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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02547454

Enrollment

393

Registered

2015-09-11

Start date

2008-12-31

Completion date

2014-11-30

Last updated

2017-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Disease, Chronic

Brief 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.

Interventions

DRUGMethoxy polyethylene glycol-epoetin beta

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) After 21 Months up to 36 Months	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.
Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 1-3	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.
Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 4-6	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.
Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 7-9	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.
Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 10-12	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.
Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 13-15	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.
Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 16-18	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.
Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 19-21	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.
Percentage of Participants With Hemoglobin (Hb) Value Within the Target Range (110 to 120 Grams Per Liter [g/L]) at Baseline	Baseline	If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 1-3	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.
Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 4-6	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.
Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 7-9	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.
Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 10-12	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.
Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 13-15	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.
Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 16-18	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.
Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 19-21	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.
Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) After 21 Months up to 36 Months	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.
Percentage of Participants With Hemoglobin (Hb) Value Within the Target Range (100 to 130 g/L) at Baseline	At Baseline	If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.

Secondary

Measure	Time frame	Description
Median Time in Which Hb Value Was Maintained Within Target Range of 100-130 g/L	Up to 36 Months	—
Average Dose of Methoxy Polyethylene Glycol-Epoetin Beta	Baseline	Average dose of methoxy polyethylene glycol-epoetin beta administered at Baseline
Median Dose of Methoxy Polyethylene Glycol-Epoetin Beta	Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21 and After 21 Months up to 36 Months	Median monthly dose of methoxy polyethylene glycol-epoetin beta administered in the study up to 36 months.
Number of Dose Adaptations	Up to 36 Months	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).
Percentage of Participants With Dose 0	Up to 36 Months	Percentage of participants who did not use methoxy polyethylene glycol-epoetin beta (Dose 0) at atleast one visit during study period.
Percentage of Participants With Iron Replacement	Up to 36 Months	Iron replacement was given to the participants either in oral iron replacement or intravenous replacement or both.
Median Time in Which Hb Value Was Maintained Within Target Range of 110-120 g/L	Up to 36 Months	—

Countries

Slovenia

Participant flow

Participants by arm

Arm	Count
Methoxy Polyethylene Glycol-Epoetin Beta Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.	393
Total	393

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Death	38
Overall Study	Due to hemodialysis	53
Overall Study	Due to no further need to treat	4
Overall Study	Due to transplantation	1
Overall Study	Lost to Follow-up	26
Overall Study	No data	11
Overall Study	Other	39

Baseline characteristics

Characteristic	Methoxy Polyethylene Glycol-Epoetin Beta
Age, Continuous	73 years STANDARD_DEVIATION 11.5
Sex: Female, Male Female	216 Participants
Sex: Female, Male Male	177 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	2 / 393
serious Total, serious adverse events	3 / 393