An Observational Study to Evaluate the Effectiveness of Mircera Treatment for Renal Anemia in Pre-dialysis Participants With Chronic Kideny Disease (CKD)

Kidney Disease, Chronic Clinical Trial

Official title:

Investigating the Effectiveness of Renal Anaemia Treatment in Pre-Dialysis Patients With Mircera in Daily Clinical Practice - MIRVITA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02547454
• Other study ID #: ML22069
• Status: Completed
• Phase: N/A
• First received: September 9, 2015
• Last updated: October 21, 2015
• Start date: December 2008
• Est. completion date: November 2014

Study information

• Verified date: October 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: The Republic of Slovenia: Public Agency of the Republic of Slovenia for Medicinal Products and Medical Devices
• Study type: Observational

Clinical Trial Summary

This observational trial will examine the efficacy and safety of Mircera for renal anemia in participants with stage III-IV CKD in daily clinical practice. Mircera will be prescribed by treating physician and followed for approximately 36 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 393
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Participants aged > 18 years with CKD

• Participants who are eligible for Mircera treatment according to current guidelines and summary of product characteristics (SmPC)

Exclusion Criteria:

• Non-renal anemia

• Pregnancy and breast-feeding

• Uncontrolled hypertension

• Known hypersensitivity to methoxy polyethylene glycol-epoetin beta

• Administration of any other study drug within 30 days prior to study enrollment

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Disease
• Kidney Disease, Chronic
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Methoxy polyethylene glycol-epoetin beta

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Hemoglobin (Hb) Value Within the Target Range (110 to 120 Grams Per Liter [g/L]) at Baseline	If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.	Baseline	No
Primary	Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 1-3	If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.	At Months 1-3	No
Primary	Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 4-6	If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.	At Months 4-6	No
Primary	Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 7-9	If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.	At Months 7-9	No
Primary	Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 10-12	If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.	At Months 10-12	No
Primary	Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 13-15	If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.	At Months 13-15	No
Primary	Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 16-18	If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.	At Months 16-18	No
Primary	Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 19-21	If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.	At Months 19-21	No
Primary	Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) After 21 Months up to 36 Months	If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.	After 21 Months up to 36 Months	No
Primary	Percentage of Participants With Hemoglobin (Hb) Value Within the Target Range (100 to 130 g/L) at Baseline	If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.	At Baseline	No
Primary	Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 1-3	If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.	At Months 1-3	No
Primary	Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 4-6	If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.	At Months 4-6	No
Primary	Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 7-9	If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.	At Months 7-9	No
Primary	Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 10-12	If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.	At Months 10-12	No
Primary	Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 13-15	If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.	At Months 13-15	No
Primary	Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 16-18	If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.	At Months 16-18	No
Primary	Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 19-21	If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.	At Months 19-21	No
Primary	Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) After 21 Months up to 36 Months	If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.	After 21 Months up to 36 Months	No
Secondary	Median Time in Which Hb Value Was Maintained Within Target Range of 110-120 g/L		Up to 36 Months	No
Secondary	Median Time in Which Hb Value Was Maintained Within Target Range of 100-130 g/L		Up to 36 Months	No
Secondary	Average Dose of Methoxy Polyethylene Glycol-Epoetin Beta	Average dose of methoxy polyethylene glycol-epoetin beta administered at Baseline	Baseline	No
Secondary	Median Dose of Methoxy Polyethylene Glycol-Epoetin Beta	Median monthly dose of methoxy polyethylene glycol-epoetin beta administered in the study up to 36 months.	Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21 and After 21 Months up to 36 Months	No
Secondary	Number of Dose Adaptations	Total number of changes (increase or decrease) in daily methoxy polyethylene glycol-epoetin beta doses. The reasons for dose-adaptations included: inflammation or infection; kidney function decline; over-response; iron deficiency; insufficient response; adverse effect; start of maintenance dose; kidney function improvement; re-introduction of treatment; and others (other reasons than specified).	Up to 36 Months	No
Secondary	Percentage of Participants With Dose 0	Percentage of participants who did not use methoxy polyethylene glycol-epoetin beta (Dose 0) at atleast one visit during study period.	Up to 36 Months	No
Secondary	Percentage of Participants With Iron Replacement	Iron replacement was given to the participants either in oral iron replacement or intravenous replacement or both.	Up to 36 Months	No