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

June 13, 2017 updated by: Hoffmann-La Roche

Subcutaneous Treatment of Anemia in Patients With a GFR Below 45 ml/Min/1.73m2 Through Injections With Mircera as Low Frequent as Once Monthly (STABILO)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 4

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

  • Belgium
      • Aalst, Belgium, 9300
        • ASZ Aalst
      • Antwerpen, Belgium, 2020
        • ZNA Middelheim
      • Antwerpen, Belgium, 2060
        • ZNA Stuivenberg
      • Assebroek, Belgium, 8310
        • AZ Sint Lucas Brugge
      • Ath, Belgium, 7800
        • CH EpiCURA Site Ath
      • Baudour, Belgium, 7331
        • CH EpiCURA Site Louis Caty
      • Bonheiden, Belgium, 2820
        • Imeldaziekenhuis
      • Brussel, Belgium, 1090
        • UZ Brussel
      • Bruxelles, Belgium, 1200
        • Cliniques Universitaires St-Luc
      • Bruxelles, Belgium, 1020
        • CHU Brugmann (Victor Horta)
      • Bruxelles, Belgium, 1070
        • Clin Univ de Bxl Hôpital Erasme
      • Bruxelles, Belgium, 1180
        • CHIREC Edith Cavell
      • Bruxelles, Belgium, 1000
        • Clinique Saint-Jean- Botanique
      • Bruxelles, Belgium, 1070
        • HIS (Joseph Bracops)
      • Charleroi, Belgium, 6000
        • CHU de Charleroi
      • Dendermonde, Belgium, 9200
        • AZ Sint Blasius (Dendermonde)
      • Edegem, Belgium, 2650
        • UZ Antwerpen
      • Genk, Belgium, 3600
        • ZOL (Sint Jan)
      • Gent, Belgium, 9000
        • UZ Gent
      • Gent, Belgium, 9000
        • AZ Sint Lucas (Sint Lucas)
      • Hornu, Belgium, 7301
        • CH EpiCURA Site Hornu
      • Huy, Belgium, 4500
        • CHR Hutois
      • Ieper, Belgium, 8900
        • Jan Yperman Onze Lieve Vrouw
      • Leuven, Belgium, 3000
        • UZ Leuven Gasthuisberg
      • Liège, Belgium, 4000
        • CHU Sart-Tilman
      • Liège, Belgium, 4000
        • CHR de la Citadelle
      • Liège, Belgium, 4000
        • Clinique Saint-Joseph
      • Roeselare, Belgium, 8800
        • AZ Delta (Campus Wilgenstraat)
      • Sint Niklaas, Belgium, 9100
        • AZ Nikolaas (Sint Niklaas)
      • Tournai, Belgium, 7500
        • CHWapi site IMC
      • Turnhout, Belgium, 2300
        • AZ Turnhout Sint Jozef
      • Verviers, Belgium, 4800
        • CHR de Verviers - East Belgium

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 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.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: methoxy polyethylene glycol-epoetin beta
1.2 mcg/kg administered subcutaneously (sc) monthly for 36 weeks (initial recommended dose)
Other Names:
  • Mircera

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Maintaining Average Hemoglobin Concentration During Efficacy Evaluation Period (EEP) Within Target Range
Time Frame: Weeks 29-36
The EEP was week 29 through week 36. The target range for average hemoglobin concentration was 10.0 - 12.0 g/dL.
Weeks 29-36

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Hemoglobin Concentration to Efficacy Evaluation Period (EEP)
Time Frame: Weeks 0-36
The mean change Baseline Hemoglobin to the time adjusted average of Hemoglobin during the EEP.
Weeks 0-36
Percentage of Participants Maintaining Hemoglobin Concentrations Within Range of 10-12 Grams/Deciliter (g/dL) Throughout Efficacy Evaluation Period (EEP)
Time Frame: Weeks 29-36
Weeks 29-36
Mean Time Spent in Hemoglobin Range of 10-12 g/dL During Efficacy Evaluation Period (EEP)
Time Frame: Weeks 29-36
Weeks 29-36
Percentage of Participants With Adverse Events
Time Frame: Weeks 1-40
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Weeks 1-40

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 (Actual)

June 30, 2008

Primary Completion (Actual)

December 31, 2009

Study Completion (Actual)

December 31, 2009

Study Registration Dates

First Submitted

March 19, 2008

First Submitted That Met QC Criteria

March 19, 2008

First Posted (Estimate)

March 25, 2008

Study Record Updates

Last Update Posted (Actual)

July 5, 2017

Last Update Submitted That Met QC Criteria

June 13, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML21348

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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