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A Study of Monthly Subcutaneous or Intravenous Mircera in Dialysis Patients With Chronic Renal Anaemia

NCT01156363 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2015-12-03

Study results available
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Summary

This open label, single arm study will assess the efficacy for long-term maintenance of haemoglobin levels and the safety and tolerability of methoxy polyethylene glycol-epoetin beta \[Mircera\] in dialysis patients with chronic renal anaemia. Patients on regular long-term haemodialysis or peritoneal dialysis will receive monthly subcutaneous or intravenous Mircera for 6 months. Target sample size is \<200 patients.

Conditions

Interventions

PROCEDURE

Dialysis

regular haemodialysis or peritoneal dialysis

DRUG

methoxy polyethylene glycol-epoetin beta [Mircera]

once monthly, subcutaneously or intravenously, for 32 weeks

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
2010-10-31
Primary Completion
2013-01-31
Completion
2013-01-31

Countries

  • Taiwan

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 NCT01156363 on ClinicalTrials.gov