Observational Study to Investigate the Long-term Effects of MIRCERA in Clinical Routine

Anemia Clinical Trial

Official title:

Non-interventional Study to Investigate the Long Term Effects of MIRCERA in Clinical Routine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01309269
• Other study ID #: ML22911
• Status: Completed
• Phase: N/A
• First received: March 3, 2011
• Last updated: November 1, 2016
• Start date: September 2010
• Est. completion date: April 2014

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Bundesinstitut für Arzneimittel und Medizinprodukte
• Study type: Observational

Clinical Trial Summary

This observational study will assess the effect of long-term treatment with Mircera (methoxy polyethylene glycol-epoetin beta) in chronic kidney disease patients with renal anemia. Data will be collected from each patient for at least 24 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1083
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients, >/= 18 years of age

• Patients with chronic kidney disease (CKD), stages IV and V

• Treatment with Mircera according to label

Exclusion Criteria:

• Pregnant or breastfeeding women

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anemia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin Levels at Monthly Intervals	Hemoglobin levels were measured as grams/deciliter (g/dL).	Prior to Day 1, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24	No
Primary	Percentage of Participants Within Pre-defined Range of Hemoglobin Values	Percentage of participants with hemoglobin values within the following pre-defined ranges is presented: 11-12 gram/deciliter (g/dL), 10-12 g/dL, 11-13 g/dL, and 10-13 g/dL.	Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24	No
Primary	Average Methoxy Polyethylene Glycol-epoetin Beta Dose	Average methoxy polyethylene glycol-epoetin beta dose per application by study month. Mean values were taken when more than 1 application was documented for a participant during the time period considered.	Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24	No