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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01422824
First received: August 23, 2011
Last updated: February 26, 2016
Last verified: February 2016
  Purpose
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.

Condition
Anemia, Kidney Disease, Chronic

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official 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)

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Number of Participants With Adverse Events (AEs) [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Hemoglobin Levels [ Time Frame: Baseline; Weeks 8, 16, 24, 48 ] [ Designated as safety issue: No ]

Enrollment: 185
Study Start Date: June 2010
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with chronic renal anemia on haemodialysis in maintenance ESA treatment
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01422824

Locations
Macedonia, The Former Yugoslav Republic of
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
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01422824     History of Changes
Other Study ID Numbers: ML25067 
Study First Received: August 23, 2011
Results First Received: February 26, 2016
Last Updated: February 26, 2016
Health Authority: Macedonia: Ministry of Health

Additional relevant MeSH terms:
Anemia
Kidney Diseases
Chronic Disease
Renal Insufficiency, Chronic
Hematologic Diseases
Urologic Diseases
Disease Attributes
Pathologic Processes
Renal Insufficiency

ClinicalTrials.gov processed this record on September 23, 2016