Clinical trial NCT00642668: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-03-25
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percentage of Participants Maintaining Average Hemoglobin Concentration During Efficacy Evaluation Period (EEP) Within Target Range
timeFrame: Weeks 29-36
Secondary outcomes:
measure: Change From Baseline in Hemoglobin Concentration to Efficacy Evaluation Period (EEP)
timeFrame: Weeks 0-36
measure: Percentage of Participants Maintaining Hemoglobin Concentrations Within Range of 10-12 Grams/Deciliter (g/dL) Throughout Efficacy Evaluation Period (EEP)
timeFrame: Weeks 29-36
measure: Mean Time Spent in Hemoglobin Range of 10-12 g/dL During Efficacy Evaluation Period (EEP)
timeFrame: Weeks 29-36
measure: Percentage of Participants With Adverse Events
timeFrame: Weeks 1-40
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: ASZ Aalst
city: Antwerpen
country: Belgium
facility: ZNA Middelheim
city: Antwerpen
country: Belgium
facility: ZNA Stuivenberg
city: Assebroek
country: Belgium
facility: AZ Sint Lucas Brugge
city: Ath
country: Belgium
facility: CH EpiCURA Site Ath
city: Baudour
country: Belgium
facility: CH EpiCURA Site Louis Caty
city: Bonheiden
country: Belgium
facility: Imeldaziekenhuis
city: Brussel
country: Belgium
facility: UZ Brussel
city: Bruxelles
country: Belgium
facility: Clinique Saint-Jean- Botanique
city: Bruxelles
country: Belgium
facility: CHU Brugmann (Victor Horta)
city: Bruxelles
country: Belgium
facility: Clin Univ de Bxl Hôpital Erasme
city: Bruxelles
country: Belgium
facility: HIS (Joseph Bracops)
city: Bruxelles
country: Belgium
facility: CHIREC Edith Cavell
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires St-Luc
city: Charleroi
country: Belgium
facility: CHU de Charleroi
city: Dendermonde
country: Belgium
facility: AZ Sint Blasius (Dendermonde)
city: Edegem
country: Belgium
facility: UZ Antwerpen
city: Genk
country: Belgium
facility: ZOL (Sint Jan)
city: Gent
country: Belgium
facility: AZ Sint Lucas (Sint Lucas)
city: Gent
country: Belgium
facility: UZ Gent
city: Hornu
country: Belgium
facility: CH EpiCURA Site Hornu
city: Huy
country: Belgium
facility: CHR Hutois
city: Ieper
country: Belgium
facility: Jan Yperman Onze Lieve Vrouw
city: Leuven
country: Belgium
facility: UZ Leuven Gasthuisberg
city: Liège
country: Belgium
facility: Chr de La Citadelle
city: Liège
country: Belgium
facility: CHU Sart-Tilman
city: Liège
country: Belgium
facility: Clinique Saint-Joseph
city: Roeselare
country: Belgium
facility: AZ Delta (Campus Wilgenstraat)
city: Sint Niklaas
country: Belgium
facility: AZ Nikolaas (Sint Niklaas)
city: Tournai
country: Belgium
facility: CHWapi site IMC
city: Turnhout
country: Belgium
facility: AZ Turnhout Sint Jozef
city: Verviers
country: Belgium
facility: CHR de Verviers - East Belgium
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: