- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01422824
An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) as Maintenance Treatment in Patients With Chronic Renal Anemia on Haemodialysis
February 26, 2016 updated by: Hoffmann-La Roche
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)
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
185
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Delcevo, Macedonia, The Former Yugoslav Republic of, 2320
-
Prilep, Macedonia, The Former Yugoslav Republic of, 7500
-
Skopje, Macedonia, The Former Yugoslav Republic of, 1000
-
Stip, Macedonia, The Former Yugoslav Republic of, 2000
-
Struga, Macedonia, The Former Yugoslav Republic of, 6000
-
Strumica, Macedonia, The Former Yugoslav Republic of, 2400
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients with chronic renal anemia on haemodialysis in maintenance ESA treatment
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Cohort
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Hemoglobin Levels
Time Frame: Baseline; Weeks 8, 16, 24, 48
|
Baseline; Weeks 8, 16, 24, 48
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2010
Primary Completion (Actual)
January 1, 2014
Study Completion (Actual)
January 1, 2014
Study Registration Dates
First Submitted
August 23, 2011
First Submitted That Met QC Criteria
August 23, 2011
First Posted (Estimate)
August 24, 2011
Study Record Updates
Last Update Posted (Estimate)
March 28, 2016
Last Update Submitted That Met QC Criteria
February 26, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ML25067
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anemia, Kidney Disease, Chronic
-
Helwan UniversityCompletedAnemia of Chronic Kidney Disease | Chronic Renal Failure | Chronic Renal Failure AnemiaEgypt
-
Keryx BiopharmaceuticalsCompletedAnemia of Chronic Kidney DiseaseIsrael
-
Hoffmann-La RocheCompleted
-
Hoffmann-La RocheCompletedAnemia, Kidney Disease, ChronicGreece
-
Medical University of ViennaCompletedAnemia of Chronic Kidney DiseaseAustria
-
Dong-A ST Co., Ltd.UnknownAnemia of Chronic Kidney DiseaseTurkey
-
Chong Kun Dang PharmaceuticalCompletedAnemia of Chronic Kidney Disease
-
Jiangsu HengRui Medicine Co., Ltd.Enrolling by invitation
-
Rufaida MazahirCompletedAnemia of Chronic Kidney DiseaseIndia
-
Bio Sidus SAUnknownAnemia of Chronic Kidney DiseaseArgentina, Paraguay