Trial Outcomes & Findings for An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) as Maintenance Treatment in Patients With Chronic Renal Anemia on Haemodialysis (NCT NCT01422824)

Last Updated: 2016-03-28

Results Overview

AE: any unfavorable and unintended sign, symptom, or disease associated with use of study drug, regardless of relation to study drug. Pre-existing conditions that worsened and laboratory or clinical tests that resulted in change in treatment or discontinuation from study drug were reported as AEs. Serious AE (SAE): resulted in death, life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was congenital anomaly/birth defect, or was medically significant. Any AE included participants with both serious and non-serious AEs.

Recruitment status

COMPLETED

Target enrollment

185 participants

Primary outcome timeframe

Up to 12 months

Results posted on

2016-03-28

Participant Flow

Participant milestones

Participant milestones
Measure	Mircera Participants received Mircera® (methoxy polyethylene glycol-epoetin beta) according to the standard practice in line with current summaries of product characteristics (SPCs)/local labeling.
Overall Study STARTED	185
Overall Study Treated	184
Overall Study COMPLETED	147
Overall Study NOT COMPLETED	38

Reasons for withdrawal

Reasons for withdrawal
Measure	Mircera Participants received Mircera® (methoxy polyethylene glycol-epoetin beta) according to the standard practice in line with current summaries of product characteristics (SPCs)/local labeling.
Overall Study Case record form not evaluated	1
Overall Study Lost to Follow-up	37

Baseline Characteristics

An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) as Maintenance Treatment in Patients With Chronic Renal Anemia on Haemodialysis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mircera n=184 Participants Participants received Mircera® (methoxy polyethylene glycol-epoetin beta) according to the standard practice in line with current SPCs/local labeling.
Age, Continuous	58.0 years STANDARD_DEVIATION 10.9 • n=5 Participants
Sex: Female, Male Female	78 Participants n=5 Participants
Sex: Female, Male Male	106 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 12 months

Population: Safety population

Outcome measures

Outcome measures
Measure	Mircera n=184 Participants Participants received Mircera® (methoxy polyethylene glycol-epoetin beta) according to the standard practice in line with current SPCs/local labeling.
Number of Participants With Adverse Events (AEs) Any AE	49 participants
Number of Participants With Adverse Events (AEs) SAE	22 participants

SECONDARY outcome

Timeframe: Baseline; Weeks 8, 16, 24, 48

Population: Efficacy intent-to-treat population included all treated participants. Here, 'n' signifies the number of participants with available data for hemoglobin at specified visits.

Outcome measures

Outcome measures
Measure	Mircera n=184 Participants Participants received Mircera® (methoxy polyethylene glycol-epoetin beta) according to the standard practice in line with current SPCs/local labeling.
Hemoglobin Levels Baseline (n=184)	110.3 gram per liter Standard Deviation 8.671274
Hemoglobin Levels Week 8 (n=179)	110.8 gram per liter Standard Deviation 13.31517
Hemoglobin Levels Week 16 (n=155)	111.3 gram per liter Standard Deviation 14.97250
Hemoglobin Levels Week 24 (n=161)	111.2 gram per liter Standard Deviation 14.93382
Hemoglobin Levels Week 48 (n=130)	111.2 gram per liter Standard Deviation 13.5594

Adverse Events

Mircera

Serious events: 22 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Mircera n=184 participants at risk Participants received Mircera® (methoxy polyethylene glycol-epoetin beta) according to the standard practice in line with current SPCs/local labeling.
Blood and lymphatic system disorders Decreased hemoglobin	0.54% 1/184 • Up to 12 months Safety population.
Cardiac disorders Myocardial infarction	2.2% 4/184 • Up to 12 months Safety population.
Cardiac disorders Chest pain - cardiac	0.54% 1/184 • Up to 12 months Safety population.
Gastrointestinal disorders Hemorrhoidal hemorrhage	0.54% 1/184 • Up to 12 months Safety population.
Gastrointestinal disorders Colitis	0.54% 1/184 • Up to 12 months Safety population.
General disorders Death	2.7% 5/184 • Up to 12 months Safety population.
Hepatobiliary disorders Cholecystitis	0.54% 1/184 • Up to 12 months Safety population.
Injury, poisoning and procedural complications Vascular access thrombosis	0.54% 1/184 • Up to 12 months Safety population.
Musculoskeletal and connective tissue disorders Arthralgia	0.54% 1/184 • Up to 12 months Safety population.
Renal and urinary disorders Hematuria	0.54% 1/184 • Up to 12 months Safety population.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.54% 1/184 • Up to 12 months Safety population.
Respiratory, thoracic and mediastinal disorders Epistaxis with melena	0.54% 1/184 • Up to 12 months Safety population.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.54% 1/184 • Up to 12 months Safety population.
Vascular disorders Thromboembolic event	1.1% 2/184 • Up to 12 months Safety population.

Other adverse events

Other adverse events
Measure	Mircera n=184 participants at risk Participants received Mircera® (methoxy polyethylene glycol-epoetin beta) according to the standard practice in line with current SPCs/local labeling.
Musculoskeletal and connective tissue disorders Arthralgia	7.6% 14/184 • Up to 12 months Safety population.

Additional Information

Medical Communications

Hoffmann-LaRoche

Phone: 800 821-8590

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