A Study of MIRCERA for the Intrapetient Variability of Hemoglobin Levels in Patients With Chronic Renal Anemia (RIVAL)

Anemia Clinical Trial

Official title:

Retrospective Study on Intrapatient VAriabiLity of the Hemoglobin Levels in Anemic CKD Patients in Predialysis (Stage 3-4) and Dialysis (Stage 5) Treated With MIRCERA® (RIVAL Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01356589
• Other study ID #: ML25289
• Status: Completed
• Phase: N/A
• First received: May 18, 2011
• Last updated: November 23, 2015
• Start date: September 2010
• Est. completion date: July 2012

Study information

• Verified date: November 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Observational

Clinical Trial Summary

This retrospective observational study will assess the incidence of hemoglobin cycling in chronic kidney disease (stage 3, 4, and 5) patients with renal anemia treated with Mircera (methoxy polyethylene glycol-epoetin beta). Data will be collected from each patient from a 9-month treatment period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1288
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients, >/= 18 years of age

• Chronic kidney disease in predialysis (stage 3 and 4) and dialysis

• Renal anemia treated with Mircera according to label for at least 9 months before date of signed informed consent

Exclusion Criteria:

• Participation in an interventional clinical trial within the retrospective observation period

• Contraindications to Mircera administration as per label or judged by the investigator

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

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

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With at Least One Hemoglobin Cycling	Hemoglobin cycling was defined as 1 or more cycles of oscillation in hemoglobin with an amplitude of greater than or equal to (>=) 1.5 gram per deciliter (g/dL) and a duration >=8 weeks.	9 months	No
Secondary	Number of Full Hemoglobin Cycles Per Participant	Hemoglobin cycling was defined as 1 or more cycles of oscillation in hemoglobin with an amplitude of >=1.5 g/dL and a duration >=8 weeks.	9 months	No
Secondary	Percentage of Participants With Type 2 Diabetes Who Experienced at Least 1 Hemoglobin Cycling	Hemoglobin cycling was defined as 1 or more cycles of oscillation in hemoglobin with an amplitude of >=1.5 g/dL and a duration >=8 weeks.	9 months	No