Trial Outcomes & Findings for A Study of Mircera for the Maintenance Treatment of Anemia in Dialysis Patients (NCT NCT00394953)

Last Updated: 2017-01-20

Results Overview

Randomized participants with an average hemoglobin (Hb) decrease from Baseline (Week -4 to Week -1) not exceeding 1.0 gram per deciliter (g/dL) and an absolute average Hb \>= 10.5 g/dL during the evaluation period (Weeks 50-53) were defined as responders. Non-responders included participants without any Hb data during the second treatment period and those who did not meet the response criteria and thus were not included in the analysis.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

490 participants

Primary outcome timeframe

Baseline (Week -4 to Week -1) and Evaluation period (Weeks 50 to 53)

Results posted on

2017-01-20

Participant Flow

The study was conducted from 20 December 2006 to 27 November 2008 in Europe along with Canada and Australia. A total of 490 eligible participants were enrolled.

Out of 490 participants, one did not receive the study drug and was excluded from the safety population.

Participant milestones

Participant milestones
Measure	MIRCERA Participants with anemia in chronic kidney disease (CKD) who were on hemodialysis received methoxy polyethylene glycol-epoetin beta (MIRCERA \[RO0503821\]) intravenously (IV) once every month up to 52 weeks. The starting dose of MIRCERA administered during the treatment period was dependent on the dose of darbepoetin alfa administered during screening period and was 120, 200 and 360 microgram per month (mcg/month) for weekly darbepoetin alfa doses of \<40, 40-80, and \>80 mcg, respectively.	Darbepoetin Alfa Participants with anemia in CKD who were on hemodialysis received darbepoetin alfa IV once every two weeks up to 26 weeks and received darbepoetin alfa IV twice the dose than earlier, once every month from Week 27 to Week 52.
First Treatment Period STARTED	245	244
First Treatment Period COMPLETED	216	222
First Treatment Period NOT COMPLETED	29	22
Second Treatment Period STARTED	216	222
Second Treatment Period COMPLETED	187	148
Second Treatment Period NOT COMPLETED	29	74

Reasons for withdrawal

Reasons for withdrawal
Measure	MIRCERA Participants with anemia in chronic kidney disease (CKD) who were on hemodialysis received methoxy polyethylene glycol-epoetin beta (MIRCERA \[RO0503821\]) intravenously (IV) once every month up to 52 weeks. The starting dose of MIRCERA administered during the treatment period was dependent on the dose of darbepoetin alfa administered during screening period and was 120, 200 and 360 microgram per month (mcg/month) for weekly darbepoetin alfa doses of \<40, 40-80, and \>80 mcg, respectively.	Darbepoetin Alfa Participants with anemia in CKD who were on hemodialysis received darbepoetin alfa IV once every two weeks up to 26 weeks and received darbepoetin alfa IV twice the dose than earlier, once every month from Week 27 to Week 52.
First Treatment Period Adverse Event	1	2
First Treatment Period Death	6	7
First Treatment Period Lack of Efficacy	1	1
First Treatment Period Withdrawal by Subject	6	3
First Treatment Period Lost to Follow-up	0	1
First Treatment Period Renal transplant	11	7
First Treatment Period Not defined	4	1
Second Treatment Period Adverse Event	2	5
Second Treatment Period Death	8	4
Second Treatment Period Lack of Efficacy	9	47
Second Treatment Period Withdrawal by Subject	3	3
Second Treatment Period Lost to Follow-up	0	1
Second Treatment Period Renal transplant	4	6
Second Treatment Period Not defined	3	8

Baseline Characteristics

A Study of Mircera for the Maintenance Treatment of Anemia in Dialysis Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MIRCERA n=245 Participants Participants with anemia in CKD who were on hemodialysis received MIRCERA IV once every month up to 52 weeks. The starting dose of MIRCERA administered during the treatment period was dependent on the dose of darbepoetin alfa administered during screening period and was 120, 200 and 360 mcg/month for weekly darbepoetin alfa doses of \<40, 40-80, and \>80 mcg, respectively.	Darbepoetin Alfa n=244 Participants Participants with anemia in CKD who were on hemodialysis received darbepoetin alfa IV once every two weeks up to 26 weeks and received darbepoetin alfa IV twice the dose than earlier, once every month from Week 27 up to Week 52.	Total n=489 Participants Total of all reporting groups
Age, Continuous	66.2 years STANDARD_DEVIATION 13.64 • n=93 Participants	65.4 years STANDARD_DEVIATION 13.91 • n=4 Participants	65.8 years STANDARD_DEVIATION 13.77 • n=27 Participants
Gender Female	97 Participants n=93 Participants	89 Participants n=4 Participants	186 Participants n=27 Participants
Gender Male	148 Participants n=93 Participants	155 Participants n=4 Participants	303 Participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline (Week -4 to Week -1) and Evaluation period (Weeks 50 to 53)

Population: ITT population included all randomized participants.

Outcome measures

Outcome measures
Measure	MIRCERA n=245 Participants Participants with anemia in CKD who were on hemodialysis received MIRCERA IV once every month up to 52 weeks. The starting dose of MIRCERA administered during the treatment period was dependent on the dose of darbepoetin alfa administered during screening period and was 120, 200 and 360 mcg/month for weekly darbepoetin alfa doses of \<40, 40-80, and \>80 mcg, respectively.	Darbepoetin Alfa n=245 Participants Participants with anemia in CKD who were on hemodialysis received darbepoetin alfa IV once every two weeks up to 26 weeks and received darbepoetin alfa IV twice the dose than earlier, once every month from Week 27 up to Week 52.
Percentage of Participants With Lesser Than or Equal to One Gram Per Deciliter Decrease in Average Hemoglobin From Baseline and Maintaining Average Hemoglobin Level Greater Than or Equal to 10.5 g/dL Over Evaluation Period	64.1 Percentage of participants Interval 57.7 to 70.1	40.4 Percentage of participants Interval 34.2 to 46.8

SECONDARY outcome

Timeframe: Week 27 to Month 12

Population: ITT population included all randomized participants. Data is presented for the participants available at the time of assessment.

All participants received once monthly treatment schedule of both MIRCERA and darbepoetin alpha for the respective treatment arms after Week 27 and these analyses are based on the absolute doses. The average dose in Months 11 and 12 was defined as the mean of all administered doses between study Days 302 and 363. The change in dose was calculated as the percentage change between the respective dose at Week 27 and the average corresponding dose during Months 11 and 12 in each treatment group.

Outcome measures

Outcome measures
Measure	MIRCERA n=211 Participants Participants with anemia in CKD who were on hemodialysis received MIRCERA IV once every month up to 52 weeks. The starting dose of MIRCERA administered during the treatment period was dependent on the dose of darbepoetin alfa administered during screening period and was 120, 200 and 360 mcg/month for weekly darbepoetin alfa doses of \<40, 40-80, and \>80 mcg, respectively.	Darbepoetin Alfa n=219 Participants Participants with anemia in CKD who were on hemodialysis received darbepoetin alfa IV once every two weeks up to 26 weeks and received darbepoetin alfa IV twice the dose than earlier, once every month from Week 27 up to Week 52.
Mean Percentage Change in MIRCERA and Darbepoetin Alpha Dose Over Time	6.8 percent change Standard Deviation 51.0	58.8 percent change Standard Deviation 76.5

SECONDARY outcome

Timeframe: Up to Week 53

Population: The Safety Population was defined as all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not. The 'n' represents the number of participants at a specified time point.

Values of laboratory parameters higher (H) or lower (L) than the Roche defined reference range were considered as abnormality. The laboratory parameters with abnormality were platelets, white blood cells (WBC), albumin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), and potassium. Blood samples were drawn before drug administration and before the dialysis session.

Outcome measures

Outcome measures
Measure	MIRCERA n=242 Participants Participants with anemia in CKD who were on hemodialysis received MIRCERA IV once every month up to 52 weeks. The starting dose of MIRCERA administered during the treatment period was dependent on the dose of darbepoetin alfa administered during screening period and was 120, 200 and 360 mcg/month for weekly darbepoetin alfa doses of \<40, 40-80, and \>80 mcg, respectively.	Darbepoetin Alfa n=243 Participants Participants with anemia in CKD who were on hemodialysis received darbepoetin alfa IV once every two weeks up to 26 weeks and received darbepoetin alfa IV twice the dose than earlier, once every month from Week 27 up to Week 52.
Number of Participants With Marked Laboratory Abnormality Over Time Platelets-H, n = 241, 243	1 participants	5 participants
Number of Participants With Marked Laboratory Abnormality Over Time Platelets-L, n = 241, 243	18 participants	5 participants
Number of Participants With Marked Laboratory Abnormality Over Time WBC-H, n = 242, 243	4 participants	7 participants
Number of Participants With Marked Laboratory Abnormality Over Time WBC-L, n = 242, 243	10 participants	4 participants
Number of Participants With Marked Laboratory Abnormality Over Time ALT-H, n = 241, 242	7 participants	5 participants
Number of Participants With Marked Laboratory Abnormality Over Time ALP-H, n = 240, 242	12 participants	14 participants
Number of Participants With Marked Laboratory Abnormality Over Time AST-H, n = 239, 240	4 participants	6 participants
Number of Participants With Marked Laboratory Abnormality Over Time Albumin-L, n = 240, 242	22 participants	27 participants
Number of Participants With Marked Laboratory Abnormality Over Time Phosphate-H, n = 240, 242	87 participants	92 participants
Number of Participants With Marked Laboratory Abnormality Over Time Phosphate-L, n = 240, 242	36 participants	25 participants
Number of Participants With Marked Laboratory Abnormality Over Time Potassium-H, n = 240, 242	54 participants	41 participants
Number of Participants With Marked Laboratory Abnormality Over Time Potassium-L, n = 240, 242	2 participants	5 participants

SECONDARY outcome

Timeframe: Baseline (Week -4 to Week -1), Week 28, and Week 52

Population: Safety Population included all participants who received at least one dose of MIRCERA or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not. The 'n' represents the number of participants at a specified time point.

Systolic and diastolic blood pressures (BP) were measured before and after the dialysis session at every week from Baseline (Week -4 to Week -1) to Week 53. Median pre-dialysis diastolic blood pressure (PrD DBP) , median post-dialysis diastolic blood pressure (PoD DBP), median pre-dialysis systolic blood pressure (PrD SBP), and post-dialysis systolic blood pressure (PoD SBP) were reported at Baseline (Week -4 to Week -1) , Week 28 and Week 52.

Outcome measures

Outcome measures
Measure	MIRCERA n=245 Participants Participants with anemia in CKD who were on hemodialysis received MIRCERA IV once every month up to 52 weeks. The starting dose of MIRCERA administered during the treatment period was dependent on the dose of darbepoetin alfa administered during screening period and was 120, 200 and 360 mcg/month for weekly darbepoetin alfa doses of \<40, 40-80, and \>80 mcg, respectively.	Darbepoetin Alfa n=244 Participants Participants with anemia in CKD who were on hemodialysis received darbepoetin alfa IV once every two weeks up to 26 weeks and received darbepoetin alfa IV twice the dose than earlier, once every month from Week 27 up to Week 52.
Median Blood Pressure Over Time PrD DBP, Baseline, n = 245, 244	75 millimeter of mercury Interval 32.0 to 139.0	70 millimeter of mercury Interval 34.0 to 206.0
Median Blood Pressure Over Time PrD DBP, Week 28, n = 211, 219	73 millimeter of mercury Interval 42.0 to 118.0	71 millimeter of mercury Interval 39.0 to 107.0
Median Blood Pressure Over Time PrD DBP, Week 52, n = 187, 147	70 millimeter of mercury Interval 21.0 to 107.0	70 millimeter of mercury Interval 39.0 to 101.0
Median Blood Pressure Over Time PoD DBP, Baseline, n = 245, 244	70 millimeter of mercury Interval 33.0 to 113.0	70 millimeter of mercury Interval 30.0 to 132.0
Median Blood Pressure Over Time PoD DBP, Week 28, n = 213, 218	70 millimeter of mercury Interval 26.0 to 101.0	70 millimeter of mercury Interval 30.0 to 127.0
Median Blood Pressure Over Time PoD DBP, Week 52, n = 186, 148	70 millimeter of mercury Interval 18.0 to 107.0	65 millimeter of mercury Interval 33.0 to 107.0
Median Blood Pressure Over Time PrD SBP, Baseline, n = 245, 244	140 millimeter of mercury Interval 83.0 to 206.0	140 millimeter of mercury Interval 75.0 to 241.0
Median Blood Pressure Over Time PrD SBP, Week 28, n = 211, 219	140 millimeter of mercury Interval 89.0 to 219.0	140 millimeter of mercury Interval 62.0 to 199.0
Median Blood Pressure Over Time PrD SBP, Week 52, n = 187, 147	140 millimeter of mercury Interval 85.0 to 195.0	132 millimeter of mercury Interval 84.0 to 195.0
Median Blood Pressure Over Time PoD SBP, Baseline, n = 245, 244	133 millimeter of mercury Interval 83.0 to 215.0	130 millimeter of mercury Interval 61.0 to 248.0
Median Blood Pressure Over Time PoD SBP, Week 28, n = 213, 220	134 millimeter of mercury Interval 73.0 to 228.0	137 millimeter of mercury Interval 71.0 to 200.0
Median Blood Pressure Over Time PoD SBP, Week 52, n = 186, 148	139 millimeter of mercury Interval 90.0 to 204.0	127 millimeter of mercury Interval 70.0 to 198.0

SECONDARY outcome

Timeframe: Baseline (Week -4 to Week -1), Week 28, and Week 52

Population: The Safety population was defined as all participants who received at least one dose of MIRCERA or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not. The 'n' represents the number of participants at a specified time point.

Pulse rate is defined as the number of heartbeats in a minute and was assessed in sitting position of the participants at every week from Baseline (Week -4 to Week -1) to Week 53. Summary data of mean values of pulse rate are presented at Baseline (Week -4 to Week -1), Week 28 and Week 52.

Outcome measures

Outcome measures
Measure	MIRCERA n=245 Participants Participants with anemia in CKD who were on hemodialysis received MIRCERA IV once every month up to 52 weeks. The starting dose of MIRCERA administered during the treatment period was dependent on the dose of darbepoetin alfa administered during screening period and was 120, 200 and 360 mcg/month for weekly darbepoetin alfa doses of \<40, 40-80, and \>80 mcg, respectively.	Darbepoetin Alfa n=244 Participants Participants with anemia in CKD who were on hemodialysis received darbepoetin alfa IV once every two weeks up to 26 weeks and received darbepoetin alfa IV twice the dose than earlier, once every month from Week 27 up to Week 52.
Mean Pulse Rate Over Time Baseline, n = 245, 244	73 beats per minute Standard Deviation 11.1	73 beats per minute Standard Deviation 12.3
Mean Pulse Rate Over Time Week 28, n = 211, 215	74 beats per minute Standard Deviation 13.0	72 beats per minute Standard Deviation 12.6
Mean Pulse Rate Over Time Week 52, n = 184, 147	73 beats per minute Standard Deviation 12.5	71 beats per minute Standard Deviation 11.3

SECONDARY outcome

Timeframe: From screening to Week 56

Population: The Safety Population was defined as all participants who received at least one dose of MIRCERA or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not. Among the 14 deaths in Darbepoetin alfa group, 3 participants died after withdrawal from the study and within 30 days after last dose of study drug.

An adverse event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. A serious adverse event (SAE) is any adverse event that can result in death or is life-threatening or required in participants hospitalization or prolongation of existing hospitalization or results in persistent or significant disability/incapacity; or is a congenital anomaly/birth defect; or is medically significant or requires intervention to prevent one or other of the outcomes listed above. SAEs were reported up to Week 56, while nonserious AEs up to Week 52.

Outcome measures

Outcome measures
Measure	MIRCERA n=245 Participants Participants with anemia in CKD who were on hemodialysis received MIRCERA IV once every month up to 52 weeks. The starting dose of MIRCERA administered during the treatment period was dependent on the dose of darbepoetin alfa administered during screening period and was 120, 200 and 360 mcg/month for weekly darbepoetin alfa doses of \<40, 40-80, and \>80 mcg, respectively.	Darbepoetin Alfa n=244 Participants Participants with anemia in CKD who were on hemodialysis received darbepoetin alfa IV once every two weeks up to 26 weeks and received darbepoetin alfa IV twice the dose than earlier, once every month from Week 27 up to Week 52.
Number of Participants With Any Adverse Events, Serious Adverse Events, and Deaths Participants with any AE	222 Participants	217 Participants
Number of Participants With Any Adverse Events, Serious Adverse Events, and Deaths Participants with any SAE	99 Participants	94 Participants
Number of Participants With Any Adverse Events, Serious Adverse Events, and Deaths Deaths	14 Participants	14 Participants

Adverse Events

MIRCERA

Serious events: 99 serious events

Other events: 140 other events

Deaths: 0 deaths

Darbepoetin Alfa

Serious events: 94 serious events

Other events: 126 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	MIRCERA n=245 participants at risk Participants with anemia in CKD who were on hemodialysis received MIRCERA IV once every month up to 52 weeks. The starting dose of MIRCERA administered during the treatment period was dependent on the dose of darbepoetin alfa administered during screening period and was 120, 200 and 360 mcg/month for weekly darbepoetin alfa doses of \<40, 40-80, and \>80 mcg, respectively.	Darbepoetin Alfa n=244 participants at risk Participants with anemia in CKD who were on hemodialysis received darbepoetin alfa IV once every two weeks up to 26 weeks and received darbepoetin alfa IV twice the dose than earlier, once every month from Week 27 up to Week 52.
Infections and infestations Nasopharyngitis	10.2% 25/245 • Up to Week 56 The Safety Population was defined as all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not. SAEs were reported up to Week 56; however, nonserious AEs were reported up to Week 52 only.	8.2% 20/244 • Up to Week 56 The Safety Population was defined as all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not. SAEs were reported up to Week 56; however, nonserious AEs were reported up to Week 52 only.
Infections and infestations Urinary tract infection	9.4% 23/245 • Up to Week 56 The Safety Population was defined as all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not. SAEs were reported up to Week 56; however, nonserious AEs were reported up to Week 52 only.	6.1% 15/244 • Up to Week 56 The Safety Population was defined as all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not. SAEs were reported up to Week 56; however, nonserious AEs were reported up to Week 52 only.
Infections and infestations Bronchitis	6.9% 17/245 • Up to Week 56 The Safety Population was defined as all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not. SAEs were reported up to Week 56; however, nonserious AEs were reported up to Week 52 only.	6.6% 16/244 • Up to Week 56 The Safety Population was defined as all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not. SAEs were reported up to Week 56; however, nonserious AEs were reported up to Week 52 only.
Infections and infestations Influenza	5.3% 13/245 • Up to Week 56 The Safety Population was defined as all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not. SAEs were reported up to Week 56; however, nonserious AEs were reported up to Week 52 only.	7.0% 17/244 • Up to Week 56 The Safety Population was defined as all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not. SAEs were reported up to Week 56; however, nonserious AEs were reported up to Week 52 only.
Injury, poisoning and procedural complications Procedural hypotension	8.2% 20/245 • Up to Week 56 The Safety Population was defined as all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not. SAEs were reported up to Week 56; however, nonserious AEs were reported up to Week 52 only.	10.7% 26/244 • Up to Week 56 The Safety Population was defined as all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not. SAEs were reported up to Week 56; however, nonserious AEs were reported up to Week 52 only.
Injury, poisoning and procedural complications Arteriovenous fistula site complication	6.5% 16/245 • Up to Week 56 The Safety Population was defined as all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not. SAEs were reported up to Week 56; however, nonserious AEs were reported up to Week 52 only.	6.1% 15/244 • Up to Week 56 The Safety Population was defined as all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not. SAEs were reported up to Week 56; however, nonserious AEs were reported up to Week 52 only.
Gastrointestinal disorders Diarrhoea	6.9% 17/245 • Up to Week 56 The Safety Population was defined as all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not. SAEs were reported up to Week 56; however, nonserious AEs were reported up to Week 52 only.	7.8% 19/244 • Up to Week 56 The Safety Population was defined as all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not. SAEs were reported up to Week 56; however, nonserious AEs were reported up to Week 52 only.
Gastrointestinal disorders Nausea	5.7% 14/245 • Up to Week 56 The Safety Population was defined as all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not. SAEs were reported up to Week 56; however, nonserious AEs were reported up to Week 52 only.	3.3% 8/244 • Up to Week 56 The Safety Population was defined as all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not. SAEs were reported up to Week 56; however, nonserious AEs were reported up to Week 52 only.
Gastrointestinal disorders Constipation	6.5% 16/245 • Up to Week 56 The Safety Population was defined as all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not. SAEs were reported up to Week 56; however, nonserious AEs were reported up to Week 52 only.	1.2% 3/244 • Up to Week 56 The Safety Population was defined as all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not. SAEs were reported up to Week 56; however, nonserious AEs were reported up to Week 52 only.
Musculoskeletal and connective tissue disorders Muscle spasms	8.6% 21/245 • Up to Week 56 The Safety Population was defined as all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not. SAEs were reported up to Week 56; however, nonserious AEs were reported up to Week 52 only.	7.8% 19/244 • Up to Week 56 The Safety Population was defined as all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not. SAEs were reported up to Week 56; however, nonserious AEs were reported up to Week 52 only.
Musculoskeletal and connective tissue disorders Back pain	5.3% 13/245 • Up to Week 56 The Safety Population was defined as all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not. SAEs were reported up to Week 56; however, nonserious AEs were reported up to Week 52 only.	5.3% 13/244 • Up to Week 56 The Safety Population was defined as all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not. SAEs were reported up to Week 56; however, nonserious AEs were reported up to Week 52 only.
Vascular disorders Hypertension	14.3% 35/245 • Up to Week 56 The Safety Population was defined as all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not. SAEs were reported up to Week 56; however, nonserious AEs were reported up to Week 52 only.	10.7% 26/244 • Up to Week 56 The Safety Population was defined as all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not. SAEs were reported up to Week 56; however, nonserious AEs were reported up to Week 52 only.
Metabolism and nutrition disorders Fluid overload	3.7% 9/245 • Up to Week 56 The Safety Population was defined as all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not. SAEs were reported up to Week 56; however, nonserious AEs were reported up to Week 52 only.	6.6% 16/244 • Up to Week 56 The Safety Population was defined as all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta or darbepoetin alfa and had a safety follow-up, whether withdrawn prematurely or not. SAEs were reported up to Week 56; however, nonserious AEs were reported up to Week 52 only.

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