Trial Outcomes & Findings for An Observational Study of Mircera (Methoxy Polyethylene Glycol-epoetin Beta) in Patients With Chronic Kidney Disease Not On Dialysis (NCT NCT01318512)

NCT ID: NCT01318512

Last Updated: 2017-07-05

Results Overview

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

• Recruitment status: COMPLETED
• Target enrollment: 340 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2017-07-05

Participant Flow

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

Participant milestones

Measure	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.
Titration Period (4 Months) STARTED	340
Titration Period (4 Months) COMPLETED	340
Titration Period (4 Months) NOT COMPLETED	0
Maintenance Period (6 Months) STARTED	340
Maintenance Period (6 Months) COMPLETED	329
Maintenance Period (6 Months) NOT COMPLETED	11

Reasons for withdrawal

Measure	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.
Maintenance Period (6 Months) Death	2
Maintenance Period (6 Months) Protocol Violation	9

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Chronic Kidney Disease (CKD) n=340 Participants 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.
Age, Continuous	62.4 years STANDARD_DEVIATION 14.6 • n=5 Participants
Sex: Female, Male Female	172 Participants n=5 Participants
Sex: Female, Male Male	168 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

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

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

Outcome measures

Measure	Chronic Kidney Disease (CKD) n=340 Participants Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of hemoglobin.
Average Dose of MIRCERA at Entry Level	94 microgram (µg) Standard Deviation 49

PRIMARY outcome

Timeframe: Month 1

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

The average dose of MIRCERA, measured in microgram (µg) at each month interval during the titration period was reported.

Outcome measures

Measure	Chronic Kidney Disease (CKD) n=340 Participants Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of hemoglobin.
Average Dose of MIRCERA During Titration Period Month 1	101.3 microgram (µg) Standard Deviation 54

PRIMARY outcome

Timeframe: Month 2

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

The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the titration period was reported.

Outcome measures

Measure	Chronic Kidney Disease (CKD) n=340 Participants Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of hemoglobin.
Average Dose of MIRCERA During Titration Period Month 2	102.4 microgram (µg) Standard Deviation 54.3

PRIMARY outcome

Timeframe: Month 3

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

The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the titration period was reported.

Outcome measures

Measure	Chronic Kidney Disease (CKD) n=340 Participants Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of hemoglobin.
Average Dose of MIRCERA During Titration Period Month 3	106.1 microgram (µg) Standard Deviation 56.2

PRIMARY outcome

Timeframe: Month 4

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

The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the titration period was reported.

Outcome measures

Measure	Chronic Kidney Disease (CKD) n=340 Participants Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of hemoglobin.
Average Dose of MIRCERA During Titration Period Month 4	107.5 microgram (µg) Standard Deviation 59.8

PRIMARY outcome

Timeframe: Month 5 (Maintenance Period Month 1)

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

The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.

Outcome measures

Measure	Chronic Kidney Disease (CKD) n=340 Participants Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of hemoglobin.
Average Dose of MIRCERA During Maintenance Period Month 1	105 microgram (µg) Standard Deviation 61

PRIMARY outcome

Timeframe: Month 6 (Maintenance Period Month 2)

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

The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.

Outcome measures

Measure	Chronic Kidney Disease (CKD) n=340 Participants Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of hemoglobin.
Average Dose of MIRCERA During Maintenance Period Month 2	106 microgram (µg) Standard Deviation 61.7

PRIMARY outcome

Timeframe: Month 7 (Maintenance Period Month 3)

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

The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.

Outcome measures

Measure	Chronic Kidney Disease (CKD) n=340 Participants Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of hemoglobin.
Average Dose of MIRCERA During Maintenance Period Month 3	107 microgram (µg) Standard Deviation 63.6

PRIMARY outcome

Timeframe: Month 8 (Maintenance Period Month 4)

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

The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.

Outcome measures

Measure	Chronic Kidney Disease (CKD) n=340 Participants Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of hemoglobin.
Average Dose of MIRCERA During Maintenance Period Month 4	109 microgram (µg) Standard Deviation 66.5

PRIMARY outcome

Timeframe: Month 9 (Maintenance Period Month 5)

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

The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.

Outcome measures

Measure	Chronic Kidney Disease (CKD) n=340 Participants Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of hemoglobin.
Average Dose of MIRCERA During Maintenance Period Month 5	112 microgram (µg) Standard Deviation 66.2

PRIMARY outcome

Timeframe: Month 10 (Maintenance Period Month 6)

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

The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.

Outcome measures

Measure	Chronic Kidney Disease (CKD) n=340 Participants Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of hemoglobin.
Average Dose of MIRCERA During Maintenance Period Month 6	114 microgram (µg) Standard Deviation 65.9

SECONDARY outcome

Timeframe: Baseline, Month 1, 2, 3, 4

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

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.

Outcome measures

Measure	Chronic Kidney Disease (CKD) n=340 Participants Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of hemoglobin.
The Mean Hemoglobin (Hb) Level During Titration Period Baseline	93.9 g/L Standard Deviation 11.7
The Mean Hemoglobin (Hb) Level During Titration Period Month 1	98.4 g/L Standard Deviation 12.4
The Mean Hemoglobin (Hb) Level During Titration Period Month 2	103.4 g/L Standard Deviation 12.7
The Mean Hemoglobin (Hb) Level During Titration Period Month 3	106.3 g/L Standard Deviation 12.0
The Mean Hemoglobin (Hb) Level During Titration Period Month 4	108.4 g/L Standard Deviation 12.4

SECONDARY outcome

Timeframe: Month 5, 6, 7, 8, 9, 10

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

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

Outcome measures

Measure	Chronic Kidney Disease (CKD) n=340 Participants Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of hemoglobin.
The Mean Hemoglobin (Hb) Level During Maintenance Period Month 5	109.3 g/L Standard Deviation 11.6
The Mean Hemoglobin (Hb) Level During Maintenance Period Month 6	110.3 g/L Standard Deviation 10.3
The Mean Hemoglobin (Hb) Level During Maintenance Period Month 7	111.2 g/L Standard Deviation 9.8
The Mean Hemoglobin (Hb) Level During Maintenance Period Month 8	112.1 g/L Standard Deviation 10.3
The Mean Hemoglobin (Hb) Level During Maintenance Period Month 9	112.5 g/L Standard Deviation 10.9
The Mean Hemoglobin (Hb) Level During Maintenance Period Month 10	113.8 g/L Standard Deviation 10.9

Adverse Events

Chronic Kidney Disease (CKD)

Serious events: 5 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Chronic Kidney Disease (CKD) n=340 participants at risk Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of hemoglobin.
Cardiac disorders Cardiac failure left	0.29% 1/340 • 3.5 years
Infections and infestations Sepsis	0.29% 1/340 • 3.5 years
Infections and infestations Endocarditis infective	0.29% 1/340 • 3.5 years
Vascular disorders Peripheral arterial disease	0.29% 1/340 • 3.5 years
Injury, poisoning and procedural complications Post surgical haemorrhage	0.29% 1/340 • 3.5 years
Surgical and medical procedures Surgery	0.29% 1/340 • 3.5 years

Other adverse events

Measure	Chronic Kidney Disease (CKD) n=340 participants at risk Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of hemoglobin.
Nervous system disorders Headache	0.59% 2/340 • 3.5 years

Additional Information

Medical Communications

Hoffmann-LaRoche

Phone: 800-821-8590

Email: genentech@druginfo.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
• Publication restrictions are in place

Restriction type: OTHER