A Study of Monthly Subcutaneous Mircera for the Treatment of Chronic Renal Anemia in Predialysis Patients Not Treated With ESA.

This study has been completed.

Sponsor:

Information provided by:

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT00661388

First received: April 16, 2008

Last updated: January 17, 2012

Last verified: January 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

April 16, 2008

Last Updated Date

January 17, 2012

Start Date ^ICMJE

August 2008

Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Mean change in Hb concentration between baseline and Efficacy Evaluation Period (EEP) [ Time Frame: Weeks 29-36 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00661388 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Time to achievement of response [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Percentage of patients whose Hb concentration remains within range 10.0-12.0 g/dL [ Time Frame: Weeks 29-36 ] [ Designated as safety issue: No ]
Percentage of patients whose average Hb concentration is within range 10.0-12.0 g/dL [ Time Frame: Weeks 29-36 ] [ Designated as safety issue: No ]
Mean time spent in Hb range of 10.0-12.0 g/dL [ Time Frame: Weeks 29-36 ] [ Designated as safety issue: No ]
Percentage of patients requiring dose adjustments; incidence of RBC transfusions. [ Time Frame: Weeks 0-36 ] [ Designated as safety issue: No ]
AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Time to achievement of response [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Percentage of patients whose Hb concentration remains within range 10.0-12.0 g/dL [ Time Frame: Weeks 29-36 ] [ Designated as safety issue: No ]
Percentage of patients whose average Hb concentration is within range 10.0-12.0 g/dL [ Time Frame: Weeks 29-36 ] [ Designated as safety issue: No ]
Mean time spent in Hb range of 10.0-12.0 g/dL [ Time Frame: Weeks 29-36 ] [ Designated as safety issue: No ]
Percentage of patients requiring dose adjustments; incidence of red blood cells (RBC) transfusions. [ Time Frame: Weeks 0-36 ] [ Designated as safety issue: No ]
AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Study of Monthly Subcutaneous Mircera for the Treatment of Chronic Renal Anemia in Predialysis Patients Not Treated With ESA.

Official Title ^ICMJE

An Open Label Study of the Safety, Tolerability and Effect on Hemoglobin Levels of Monthly Subcutaneous Mircera in Predialysis Patients With Chronic Renal Anemia Not Currently Treated With ESA.

Brief Summary

This single arm study will assess the efficacy and safety of subcutaneous Mircera for the correction and maintenance of hemoglobin levels in predialysis patients with renal anemia who are not currently treated with ESA. Eligible patients will receive monthly subcutaneous injections of Mircera at an initial recommended dose of 1.2 micrograms/kg. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Anemia

Intervention ^ICMJE

Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

sc every month (starting dose 1.2 micrograms/kg)

Study Arm (s)

Experimental: 1

Intervention: Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2011

Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

adult patients, >=18 years of age;
chronic renal anemia;
predialysis stage;
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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Turkey

Administrative Information

NCT Number ^ICMJE

NCT00661388

Other Study ID Numbers ^ICMJE

ML21524

Has Data Monitoring Committee

Not Provided

Responsible Party

Disclosures Group, Hoffmann-La Roche

Study Sponsor ^ICMJE

Hoffmann-La Roche

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Clinical Trials

Hoffmann-La Roche

Information Provided By

Hoffmann-La Roche

Verification Date

January 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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