arm study will assess the efficacy and safety of subcutaneous Mircera for the correction and maintenance of hemoglobin levels in predialysis patients with renal anemia who are not currently treated with ESA. Eligible patients will receive monthly subcutaneous injections at an initial recommended dose of 1.2 micrograms/kg. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Interventions

DRUGmethoxy polyethylene glycol-epoetin beta [Mircera]

sc every month (starting dose 1.2 micrograms/kg)

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* adult patients, \>=18 years of age; * chronic renal anemia; * no ESA therapy during previous 3 months; * adequate iron status; * rapid chronic kidney disease progression.

Exclusion criteria

* transfusion of red blood cells during previous 2 months; * poorly controlled hypertension requiring hospitalization in previous 6 months; * significant acute or chronic bleeding.

Design outcomes

Primary

Measure	Time frame
Mean change in Hb concentration between baseline and Efficacy Evaluation Period (EEP).	Week 32

Secondary

Measure	Time frame
Time to achievement of response	Throughout study
Percentage of patients whose Hb concentration remains within range 10.0-12.0g/dL	Throughout study
Percentage of patients whose average Hb concentration is within range 10.0 - 12.0g/dL	Throughout study
Mean time spent in Hb range of 10.0 - 12.0g/dL	Throughout study
Percentage of patients requiring dose adjustments; incidence of RBC transfusions; time to initiation of renal replacement therapy.	Throughout study

Countries

Argentina, Brazil, Chile, Colombia, Costa Rica, Ecuador, Guatemala, Panama, Peru, Venezuela

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026