An Observational Study of Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) in Stage V Chronic Kidney Disease Participants on Hemodialysis

An Observational, Non-Interventional Cohort Study to Observe the Efficacy and Use of MIRCERA in the Treatment of Chronic Renal Anaemia in Patients With Chronic Kidney Disease Stage V on Haemodialysis

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01940484

Enrollment

Registered

2013-09-12

Start date

2009-08-31

Completion date

2012-07-31

Last updated

2017-07-05

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

Conditions

Anemia

Brief summary

This observational study will evaluate the efficacy and use of Methoxy polyethylene glycol-epoetin beta (Mircera) in participants with Stage V chronic kidney disease on hemodialysis receiving an erythropoietin prior to study entry. Attending physicians should have made the decision of placing the participant on methoxy polyethylene glycol epoetin beta in advance and not related to the study. The therapy will be administered by the attendant treating physician according to specifications in the package insert guidelines and to the routine of the site.

Interventions

DRUGMethoxy polyethylene glycol epoetin beta

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Participants with chronic renal anemia with Stage V chronic kidney disease on hemodialysis and with a hemoglobin level of 10.0 - 13.0 grams per deciliter (g/dL) * Participants had to be receiving an ESA prior to entering the study * Female participants of childbearing age had to be using effective contraceptive methods

Exclusion criteria

* As per approved package insert * Any contraindication to ESA treatment

Design outcomes

Primary

Measure	Time frame
Mean Hemoglobin Value at Visit 7 (Month 6)	Visit 7 (Month 6)
Mean Hemoglobin Value at Visit 4 (Month 3)	Visit 4 (Month 3)
Mean Hemoglobin Value at Visit 5 (Month 4)	Visit 5 (Month 4)
Mean Hemoglobin Value at Visit 6 (Month 5)	Visit 6 (Month 5)
Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 6 (Month 5)	Visit 6 (Month 5)
Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 2 (Month 1)	Visit 2 (Month 1)
Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 3 (Month 2)	Visit 3 (Month 2)
Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 4 (Month 3)	Visit 4 (Month 3)
Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 5 (Month 4)	Visit 5 (Month 4)
Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 7 (Month 6)	Visit 7 (Month 6)
Mean Hemoglobin Value at Visit 2 (Month 1)	Visit 2 (Month 1)
Mean Hemoglobin Value at Visit 3 (Month 2)	Visit 3 (Month 2)

Secondary

Measure	Time frame	Description
Number of Participants With Dose Adjustments of Methoxy Polyethylene Glycol-Epoetin Beta	Visit 2 (Month 1), Visit 3 (Month 2), Visit 4 (Month 3), Visit 5 (Month 4), Visit 6 (Month 5), Visit 7 (Month 6), Visit 8 (Month 7)	Dose adjustment included dose increase or dose decrease with respect to previous visit's dose.
Number of Participants Treated According to European Renal Best Practice Guideline (ERBPG) and National Kidney Function (NKF) Kidney Disease Outcomes Quality Initiative (NKF KDOQI) and Mircera Package Insert	Up to 6 months	Number of participants who received treatment as per the guidelines specified by ERBPG, NKF KDOQI, and Mircera package insert were to be reported.
Mean Methoxy Polyethylene Glycol-Epoetin Beta Dose During the Study	Visit 2 (Month 1), Visit 3 (Month 2), Visit 4 (Month 3), Visit 5 (Month 4), Visit 6 (Month 5), Visit 7 (Month 6)	—

Countries

South Africa

Participant flow

Participants by arm

Arm	Count
Chronic Renal Anemia Participants Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.	98
Total	98

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event	1
Overall Study	Death	2
Overall Study	Underwent transplantation	4
Overall Study	Withdrawal by Subject	3

Baseline characteristics

Characteristic	Chronic Renal Anemia Participants
Age, Continuous	52.5 years STANDARD_DEVIATION 15.7
Body Weight	75.0 kilograms STANDARD_DEVIATION 18.5
Diastolic blood pressure (DBP) DBP post-dialysis (n=93)	78.8 millimeters of Mercury (mm Hg) STANDARD_DEVIATION 13.8
Diastolic blood pressure (DBP) DBP pre-dialysis (n=95)	82.5 millimeters of Mercury (mm Hg) STANDARD_DEVIATION 13.6
Height	167.5 centimeters (cm) STANDARD_DEVIATION 10.3
Mean Hemoglobin Value	11.57 g/dL STANDARD_DEVIATION 1.47
Methoxy Polyethylene Glycol-Epoetin Beta Dose	107.47 micrograms (mcg) STANDARD_DEVIATION 41.8
Number of Participants With Hemoglobin Level Within the Range of 11-12 Grams Per Deciliter (g/dL)	25 participants
Pulse rate	73.4 beats per minute STANDARD_DEVIATION 13.1
Sex: Female, Male Female	39 Participants
Sex: Female, Male Male	59 Participants
Systolic Blood Pressure (SBP) SBP post-dialysis (n=93)	136.7 mm Hg STANDARD_DEVIATION 19.6
Systolic Blood Pressure (SBP) SBP pre-dialysis (n=95)	145.7 mm Hg STANDARD_DEVIATION 18.8

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	0 / 0
serious Total, serious adverse events	79 / 98