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

Primary Purpose

Anemia

Status
Completed
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
methoxy polyethylene glycol-epoetin beta
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • ASZ Aalst
  • ZNA Middelheim
  • ZNA Stuivenberg
  • AZ Sint Lucas Brugge
  • CH EpiCURA Site Ath
  • CH EpiCURA Site Louis Caty
  • Imeldaziekenhuis
  • UZ Brussel
  • Clinique Saint-Jean- Botanique
  • CHU Brugmann (Victor Horta)
  • Clin Univ de Bxl Hôpital Erasme
  • HIS (Joseph Bracops)
  • CHIREC Edith Cavell
  • Cliniques Universitaires St-Luc
  • CHU de Charleroi
  • AZ Sint Blasius (Dendermonde)
  • UZ Antwerpen
  • ZOL (Sint Jan)
  • AZ Sint Lucas (Sint Lucas)
  • UZ Gent
  • CH EpiCURA Site Hornu
  • CHR Hutois
  • Jan Yperman Onze Lieve Vrouw
  • UZ Leuven Gasthuisberg
  • Chr de La Citadelle
  • CHU Sart-Tilman
  • Clinique Saint-Joseph
  • AZ Delta (Campus Wilgenstraat)
  • AZ Nikolaas (Sint Niklaas)
  • CHWapi site IMC
  • AZ Turnhout Sint Jozef
  • CHR de Verviers - East Belgium

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Methoxy Polyethylene Glycol-Epoetin Beta

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change From Baseline in Hemoglobin Concentration to Efficacy Evaluation Period (EEP)
The mean change Baseline Hemoglobin to the time adjusted average of Hemoglobin during the EEP.
Percentage of Participants Maintaining Hemoglobin Concentrations Within Range of 10-12 Grams/Deciliter (g/dL) Throughout Efficacy Evaluation Period (EEP)
Mean Time Spent in Hemoglobin Range of 10-12 g/dL During Efficacy Evaluation Period (EEP)
Percentage of Participants With Adverse Events
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.

Full Information

First Posted
March 19, 2008
Last Updated
June 13, 2017
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT00642668
Brief Title
A Study of Subcutaneous Mircera for the Maintenance Treatment of Participants With Chronic Renal Anemia
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
June 30, 2008 (Actual)
Primary Completion Date
December 31, 2009 (Actual)
Study Completion Date
December 31, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Methoxy Polyethylene Glycol-Epoetin Beta
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
methoxy polyethylene glycol-epoetin beta
Other Intervention Name(s)
Mircera
Intervention Description
1.2 mcg/kg administered subcutaneously (sc) monthly for 36 weeks (initial recommended dose)
Primary Outcome Measure Information:
Title
Percentage of Participants Maintaining Average Hemoglobin Concentration During Efficacy Evaluation Period (EEP) Within Target Range
Description
The EEP was week 29 through week 36. The target range for average hemoglobin concentration was 10.0 - 12.0 g/dL.
Time Frame
Weeks 29-36
Secondary Outcome Measure Information:
Title
Change From Baseline in Hemoglobin Concentration to Efficacy Evaluation Period (EEP)
Description
The mean change Baseline Hemoglobin to the time adjusted average of Hemoglobin during the EEP.
Time Frame
Weeks 0-36
Title
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
Title
Mean Time Spent in Hemoglobin Range of 10-12 g/dL During Efficacy Evaluation Period (EEP)
Time Frame
Weeks 29-36
Title
Percentage of Participants With Adverse Events
Description
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.
Time Frame
Weeks 1-40

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
ASZ Aalst
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Facility Name
ZNA Middelheim
City
Antwerpen
ZIP/Postal Code
2020
Country
Belgium
Facility Name
ZNA Stuivenberg
City
Antwerpen
ZIP/Postal Code
2060
Country
Belgium
Facility Name
AZ Sint Lucas Brugge
City
Assebroek
ZIP/Postal Code
8310
Country
Belgium
Facility Name
CH EpiCURA Site Ath
City
Ath
ZIP/Postal Code
7800
Country
Belgium
Facility Name
CH EpiCURA Site Louis Caty
City
Baudour
ZIP/Postal Code
7331
Country
Belgium
Facility Name
Imeldaziekenhuis
City
Bonheiden
ZIP/Postal Code
2820
Country
Belgium
Facility Name
UZ Brussel
City
Brussel
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Clinique Saint-Jean- Botanique
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium
Facility Name
CHU Brugmann (Victor Horta)
City
Bruxelles
ZIP/Postal Code
1020
Country
Belgium
Facility Name
Clin Univ de Bxl Hôpital Erasme
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
Facility Name
HIS (Joseph Bracops)
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
Facility Name
CHIREC Edith Cavell
City
Bruxelles
ZIP/Postal Code
1180
Country
Belgium
Facility Name
Cliniques Universitaires St-Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
CHU de Charleroi
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
Facility Name
AZ Sint Blasius (Dendermonde)
City
Dendermonde
ZIP/Postal Code
9200
Country
Belgium
Facility Name
UZ Antwerpen
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
ZOL (Sint Jan)
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Facility Name
AZ Sint Lucas (Sint Lucas)
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
CH EpiCURA Site Hornu
City
Hornu
ZIP/Postal Code
7301
Country
Belgium
Facility Name
CHR Hutois
City
Huy
ZIP/Postal Code
4500
Country
Belgium
Facility Name
Jan Yperman Onze Lieve Vrouw
City
Ieper
ZIP/Postal Code
8900
Country
Belgium
Facility Name
UZ Leuven Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Chr de La Citadelle
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
CHU Sart-Tilman
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Clinique Saint-Joseph
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
AZ Delta (Campus Wilgenstraat)
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
AZ Nikolaas (Sint Niklaas)
City
Sint Niklaas
ZIP/Postal Code
9100
Country
Belgium
Facility Name
CHWapi site IMC
City
Tournai
ZIP/Postal Code
7500
Country
Belgium
Facility Name
AZ Turnhout Sint Jozef
City
Turnhout
ZIP/Postal Code
2300
Country
Belgium
Facility Name
CHR de Verviers - East Belgium
City
Verviers
ZIP/Postal Code
4800
Country
Belgium

12. IPD Sharing Statement

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

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