An Observational Study of Mircera (Methoxy Polyethylene Glycol-epoetin Beta) in Patients With Chronic Kidney Disease Not On Dialysis

The Dosage of MIRCERA in the Treatment of Renal Anaemia in Patients With Chronic Renal Disease Who do Not Undergo Haemodialysis in Clinical Practice

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01318512

Enrollment

340

Registered

2011-03-18

Start date

2010-07-31

Completion date

2013-12-31

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

Kidney Disease, Chronic

Brief summary

This observational, prospective, multicenter study will describe the mean dose of Mircera (methoxy polyethylene glycol-epoetin beta) and the hemoglobin levels in patients with chronic kidney disease. Patients are not on dialysis and are naive to, or have received erythropoiesis stimulating agent treatment. Data will be collected for 10 months.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Adults patients, \>/=18 years of age * Presence of chronic kidney disease (Stage 3-4)

Exclusion criteria

* Participation in another clinical study

Design outcomes

Primary

Measure	Time frame	Description
Average Dose of MIRCERA at Entry Level	Baseline	The average dose of MIRCERA, measured in micrograms (µg) at entry level was reported.
Average Dose of MIRCERA During Titration Period Month 1	Month 1	The average dose of MIRCERA, measured in microgram (µg) at each month interval during the titration period was reported.
Average Dose of MIRCERA During Titration Period Month 2	Month 2	The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the titration period was reported.
Average Dose of MIRCERA During Titration Period Month 3	Month 3	The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the titration period was reported.
Average Dose of MIRCERA During Titration Period Month 4	Month 4	The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the titration period was reported.
Average Dose of MIRCERA During Maintenance Period Month 1	Month 5 (Maintenance Period Month 1)	The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.
Average Dose of MIRCERA During Maintenance Period Month 2	Month 6 (Maintenance Period Month 2)	The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.
Average Dose of MIRCERA During Maintenance Period Month 3	Month 7 (Maintenance Period Month 3)	The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.
Average Dose of MIRCERA During Maintenance Period Month 4	Month 8 (Maintenance Period Month 4)	The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.
Average Dose of MIRCERA During Maintenance Period Month 5	Month 9 (Maintenance Period Month 5)	The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.
Average Dose of MIRCERA During Maintenance Period Month 6	Month 10 (Maintenance Period Month 6)	The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.

Secondary

Measure	Time frame	Description
The Mean Hemoglobin (Hb) Level During Titration Period	Baseline, Month 1, 2, 3, 4	The hemoglobin level was measured in grams per liter (g/L) at entry level and after each month of treatment with MIRCERA. The study did not distinguish between erythropoiesis stimulating agent naive and erythropoiesis stimulating agent treated participants, and collected the overall data (Hb level) before/after administration of MIRCERA.
The Mean Hemoglobin (Hb) Level During Maintenance Period	Month 5, 6, 7, 8, 9, 10	The hemoglobin level was measured in grams per liter (g/L) after each month of treatment with MIRCERA. The study did not distinguish between erythropoiesis stimulating agent naive and erythropoiesis stimulating agent treated participants, and collected the overall data (Hb level) before/after administration of MIRCERA

Countries

Czechia

Participant flow

Pre-assignment details

Study included Titration Period (4 months) and Maintenance Period (6 Months).

Participants by arm

Arm	Count
Chronic Kidney Disease (CKD) Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with methoxy polyethylene glycol-epoetin beta (MIRCERA) subcutaneously (SC) as per summary of product characteristics (SPC) due to decreased levels of hemoglobin.	340
Total	340

Withdrawals & dropouts

Period	Reason	FG000
Maintenance Period (6 Months)	Death	2
Maintenance Period (6 Months)	Protocol Violation	9

Baseline characteristics

Characteristic	Chronic Kidney Disease (CKD)
Age, Continuous	62.4 years STANDARD_DEVIATION 14.6
Sex: Female, Male Female	172 Participants
Sex: Female, Male Male	168 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	2 / 340
serious Total, serious adverse events	5 / 340

Outcome results

Primary

Average Dose of MIRCERA at Entry Level

The average dose of MIRCERA, measured in micrograms (µg) at entry level was reported.

Time frame: Baseline

Population: All participants who received at least one dose of MIRCERA during the titration period.

Arm	Measure	Value (MEAN)	Dispersion
Chronic Kidney Disease (CKD)	Average Dose of MIRCERA at Entry Level	94 microgram (µg)	Standard Deviation 49

Primary