MedDataX Logo

A Study Comparing Maintenance of Hemoglobin Levels, Safety and Tolerability of Once Every 4 Weeks Mircera Versus Epoetin Beta in Dialysis Patients With Chronic Renal Anemia.

NCT ID: NCT00773331

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

281 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2010-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This two arm study will compare the maintenance of hemoglobin levels, safety and tolerability of once every 4 weeks subcutaneous administration of Mircera versus epoetin beta in dialysis patients with chronic renal anemia. Patients will be randomized to receive either subcutaneous Mircera (starting dose 120, 200 or 360 micrograms) every 4 weeks or subcutaneous epoetin beta in accordance with the prescribed dosing information. In both groups, the starting dose will be the same as the previous dose of epoetin beta administered in the week preceding first study drug administration. Patients will be treated for 28 weeks with follow up 4 weeks after the last treatment visit. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Group Type EXPERIMENTAL

methoxy polyethylene glycol-epoetin beta [Mircera]

Intervention Type DRUG

120, 200 or 360 micrograms every 4 weeks

2

Group Type ACTIVE_COMPARATOR

epoetin beta

Intervention Type DRUG

As prescribed

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

epoetin beta

As prescribed

Intervention Type DRUG

methoxy polyethylene glycol-epoetin beta [Mircera]

120, 200 or 360 micrograms every 4 weeks

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* male or female patients, \>=18 years of age;
* chronic renal anemia;
* Hb concentration 10.0 - 12.0 g/dL during the screening period;
* continuous subcutaneous maintenance therapy with epoetin at the same dose AND same dosing interval for at least 12 weeks before and throughout screening.

Exclusion Criteria

* blood transfusion within the previous 8 weeks;
* poorly controlled hypertension;
* significant or acute or chronic bleeding;
* active malignant disease;
* congestive heart failure (NYHA Class IV).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Beijing, , China

Site Status

Beijing, , China

Site Status

Beijing, , China

Site Status

Beijing, , China

Site Status

Beijing, , China

Site Status

Chengdu, , China

Site Status

Guangzhou, , China

Site Status

Guangzhou, , China

Site Status

Hangzhou, , China

Site Status

Nanjing, , China

Site Status

Nanjing, , China

Site Status

Shanghai, , China

Site Status

Shanghai, , China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ML21904

Identifier Type: -

Identifier Source: org_study_id