A Study of Intravenous Mircera in Dialysis Patients With Chronic Renal Disease and Anemia.

This study has been completed.

Sponsor:

Information provided by:

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT00576303

First received: December 18, 2007

Last updated: October 14, 2011

Last verified: October 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

December 18, 2007

Last Updated Date

October 14, 2011

Start Date ^ICMJE

February 2008

Primary Completion Date

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

Current Primary Outcome Measures ^ICMJE

Percentage of patients maintaining average Hb concentration within target range of 10.5-12.5g/L during evaluation period. [ Time Frame: Weeks 17-24 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Proportion of patients maintaining average Hb concentration within target range of 10.5-12.5g/dL during evaluation period (weeks 17-24).

Change History

Complete list of historical versions of study NCT00576303 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change in Hb concentration over evaluation period [ Time Frame: Weeks 17-24 ] [ Designated as safety issue: No ]
Percentage of patients maintaining Hb concentration in target range throughout evaluation period. [ Time Frame: Weeks 17-24 ] [ Designated as safety issue: No ]
Mean time spent in Hb target range; mean number of months/subject requiring dose adjustments; incidence of RBC transfusions. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Change in Hb conc. over evaluation period; % of patients maintaining Hb conc. in target range throughout evaluation period; mean time spent in Hb target range; mean no. of months/subject requiring dose adjustments; incidence of RBC transfusions.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Study of Intravenous Mircera in Dialysis Patients With Chronic Renal Disease and Anemia.

Official Title ^ICMJE

An Open Label Study to Assess the Maintenance of Haemoglobin Levels, Safety and Tolerability of Monthly Administration of Intravenous Mircera in Dialysis Patients With Chronic Renal Disease and Anaemia Who Are Currently Receiving Epoetin Alfa or Beta.

Brief Summary

This single arm study will assess the efficacy, safety and tolerability of monthly intravenous Mircera for the maintenance of hemoglobin levels in dialysis patients with chronic renal disease, currently receiving epoetin alfa or beta. Patients will receive monthly intravenous injections of Mircera at a starting dose of 120, 200 or 360 micrograms/month, depending on the dose of epoetin alfa or beta they were receiving in the week preceding study start. 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]

120, 200 or 360 micrograms iv monthly (starting dose)

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

200

Completion Date

April 2011

Primary Completion Date

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

Eligibility Criteria ^ICMJE

Inclusion Criteria:

adult patients, >=18 years of age;
chronic renal anemia;
hemodialysis or peritoneal dialysis, with same mode of dialysis for >=3 months before and throughout screening period;
continuous maintenance epoetin alfa or beta therapy with the same dosing interval during the previous 2 months.

Exclusion Criteria:

transfusion of red blood cells during previous 2 months;
poorly controlled hypertension requiring interruption of epoetin alfa or beta treatment in past 6 months;
significant acute or chronic bleeding such as overt gastrointestinal bleeding;
hemolysis;
folic acid and vitamin B12 deficiency.

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

Russian Federation

Administrative Information

NCT Number ^ICMJE

NCT00576303

Other Study ID Numbers ^ICMJE

ML20977

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

October 2011

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

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