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

Phase 4

Completed

• Conditions: Anemia
• Interventions: Drug: methoxy polyethylene glycol-epoetin beta

• Registration Number: NCT00642668
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-03-19
• Study First Submitted QC: 2008-03-19
• Study First Posted: 2008-03-25
• Study Start: 2008-06-30
• Primary Completion: 2009-12-31
• Study Completion: 2009-12-31
• Results First Submitted: 2016-06-09
• Results First Submitted QC: 2016-06-09
• Results First Posted: 2016-07-22
• Status Verified: 2017-05
• Last Update Submitted: 2017-06-13
• Last Update Posted: 2017-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Methoxy Polyethylene Glycol-Epoetin Beta	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Maintaining Average Hemoglobin Concentration During Efficacy Evaluation Period (EEP) Within Target Range	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.

Secondary Outcome Measures

Name	Time	Method
Mean Time Spent in Hemoglobin Range of 10-12 g/dL During Efficacy Evaluation Period (EEP)	Weeks 29-36
Change From Baseline in Hemoglobin Concentration to Efficacy Evaluation Period (EEP)	Weeks 0-36	The mean change Baseline Hemoglobin to the time adjusted average of Hemoglobin during the EEP.
Percentage of Participants With Adverse Events	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.
Percentage of Participants Maintaining Hemoglobin Concentrations Within Range of 10-12 Grams/Deciliter (g/dL) Throughout Efficacy Evaluation Period (EEP)	Weeks 29-36

Trial Locations

Locations (32)

ASZ Aalst; 🇧🇪 Aalst, Belgium

ZNA Middelheim; 🇧🇪 Antwerpen, Belgium

ZNA Stuivenberg; 🇧🇪 Antwerpen, Belgium

AZ Sint Lucas Brugge; 🇧🇪 Assebroek, Belgium

CH EpiCURA Site Ath; 🇧🇪 Ath, Belgium

CH EpiCURA Site Louis Caty; 🇧🇪 Baudour, Belgium

Imeldaziekenhuis; 🇧🇪 Bonheiden, Belgium

UZ Brussel; 🇧🇪 Brussel, Belgium

Clinique Saint-Jean- Botanique; 🇧🇪 Bruxelles, Belgium

CHU Brugmann (Victor Horta); 🇧🇪 Bruxelles, Belgium

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