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

NCT01422824 | Completed Results

• 1 other identifier: ML25067
• Study Type: observational
• Target: 185
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Anemia, Kidney Disease, Chronic

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events (AEs)

  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 Outcomes (1)

• Hemoglobin Levels

  Baseline; Weeks 8, 16, 24, 48

Study Arms (1)

Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with chronic renal anemia on haemodialysis in maintenance ESA treatment

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (6)

Unknown Facility

Delcevo, 2320, North Macedonia

Location

Unknown Facility

Prilep, 7500, North Macedonia

Location

Unknown Facility

Shtip, 2000, North Macedonia

Location

Unknown Facility

Skopje, 1000, North Macedonia

Location

Unknown Facility

Struga, 6000, North Macedonia

Location

Unknown Facility

Strumica, 2400, North Macedonia

Location

MeSH Terms

Conditions

Anemia; Kidney Diseases; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-LaRoche

genentech@druginfo.com

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2011
• First Posted: August 24, 2011
• Study Start: June 1, 2010
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: March 28, 2016
• Results First Posted: March 28, 2016

Record last verified: 2016-02

Locations

NO (6)