Trial Outcomes & Findings for A Study of Subcutaneous Mircera for the Treatment of Anemia in Dialysis Patients. (NCT NCT00077623)

Last Updated: 2016-05-25

Results Overview

A time adjusted mean change in hemoglobin (Hb) concentration was calculated using an area under the curve (AUC) approach, for both periods separately. Change in Hb concentration between the baseline and evaluation periods was calculated by subtracting the calculated average baseline Hb value from the average evaluation period Hb value. All blood samples for Hb measurements were taken prior to study drug administration. Analysis used last observation carried forward (LOCF) for missing Hb values to correct for the impact of early dropouts. The baseline period is defined as Week -4 to Week -1. The evaluation period is defined as Week 29 to Week 36.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

572 participants

Primary outcome timeframe

Baseline (Week -4 to Week -1) and Evaluation period (Week 29 to Week 36)

Results posted on

2016-05-25

Participant Flow

A total of 817 participants were enrolled in this study conducted from 03 March 2004 to 23 September 2005 at 92 centers worldwide.

A total of 572 participants were randomized, of which 1 participant did not received the study drug.

Participant milestones

Participant milestones
Measure	RO0503821 (1x/2 Weeks) Eligible participants received RO0503821 (Mircera \[methoxy polyethylene glycol-epoetin beta\]) subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 microgram (mcg) which was based on the epoetin dose of\<8000, 8000-16000, or \>16000 international units per week (IU/week), administered during the week preceding the switch to the study drug.	RO0503821 (1x/4 Weeks) Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of\<8000, 8000-16000, or \>16000 IU/week administered during the week preceding the switch to the study drug.	Epoetin Reference Eligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks.
Overall Study STARTED	190	191	191
Overall Study COMPLETED	154	148	159
Overall Study NOT COMPLETED	36	43	32

Reasons for withdrawal

Reasons for withdrawal
Measure	RO0503821 (1x/2 Weeks) Eligible participants received RO0503821 (Mircera \[methoxy polyethylene glycol-epoetin beta\]) subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 microgram (mcg) which was based on the epoetin dose of\<8000, 8000-16000, or \>16000 international units per week (IU/week), administered during the week preceding the switch to the study drug.	RO0503821 (1x/4 Weeks) Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of\<8000, 8000-16000, or \>16000 IU/week administered during the week preceding the switch to the study drug.	Epoetin Reference Eligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks.
Overall Study Adverse Event	1	0	1
Overall Study Withdrawal by Subject	2	10	1
Overall Study Other-Non safety reason	18	15	19
Overall Study Insufficient therapeutic response	2	0	0
Overall Study Death	12	18	11
Overall Study Failure to return	1	0	0

Baseline Characteristics

A Study of Subcutaneous Mircera for the Treatment of Anemia in Dialysis Patients.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RO0503821 (1x/2 Weeks) n=190 Participants Eligible participants received RO0503821 subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 mcg which was based on the Epoetin dose of\<8000, 8000-16000,or \>16000 International units \[IU\]/Week, administered during the week preceding the switch to the study drug.	RO0503821 (1x/4 Weeks) n=190 Participants Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the Epoetin dose of\<8000, 8000-16000, or \>16000 IU/Week administered during the week preceding the switch to the study drug.	Epoetin Reference n=191 Participants Eligible participants received their ongoing weekly subcutaneous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.	Total n=571 Participants Total of all reporting groups
Age, Continuous	60.5 years STANDARD_DEVIATION 15.40 • n=93 Participants	62.5 years STANDARD_DEVIATION 15.16 • n=4 Participants	60.4 years STANDARD_DEVIATION 14.70 • n=27 Participants	61.1 years STANDARD_DEVIATION 15.10 • n=483 Participants
Sex: Female, Male Female	82 Participants n=93 Participants	73 Participants n=4 Participants	81 Participants n=27 Participants	236 Participants n=483 Participants
Sex: Female, Male Male	108 Participants n=93 Participants	117 Participants n=4 Participants	110 Participants n=27 Participants	335 Participants n=483 Participants

PRIMARY outcome

Timeframe: Baseline (Week -4 to Week -1) and Evaluation period (Week 29 to Week 36)

Population: The Per Protocol population included all randomized participants except those not meeting inclusion criterion related to stable baseline Hb values, inadequate iron status, hemoglobinopathies/hemolysis, RBC transfusion/blood loss, with \<5 recorded Hb values during the evaluation period, with missing administrations of the study drug/ reference drug

Outcome measures

Outcome measures
Measure	RO0503821 (1x/2 Weeks) n=154 Participants Eligible participants received RO0503821 subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 mcg which was based on the epoetin dose of\<8000, 8000-16000, or \>16000 IU/week, administered during the week preceding the switch to the study drug.	RO0503821 (1x/4 Weeks) n=153 Participants Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of\<8000, 8000-16000, or \>16000 IU/week administered during the week preceding the switch to the study drug.	Epoetin Reference n=167 Participants Eligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks.
Mean Change in Hemoglobin Concentration From Baseline to Evaluation Periods	-0.00 g/dL Standard Deviation 0.96	-0.11 g/dL Standard Deviation 0.97	-0.12 g/dL Standard Deviation 1.04

SECONDARY outcome

Timeframe: Evaluation period (Week 29 to Week 36)

Population: The Intent-to-Treat (ITT) population included all randomized participants.

All mean Hb values recorded during the evaluation period were calculated and subtracted from the mean baseline Hb value for each participant. The number of participants maintaining their average Hb within +/- 1 g/dL of their average baseline hemoglobin concentration is given. The evaluation period is defined as Week 29 to Week 36.

Outcome measures

Outcome measures
Measure	RO0503821 (1x/2 Weeks) n=164 Participants Eligible participants received RO0503821 subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 mcg which was based on the epoetin dose of\<8000, 8000-16000, or \>16000 IU/week, administered during the week preceding the switch to the study drug.	RO0503821 (1x/4 Weeks) n=168 Participants Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of\<8000, 8000-16000, or \>16000 IU/week administered during the week preceding the switch to the study drug.	Epoetin Reference n=176 Participants Eligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks.
Number of Participants Maintaining Average Hb Concentration During the Evaluation Period Within +-1 g/dL of Their Average Baseline Hb Concentration	124 participants	111 participants	127 participants

SECONDARY outcome

Timeframe: Up to Week 36

Population: Safety population included all participants who received at least one dose of study drug.

The number of participants who received RBC transfusions were reported.

Outcome measures

Outcome measures
Measure	RO0503821 (1x/2 Weeks) n=190 Participants Eligible participants received RO0503821 subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 mcg which was based on the epoetin dose of\<8000, 8000-16000, or \>16000 IU/week, administered during the week preceding the switch to the study drug.	RO0503821 (1x/4 Weeks) n=190 Participants Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of\<8000, 8000-16000, or \>16000 IU/week administered during the week preceding the switch to the study drug.	Epoetin Reference n=191 Participants Eligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks.
Number of Participants With Red Blood Cell Transfusions	12 participants	20 participants	19 participants

SECONDARY outcome

Timeframe: Up to week 52

Population: Safety population included all participants who received at least one dose of study drug.

An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Outcome measures

Outcome measures
Measure	RO0503821 (1x/2 Weeks) n=190 Participants Eligible participants received RO0503821 subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 mcg which was based on the epoetin dose of\<8000, 8000-16000, or \>16000 IU/week, administered during the week preceding the switch to the study drug.	RO0503821 (1x/4 Weeks) n=190 Participants Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of\<8000, 8000-16000, or \>16000 IU/week administered during the week preceding the switch to the study drug.	Epoetin Reference n=191 Participants Eligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks.
Number of Participants With Any Adverse Events, Any Serious Adverse Events, and Deaths Any AE's	171 participants	177 participants	167 participants
Number of Participants With Any Adverse Events, Any Serious Adverse Events, and Deaths Any SAE's	70 participants	73 participants	85 participants
Number of Participants With Any Adverse Events, Any Serious Adverse Events, and Deaths Deaths	13 participants	18 participants	12 participants

SECONDARY outcome

Timeframe: Up to week 52

Population: Safety population included all participants who received at least one dose of study drug. Maximum number of participants available at the time of assessment were denoted as 'n'.

A marked abnormality range was defined as above and/or below a value which was considered to be potentially clinically relevant. Marked laboratory abnormalities were analyzed according to the Roche specified limits for the reference range of the following laboratory parameters: White blood cells (WBC) (3.0- 18.0 10\^9/L), platelets (100 - 550 10\^9/L), alanine aminotransferase (ALAT) (0 - 110 units per liter \[U/L\]), alkaline phosphatase (ALP \[0 - 220 U/L\]), aspartate aminotransferase (ASAT) (0 - 80 U/L), albumin \>= 30 g/L, phosphate (0.75 - 1.60 millimoles per liter \[mmol/L\]), potassium (2.9 - 5.8 mmol/L), glucose (2.80 - 11.10 mmol/L).

Outcome measures

Outcome measures
Measure	RO0503821 (1x/2 Weeks) n=189 Participants Eligible participants received RO0503821 subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 mcg which was based on the epoetin dose of\<8000, 8000-16000, or \>16000 IU/week, administered during the week preceding the switch to the study drug.	RO0503821 (1x/4 Weeks) n=189 Participants Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of\<8000, 8000-16000, or \>16000 IU/week administered during the week preceding the switch to the study drug.	Epoetin Reference n=188 Participants Eligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks.
Number of Participants With Marked Laboratory Abnormalities Phosphate, low; n=189,189, 188	14 participants	17 participants	18 participants
Number of Participants With Marked Laboratory Abnormalities Glucose fasting, high; n=126,137, 124	1 participants	2 participants	2 participants
Number of Participants With Marked Laboratory Abnormalities Platelets, high; n=189,189, 188	0 participants	1 participants	1 participants
Number of Participants With Marked Laboratory Abnormalities Platelets, low; n=189,189, 188	8 participants	11 participants	1 participants
Number of Participants With Marked Laboratory Abnormalities RBC, high; n = 118, 112, 115	0 participants	2 participants	1 participants
Number of Participants With Marked Laboratory Abnormalities RBC, low; n = 118, 112, 115	48 participants	48 participants	73 participants
Number of Participants With Marked Laboratory Abnormalities WBC, high; n=189,189, 188	1 participants	2 participants	5 participants
Number of Participants With Marked Laboratory Abnormalities WBC, low; n=189,189, 188	3 participants	4 participants	4 participants
Number of Participants With Marked Laboratory Abnormalities ALAT, high; n=189,189, 188	6 participants	11 participants	6 participants
Number of Participants With Marked Laboratory Abnormalities ALP, high; n=189,189, 188	5 participants	8 participants	11 participants
Number of Participants With Marked Laboratory Abnormalities ASAT, high; n=185,189, 186	4 participants	5 participants	2 participants
Number of Participants With Marked Laboratory Abnormalities Albumin, low; n=182,186, 185	16 participants	20 participants	17 participants
Number of Participants With Marked Laboratory Abnormalities Phosphate, high; n=189,189, 188	84 participants	78 participants	82 participants
Number of Participants With Marked Laboratory Abnormalities Potassium, high; n=189,189, 188	32 participants	38 participants	38 participants
Number of Participants With Marked Laboratory Abnormalities Potassium, low; n=189,189, 188	1 participants	4 participants	1 participants
Number of Participants With Marked Laboratory Abnormalities Glucose fasting, low; n=126,137, 124	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: From Baseline (Week -4 to Week -1) to Week 36 and Week 52

Population: Safety population included all participants who received at least one dose of study drug. Maximum number of participants available at the time of assessment was denoted as 'n'.

Systolic blood pressure (SBP) and diastolic blood pressure (DBP) was measured in sitting position before and after dialysis session in haemodialysis participants.

Outcome measures

Outcome measures
Measure	RO0503821 (1x/2 Weeks) n=150 Participants Eligible participants received RO0503821 subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 mcg which was based on the epoetin dose of\<8000, 8000-16000, or \>16000 IU/week, administered during the week preceding the switch to the study drug.	RO0503821 (1x/4 Weeks) n=153 Participants Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of\<8000, 8000-16000, or \>16000 IU/week administered during the week preceding the switch to the study drug.	Epoetin Reference n=158 Participants Eligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks.
Change From Baseline in Systolic and Diastolic Blood Pressure - at Weeks 36 and 52 in Hemodialysis Participants DBP- before dialysis (Week 36, n=150,153, 157)	0 mmHG Standard Deviation 12.2	0 mmHG Standard Deviation 15.5	1 mmHG Standard Deviation 14.6
Change From Baseline in Systolic and Diastolic Blood Pressure - at Weeks 36 and 52 in Hemodialysis Participants DBP- before dialysis (Week 52, n= 143, 136, 144)	-1 mmHG Standard Deviation 13.8	-1 mmHG Standard Deviation 11.1	2 mmHG Standard Deviation 14.3
Change From Baseline in Systolic and Diastolic Blood Pressure - at Weeks 36 and 52 in Hemodialysis Participants DBP - After dialysis (Week 36, n=150, 150, 157)	1 mmHG Standard Deviation 13.2	-0 mmHG Standard Deviation 17.3	-1 mmHG Standard Deviation 15.7
Change From Baseline in Systolic and Diastolic Blood Pressure - at Weeks 36 and 52 in Hemodialysis Participants DBP - After dialysis (Week 52, n= 141, 136, 142)	0 mmHG Standard Deviation 15	0 mmHG Standard Deviation 14.9	2 mmHG Standard Deviation 15.6
Change From Baseline in Systolic and Diastolic Blood Pressure - at Weeks 36 and 52 in Hemodialysis Participants SBP - before dialysis(Week 36, n=150, 153, 158)	1 mmHG Standard Deviation 22.1	4 mmHG Standard Deviation 26.1	-1 mmHG Standard Deviation 22.7
Change From Baseline in Systolic and Diastolic Blood Pressure - at Weeks 36 and 52 in Hemodialysis Participants SBP - before dialysis(Week 52, n=143, 136,144)	-1 mmHG Standard Deviation 25.2	3 mmHG Standard Deviation 23.1	1 mmHG Standard Deviation 23.4
Change From Baseline in Systolic and Diastolic Blood Pressure - at Weeks 36 and 52 in Hemodialysis Participants SBP - After dialysis (Week 36, n=150, 152, 158)	-1 mmHG Standard Deviation 24.4	-0 mmHG Standard Deviation 27.1	-2 mmHG Standard Deviation 26.8
Change From Baseline in Systolic and Diastolic Blood Pressure - at Weeks 36 and 52 in Hemodialysis Participants SBP - After dialysis (Week 52, n=141, 136, 142)	1 mmHG Standard Deviation 24.1	-2 mmHG Standard Deviation 23.4	2 mmHG Standard Deviation 23.9

SECONDARY outcome

Timeframe: From Baseline (Week -4 to Week -1) to Week 36 and Week 52

Population: Safety population included all participants who received at least one dose of study drug. Maximum number of participants available at the time of assessment was denoted as 'n'.

Pulse rate in beats per minute (BpM) was measured at each study visit, i.e., once a week during the dose titration and evaluation periods, once every two weeks during the long-term safety observation period and at the final visit. It was measured before blood sampling and RO0503821/epoetin administration and before the dialysis session in haemodialysis participants.

Outcome measures

Outcome measures
Measure	RO0503821 (1x/2 Weeks) n=147 Participants Eligible participants received RO0503821 subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 mcg which was based on the epoetin dose of\<8000, 8000-16000, or \>16000 IU/week, administered during the week preceding the switch to the study drug.	RO0503821 (1x/4 Weeks) n=149 Participants Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of\<8000, 8000-16000, or \>16000 IU/week administered during the week preceding the switch to the study drug.	Epoetin Reference n=156 Participants Eligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks.
Change From Baseline in Pulse Rate at Weeks 36 and 52 in Hemodialysis Participants Pulse rate (Week 36, n=147,149, 156 )	-0 BpM Standard Deviation 11.8	1 BpM Standard Deviation 11.3	-0 BpM Standard Deviation 12.0
Change From Baseline in Pulse Rate at Weeks 36 and 52 in Hemodialysis Participants Pulse rate (Week 52, n= 140, 135, 142)	-0 BpM Standard Deviation 10.6	1 BpM Standard Deviation 12.5	-0 BpM Standard Deviation 12.3

SECONDARY outcome

Timeframe: From Baseline (Week -4 to Week -1) to Week 36 and Week 52

Population: Safety population included all participants who received at least one dose of study medication. Maximum number of participants available at the time of assessment were analysed and reported.

Systolic blood pressure (SBP) and diastolic blood pressure (DBP) was measured in sitting position before and after dialysis session in peritoneal dialysis participants.

Outcome measures

Outcome measures
Measure	RO0503821 (1x/2 Weeks) n=8 Participants Eligible participants received RO0503821 subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 mcg which was based on the epoetin dose of\<8000, 8000-16000, or \>16000 IU/week, administered during the week preceding the switch to the study drug.	RO0503821 (1x/4 Weeks) n=10 Participants Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of\<8000, 8000-16000, or \>16000 IU/week administered during the week preceding the switch to the study drug.	Epoetin Reference n=12 Participants Eligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks.
Change From Baseline in Systolic and Diastolic Blood Pressure at Weeks 36 and 52 in Peritoneal Dialysis Participants SBP - (Week 36, n=7, 10, 12)	3 mm HG Standard Deviation 26.7	-20 mm HG Standard Deviation 33.5	7 mm HG Standard Deviation 29
Change From Baseline in Systolic and Diastolic Blood Pressure at Weeks 36 and 52 in Peritoneal Dialysis Participants DBP (Week 36, n=7,10,12 )	2 mm HG Standard Deviation 12.8	-7 mm HG Standard Deviation 13.9	2 mm HG Standard Deviation 15.5
Change From Baseline in Systolic and Diastolic Blood Pressure at Weeks 36 and 52 in Peritoneal Dialysis Participants DBP (Week 52, n= 8, 9, 12)	1 mm HG Standard Deviation 10.3	-8 mm HG Standard Deviation 18.7	2 mm HG Standard Deviation 18.5
Change From Baseline in Systolic and Diastolic Blood Pressure at Weeks 36 and 52 in Peritoneal Dialysis Participants SBP - (Week 52, n=8, 9,12)	4 mm HG Standard Deviation 22.1	-20 mm HG Standard Deviation 36.9	12 mm HG Standard Deviation 19.6

SECONDARY outcome

Timeframe: From Baseline (Week -4 to Week -1) to Week 36 and Week 52

Population: Safety population included all participants who received at least one dose of study drug. Maximum number of participants available at the time of assessment was denoted as 'n'.

Pulse rate in BpM was measured at each study visit, i.e., once a week during the dose titration and evaluation periods, once every two weeks during the long-term safety observation period and at the final visit. It was measured before blood sampling and RO0503821/epoetin administration and before the dialysis session in peritoneal dialysis participants.

Outcome measures

Outcome measures
Measure	RO0503821 (1x/2 Weeks) n=147 Participants Eligible participants received RO0503821 subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 mcg which was based on the epoetin dose of\<8000, 8000-16000, or \>16000 IU/week, administered during the week preceding the switch to the study drug.	RO0503821 (1x/4 Weeks) n=149 Participants Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of\<8000, 8000-16000, or \>16000 IU/week administered during the week preceding the switch to the study drug.	Epoetin Reference n=156 Participants Eligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks.
Change From Baseline in Pulse Rate - Peritoneal Dialysis Participants Pulse rate (Week 36, n=147,149, 156)	1 BpM Standard Deviation 16.7	4 BpM Standard Deviation 12.2	6 BpM Standard Deviation 6.9
Change From Baseline in Pulse Rate - Peritoneal Dialysis Participants Pulse rate (Week 52, n= 140, 135, 142)	-3 BpM Standard Deviation 12.7	1 BpM Standard Deviation 7.8	2 BpM Standard Deviation 7.8

Adverse Events

RO0503821 (1x/2 Weeks)

Serious events: 70 serious events

Other events: 113 other events

Deaths: 0 deaths

RO0503821 (1x/4 Weeks)

Serious events: 73 serious events

Other events: 131 other events

Deaths: 0 deaths

Epoetin Reference

Serious events: 85 serious events

Other events: 111 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Roche Trial Information Hotline

F. Hoffmann-La Roche AG

Phone: +41 616878333

Email: [email protected]

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

Measure	RO0503821 (1x/2 Weeks) n=190 participants at risk Eligible participants received RO0503821 subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 mcg which was based on the epoetin dose of\<8000, 8000-16000, or \>16000 IU/week, administered during the week preceding the switch to the study drug.	RO0503821 (1x/4 Weeks) n=190 participants at risk Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of\<8000, 8000-16000, or \>16000 IU/week administered during the week preceding the switch to the study drug.	Epoetin Reference n=191 participants at risk Eligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks.
Injury, poisoning and procedural complications Procedural hypotension	8.4% 16/190 • Up to Week 52 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	14.7% 28/190 • Up to Week 52 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	9.9% 19/191 • Up to Week 52 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Injury, poisoning and procedural complications Arteriovenous fistula site haemorrhage	7.4% 14/190 • Up to Week 52 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	7.9% 15/190 • Up to Week 52 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	2.6% 5/191 • Up to Week 52 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Injury, poisoning and procedural complications Arteriovenous fistula thrombosis	5.8% 11/190 • Up to Week 52 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	6.8% 13/190 • Up to Week 52 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	3.1% 6/191 • Up to Week 52 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Injury, poisoning and procedural complications Arteriovenous fistula site complication	3.2% 6/190 • Up to Week 52 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	5.8% 11/190 • Up to Week 52 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	4.7% 9/191 • Up to Week 52 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Injury, poisoning and procedural complications Procedural hypertension	3.7% 7/190 • Up to Week 52 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	6.8% 13/190 • Up to Week 52 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	2.1% 4/191 • Up to Week 52 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Infections and infestations Nasopharyngitis	9.5% 18/190 • Up to Week 52 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	10.0% 19/190 • Up to Week 52 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	9.4% 18/191 • Up to Week 52 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Infections and infestations Upper respiratory tract infection	6.3% 12/190 • Up to Week 52 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	6.3% 12/190 • Up to Week 52 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	5.8% 11/191 • Up to Week 52 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Infections and infestations Bronchitis	3.2% 6/190 • Up to Week 52 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	6.8% 13/190 • Up to Week 52 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	5.8% 11/191 • Up to Week 52 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Musculoskeletal and connective tissue disorders Muscle spasms	8.4% 16/190 • Up to Week 52 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	7.4% 14/190 • Up to Week 52 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	8.9% 17/191 • Up to Week 52 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Musculoskeletal and connective tissue disorders Pain in extremity	5.8% 11/190 • Up to Week 52 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	4.2% 8/190 • Up to Week 52 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	5.2% 10/191 • Up to Week 52 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Musculoskeletal and connective tissue disorders Arthralgia	2.6% 5/190 • Up to Week 52 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	6.8% 13/190 • Up to Week 52 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	5.2% 10/191 • Up to Week 52 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Musculoskeletal and connective tissue disorders Osteoarthritis	1.1% 2/190 • Up to Week 52 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	5.8% 11/190 • Up to Week 52 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	2.6% 5/191 • Up to Week 52 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Gastrointestinal disorders Diarrhoea	9.5% 18/190 • Up to Week 52 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	7.9% 15/190 • Up to Week 52 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	7.3% 14/191 • Up to Week 52 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Gastrointestinal disorders Abdominal pain upper	2.1% 4/190 • Up to Week 52 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	5.8% 11/190 • Up to Week 52 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	2.6% 5/191 • Up to Week 52 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Nervous system disorders Headache	7.9% 15/190 • Up to Week 52 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	10.0% 19/190 • Up to Week 52 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	9.9% 19/191 • Up to Week 52 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Metabolism and nutrition disorders Fluid overload	4.7% 9/190 • Up to Week 52 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	6.8% 13/190 • Up to Week 52 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	8.4% 16/191 • Up to Week 52 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Cardiac disorders Angina pectoris	0.00% 0/190 • Up to Week 52 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	6.8% 13/190 • Up to Week 52 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	1.0% 2/191 • Up to Week 52 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.
Vascular disorders Hypertension	14.2% 27/190 • Up to Week 52 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	15.8% 30/190 • Up to Week 52 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.	13.1% 25/191 • Up to Week 52 Serious adverse events and non-serious adverse events are reported in safety analysis set, which consists of all participants who received at least one dose of study drug and had a safety assessment performed post baseline.