A Study of Subcutaneous Mircera for the Maintenance Treatment of Participants With Chronic Renal Anemia
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)
1 other identifier
interventional
35
1 country
32
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jun 2008
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 19, 2008
CompletedFirst Posted
Study publicly available on registry
March 25, 2008
CompletedStudy Start
First participant enrolled
June 30, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2009
CompletedResults Posted
Study results publicly available
July 22, 2016
CompletedJuly 5, 2017
May 1, 2017
1.5 years
March 19, 2008
June 9, 2016
June 13, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Weeks 29-36
Secondary Outcomes (4)
Change From Baseline in Hemoglobin Concentration to Efficacy Evaluation Period (EEP)
Weeks 0-36
Percentage of Participants Maintaining Hemoglobin Concentrations Within Range of 10-12 Grams/Deciliter (g/dL) Throughout Efficacy Evaluation Period (EEP)
Weeks 29-36
Mean Time Spent in Hemoglobin Range of 10-12 g/dL During Efficacy Evaluation Period (EEP)
Weeks 29-36
Percentage of Participants With Adverse Events
Weeks 1-40
Study Arms (1)
Methoxy Polyethylene Glycol-Epoetin Beta
EXPERIMENTALParticipants 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.
Interventions
1.2 mcg/kg administered subcutaneously (sc) monthly for 36 weeks (initial recommended dose)
Eligibility Criteria
You may qualify if:
- Adult participants, \>=18 years of age;
- Chronic renal anemia;
- No ESA therapy during previous 3 months.
You may not qualify if:
- Transfusion of red blood cells during previous 2 months;
- Poorly controlled hypertension requiring hospitalization in previous 6 months;
- Significant acute or chronic bleeding.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
ASZ Aalst
Aalst, 9300, Belgium
ZNA Middelheim
Antwerp, 2020, Belgium
ZNA Stuivenberg
Antwerp, 2060, Belgium
AZ Sint Lucas Brugge
Assebroek, 8310, Belgium
CH EpiCURA Site Ath
Ath, 7800, Belgium
CH EpiCURA Site Louis Caty
Baudour, 7331, Belgium
Imeldaziekenhuis
Bonheiden, 2820, Belgium
Clinique Saint-Jean- Botanique
Brussels, 1000, Belgium
CHU Brugmann (Victor Horta)
Brussels, 1020, Belgium
Clin Univ de Bxl Hôpital Erasme
Brussels, 1070, Belgium
HIS (Joseph Bracops)
Brussels, 1070, Belgium
UZ Brussel
Brussels, 1090, Belgium
CHIREC Edith Cavell
Brussels, 1180, Belgium
Cliniques Universitaires St-Luc
Brussels, 1200, Belgium
CHU de Charleroi
Charleroi, 6000, Belgium
AZ Sint Blasius (Dendermonde)
Dendermonde, 9200, Belgium
UZ Antwerpen
Edegem, 2650, Belgium
ZOL (Sint Jan)
Genk, 3600, Belgium
AZ Sint Lucas (Sint Lucas)
Ghent, 9000, Belgium
UZ Gent
Ghent, 9000, Belgium
CH EpiCURA Site Hornu
Hornu, 7301, Belgium
CHR Hutois
Huy, 4500, Belgium
Jan Yperman Onze Lieve Vrouw
Ieper, 8900, Belgium
UZ Leuven Gasthuisberg
Leuven, 3000, Belgium
Chr de La Citadelle
Liège, 4000, Belgium
CHU Sart-Tilman
Liège, 4000, Belgium
Clinique Saint-Joseph
Liège, 4000, Belgium
AZ Delta (Campus Wilgenstraat)
Roeselare, 8800, Belgium
AZ Nikolaas (Sint Niklaas)
Sint-Niklaas, 9100, Belgium
CHWapi site IMC
Tournai, 7500, Belgium
AZ Turnhout Sint Jozef
Turnhout, 2300, Belgium
CHR de Verviers - East Belgium
Verviers, 4800, Belgium
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2008
First Posted
March 25, 2008
Study Start
June 30, 2008
Primary Completion
December 31, 2009
Study Completion
December 31, 2009
Last Updated
July 5, 2017
Results First Posted
July 22, 2016
Record last verified: 2017-05