Completed

A Randomized, Open-label Study of the Effect of Intravenous Mircera on Hemoglobin Level/Correction in Dialysis Patients With Chronic Kidney Disease

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What is being tested

epoetin

+ methoxy polyethylene glycol-epoetin beta [Mircera]

Drug
Who is being recruted

Anemia

+ Hematologic Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: February 2004
See protocol details

Summary

Principal SponsorHoffmann-La Roche
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2004

Actual date on which the first participant was enrolled.

This study will assess the efficacy and safety of Mircera given intravenously in the treatment of renal anemia in chronic kidney disease patients on dialysis who are not currently receiving epoetin or any other erythropoietic substance. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.

Official TitleA Randomized, Open-label Study of the Effect of Intravenous Mircera on Hemoglobin Level/Correction in Dialysis Patients With Chronic Kidney Disease 
Principal SponsorHoffmann-La Roche
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

182 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AnemiaHematologic Diseases

Criteria

Inclusion Criteria: * adult patients \>=18 years of age; * chronic renal anemia; * dialysis therapy for at least 2 weeks before screening. Exclusion Criteria: * women who are pregnant, breastfeeding or using unreliable birth control methods; * administration of any investigational drug within 4 weeks before screening.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator

Group II

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has no location dataSave this study to your profile to know when the location data is available. 
CompletedNo study centers