An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) as Maintenance Treatment in Patients With Chronic Renal Anemia on Haemodialysis

This prospective observational study will evaluate the safety and efficacy of Mircera (methoxy polyethylene glycol-epoetin beta) in patients with chronic renal anemia on haemodialysis in maintenance ESA treatment. Data will be collected from patients receiving once monthly Mircera according to standard of care and local labelling during 12 months of treatment.

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Key information

Conditions

Anemia, Kidney Disease, Chronic Anemia Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Graft vs Host Disease Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Kidney Diseases Lung Diseases Lung Diseases, Obstructive Male Urogenital Diseases Organizing Pneumonia Respiratory Tract Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Delcevo, North Macedonia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adult patients, >/= 18 years of age
Stage IV chronic kidney disease, on haemodialysis
Chronic renal anemia, on maintenance ESA treatment
Hemoglobin concentration between 10.0 an 12 g/dL
Continuous maintenance epoetin therapy with the same dosing interval during the previous month

Exclusion criteria

Contraindications to ESA treatment (e.g. hypersensitivity, non-controlled hypertension)
Hemoglobinopathies (e.g. homozygous sickle-cell disease, thalassemia of all types)
Anemia due to hemolysis, pure red cell aplasia

Treatment and study plan

Primary outcomes

Number of Participants With Adverse Events (AEs)

Time frame: Up to 12 months

AE: any unfavorable and unintended sign, symptom, or disease associated with use of study drug, regardless of relation to study drug. Pre-existing conditions that worsened and laboratory or clinical tests that resulted in change in treatment or discontinuation from study drug were reported as AEs. Serious AE (SAE): resulted in death, life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was congenital anomaly/birth defect, or was medically significant. Any AE included participants with both serious and non-serious AEs.

Secondary outcomes

Hemoglobin Levels

Time frame: Baseline; Weeks 8, 16, 24, 48

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

An Observational. Non-interventional Study to Observe the Safety and Efficacy of MIRCERA in the Treatment of Chronic Renal Anemia in Maintenance ESA Treated Patients on Haemodialysis (STABILE)

Important dates

Study start: 2010
Primary completion: 2014
Study completion: 2014
First posted: Aug 24, 2011
Registry last updated: Mar 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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