A Study of Subcutaneous Mircera for the Maintenance Treatment of Participants With Chronic Renal Anemia

NCT ID: NCT00642668

Last Updated: 2017-07-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2009-12-31

Brief Summary

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This single arm study assessed the efficacy and safety of subcutaneous methoxy polyethylene glycol-epoetin beta (Mircera), a continuous erythropoietin receptor activator (C.E.R.A.), for correction and/or maintenance of hemoglobin levels in participants with chronic kidney disease and renal anemia, who were not treated with erythropoiesis-stimulating agents (ESA) or on dialysis. Eligible participants received monthly subcutaneous injections of methoxy polyethylene glycol-epoetin beta at an initial recommended dose of 1.2 micrograms/kilogram (mcg/kg). The anticipated time on study treatment was 3-10 months, and the target sample size was 200 individuals.

Detailed Description

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Conditions

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Anemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Methoxy Polyethylene Glycol-Epoetin Beta

Participants received methoxy polyethylene glycol-epoetin beta treatment monthly for 36 weeks with an efficacy evaluation period (EEP) during weeks 29-36 and followed by a 4 week follow-up period.

Group Type EXPERIMENTAL

methoxy polyethylene glycol-epoetin beta

Intervention Type DRUG

1.2 mcg/kg administered subcutaneously (sc) monthly for 36 weeks (initial recommended dose)

Interventions

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methoxy polyethylene glycol-epoetin beta

1.2 mcg/kg administered subcutaneously (sc) monthly for 36 weeks (initial recommended dose)

Intervention Type DRUG

Other Intervention Names

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Mircera

Eligibility Criteria

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Inclusion Criteria

* Adult participants, \>=18 years of age;
* Chronic renal anemia;
* No ESA therapy during previous 3 months.

Exclusion Criteria

* Transfusion of red blood cells during previous 2 months;
* Poorly controlled hypertension requiring hospitalization in previous 6 months;
* Significant acute or chronic bleeding.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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UZ Leuven Gasthuisberg

Leuven, , Belgium

Site Status

Chr de La Citadelle

Liège, , Belgium

Site Status

CHU Sart-Tilman

Liège, , Belgium

Site Status

Clinique Saint-Joseph

Liège, , Belgium

Site Status

AZ Delta (Campus Wilgenstraat)

Roeselare, , Belgium

Site Status

AZ Nikolaas (Sint Niklaas)

Sint-Niklaas, , Belgium

Site Status

CHWapi site IMC

Tournai, , Belgium

Site Status

AZ Turnhout Sint Jozef

Turnhout, , Belgium

Site Status

CHR de Verviers - East Belgium

Verviers, , Belgium

Site Status

ZOL (Sint Jan)

Genk, , Belgium

Site Status

AZ Sint Lucas (Sint Lucas)

Ghent, , Belgium

Site Status

UZ Gent

Ghent, , Belgium

Site Status

CH EpiCURA Site Hornu

Hornu, , Belgium

Site Status

CHR Hutois

Huy, , Belgium

Site Status

Jan Yperman Onze Lieve Vrouw

Ieper, , Belgium

Site Status

ASZ Aalst

Aalst, , Belgium

Site Status

ZNA Middelheim

Antwerp, , Belgium

Site Status

ZNA Stuivenberg

Antwerp, , Belgium

Site Status

AZ Sint Lucas Brugge

Assebroek, , Belgium

Site Status

CH EpiCURA Site Ath

Ath, , Belgium

Site Status

CH EpiCURA Site Louis Caty

Baudour, , Belgium

Site Status

Imeldaziekenhuis

Bonheiden, , Belgium

Site Status

Clinique Saint-Jean- Botanique

Brussels, , Belgium

Site Status

CHU Brugmann (Victor Horta)

Brussels, , Belgium

Site Status

Clin Univ de Bxl Hôpital Erasme

Brussels, , Belgium

Site Status

HIS (Joseph Bracops)

Brussels, , Belgium

Site Status

UZ Brussel

Brussels, , Belgium

Site Status

CHIREC Edith Cavell

Brussels, , Belgium

Site Status

Cliniques Universitaires St-Luc

Brussels, , Belgium

Site Status

CHU de Charleroi

Charleroi, , Belgium

Site Status

AZ Sint Blasius (Dendermonde)

Dendermonde, , Belgium

Site Status

UZ Antwerpen

Edegem, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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ML21348

Identifier Type: -

Identifier Source: org_study_id

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