A Study of Once-Monthly Subcutaneous Mircera for the Treatment of Chronic Renal Anemia in Pre-Dialysis Patients Not Currently Treated With ESA.

November 4, 2013 updated by: Hoffmann-La Roche

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

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 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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, CP2700
      • La Plata, Argentina, 1900
      • Tucuman, Argentina, 4000
  • Brazil
      • Blumenau, Brazil, 89010-500
      • Botucatu, Brazil, 18618-000
      • Curitiba, Brazil, 80250-070
      • Rio de Janeiro, Brazil, 20551-030
      • Sao Paulo, Brazil, 01246-903
      • Sao Paulo, Brazil, 04039-901
  • Chile
      • Santiago, Chile, 8900000
      • Santiago de Chile, Chile, 056
  • Colombia
      • Barranquilla, Colombia, 575
      • Cali, Colombia, 572
      • Envigado, Colombia, 571
      • Medellin, Colombia
  • Costa Rica
      • San Jose, Costa Rica
  • Ecuador
      • Quito, Ecuador, 2569
  • Guatemala
      • Guatemala City, Guatemala
  • Panama
      • Panama City, Panama
  • Peru
      • Lima, Peru, L13
      • San Isidro, Peru, Lima 27
  • Venezuela
      • Caracas, Venezuela, 1020

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • chronic renal anemia;
  • no ESA therapy during previous 3 months;
  • adequate iron status;
  • rapid chronic kidney disease progression.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
sc every month (starting dose 1.2 micrograms/kg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean change in Hb concentration between baseline and Efficacy Evaluation Period (EEP).
Time Frame: Week 32
Week 32

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to achievement of response
Time Frame: Throughout study
Throughout study
Percentage of patients whose Hb concentration remains within range 10.0-12.0g/dL
Time Frame: Throughout study
Throughout study
Percentage of patients whose average Hb concentration is within range 10.0 - 12.0g/dL
Time Frame: Throughout study
Throughout study
Mean time spent in Hb range of 10.0 - 12.0g/dL
Time Frame: Throughout study
Throughout study
Percentage of patients requiring dose adjustments; incidence of RBC transfusions; time to initiation of renal replacement therapy.
Time Frame: Throughout study
Throughout study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

May 16, 2008

First Submitted That Met QC Criteria

May 16, 2008

First Posted (Estimate)

May 20, 2008

Study Record Updates

Last Update Posted (Estimate)

November 5, 2013

Last Update Submitted That Met QC Criteria

November 4, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML21467

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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