A Study of Intravenous Mircera in Hemodialysis Patients With Chronic Renal Anemia

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

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

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-14

Study Completion Date

2010-06-22

Brief Summary

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

This single arm study will assess the efficacy, safety and tolerability of once-monthly administration of intravenous Mircera for the maintenance of hemoglobin levels in hemodialysis patients with chronic renal anemia. Patients will receive 4-weekly intravenous injections of Mircera, at a starting dose of 120, 200 or 360 micrograms. 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

NA

Intervention Model

SINGLE_GROUP

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.

C.E.R.A. 120, 200, or 360 mcg

Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (\<8000 IU, 8000-16000 IU, or \>16000 IU) or darbepoetin alpha (\<40 mcg, 40-80 mcg, or \>80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).

Group Type EXPERIMENTAL

methoxy polyethylene glycol-epoetin beta

Intervention Type DRUG

120, 200 or 360 micrograms iv every 4 weeks (starting dose)

Interventions

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

methoxy polyethylene glycol-epoetin beta

120, 200 or 360 micrograms iv every 4 weeks (starting dose)

Intervention Type DRUG

Eligibility Criteria

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

Inclusion Criteria

* adult patients, \>= 18 years of age;
* chronic renal anemia;
* continuous stable iv or sc maintenance epoetin therapy during previous 4 weeks;
* regular long-term hemodialysis therapy with the same mode of dialysis for previous 3 months.

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

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

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

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

Locatelli F, Choukroun G, Truman M, Wiggenhauser A, Fliser D. Once-Monthly Continuous Erythropoietin Receptor Activator (C.E.R.A.) in Patients with Hemodialysis-Dependent Chronic Kidney Disease: Pooled Data from Phase III Trials. Adv Ther. 2016 Apr;33(4):610-25. doi: 10.1007/s12325-016-0309-6. Epub 2016 Mar 10.

Reference Type DERIVED

PMID: 26965694 (View on PubMed)

Other Identifiers

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

ML21096

Identifier Type: -

Identifier Source: org_study_id

A Study of Intravenous Mircera in Hemodialysis Patients With Chronic Renal Anemia

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

C.E.R.A. 120, 200, or 360 mcg

methoxy polyethylene glycol-epoetin beta

Interventions

methoxy polyethylene glycol-epoetin beta

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Hoffmann-La Roche

Responsible Party

Principal Investigators

Clinical Trials

Locations

Cukurova University Medical Faculty; Internal Medicine

Ankara Research and Training Hospital; The Clinic of Nephrology

Ankara University School of Medicine; Nephrology

Faith University School of Medicine; Nephrology

Hacettepe University Medical Faculty; Department of Internal Medicine

Baskent University Hospital; Transplantation

Gazi University School of Medicine; Nephrology

Adnan Menderes Uni School of Medicine; Physical Therapy & Rehabilitation

Dicle Uni Medical Faculty; Internal Medicine

Trakya University Medical Faculty; Internal Medicine; Nephrology

Firat Uni School Of Medicine; Nephrology

Ataturk University Medical Faculty; Department of Internal Medicine

Sisli Etfal Research and Training Hospital; The Clinic of Nephrology

Istanbul University Istanbul Medical Faculty; Department of Internal Medicine

Marmara Uni School of Medicine; Nephrology

Izmir Ataturk Research and Training Hospital; The Clinic of Nephrology

Dokuz Eylul University School of Medicine; Nephrology

Erciyes University School of Medicine; Nephrology

Inonu Uni School of Medicine

Mersin University Medical Faculty

Countries

References

Other Identifiers

ML21096