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A Study of Monthly Subcutaneous Mircera for the Treatment of Chronic Renal Anemia in Predialysis Patients Not Treated With ESA.

NCT00661388 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2025-09-11

Study results available
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Summary

This single arm study will assess the efficacy and safety of subcutaneous methoxy polyethylene glycol-epoetin beta (Mircera) for the correction and maintenance of hemoglobin levels in predialysis patients with renal anemia who are not currently treated with erythropoietin stimulating agents (ESA). Eligible patients will receive monthly subcutaneous injections of Mircera 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.

Conditions

Interventions

DRUG

methoxy polyethylene glycol-epoetin beta [Mircera]

sc every month (starting dose 1.2 micrograms/kg)

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00661388 on ClinicalTrials.gov