Trial Outcomes & Findings for An Observational Study of Mircera (Methoxy Polyethylene Glycol-epoetin Beta) in Anemic Patients With Chronic Kidney Disease (NORM) (NCT NCT01417377)

Results Overview

Recruitment status

COMPLETED

Target enrollment

22 participants

Primary outcome timeframe

Month 4 up to Month 6

Results posted on

2017-07-13

Participant Flow

Participant milestones

Participant milestones
Measure	Mircera Participants with chronic kidney disease receiving methoxy polyethylene glycol-epoetin beta (Mircera) and previously on treatment with short-acting epoetin alpha were observed for a period of 6 months.
Overall Study STARTED	22
Overall Study Treated	21
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Mircera Participants with chronic kidney disease receiving methoxy polyethylene glycol-epoetin beta (Mircera) and previously on treatment with short-acting epoetin alpha were observed for a period of 6 months.
Overall Study Lost to Follow-up	12
Overall Study Enrolled, but not treated	1

Baseline Characteristics

An Observational Study of Mircera (Methoxy Polyethylene Glycol-epoetin Beta) in Anemic Patients With Chronic Kidney Disease (NORM)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mircera n=22 Participants Participants with chronic kidney disease receiving methoxy polyethylene glycol-epoetin beta (Mircera) and previously on treatment with short-acting epoetin alpha were observed for a period of 6 months.
Age, Continuous	55.2 years STANDARD_DEVIATION 16.8 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants

PRIMARY outcome

Timeframe: Month 4 up to Month 6

Population: None of the enrolled participants in the study achieved Hb level between 11 to 12 g/dL during the final 2 months of study, therefore this particular endpoint was not analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 6 months

Population: None of the enrolled participants in the study achieved Hb level between 11 to 12 g/dL during the final 2 months of study, therefore this particular endpoint was not analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 6 months

Population: None of the enrolled participants in the study achieved Hb level between 11 to 12 g/dL during the final 2 months of study, therefore this particular endpoint was not analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 6 months

Population: The number of doses were not collected because the participants never achieved Hb level of 11 to 12 g/dL.

Outcome measures

Outcome data not reported

Adverse Events

Mircera

Serious events: 3 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Mircera n=22 participants at risk Participants with chronic kidney disease receiving methoxy polyethylene glycol-epoetin beta (Mircera) and previously on treatment with short-acting epoetin alpha were observed for a period of 6 months.
Respiratory, thoracic and mediastinal disorders Cardio-respiratory arrest	13.6% 3/22 • Up to 6 months

Other adverse events

Other adverse events
Measure	Mircera n=22 participants at risk Participants with chronic kidney disease receiving methoxy polyethylene glycol-epoetin beta (Mircera) and previously on treatment with short-acting epoetin alpha were observed for a period of 6 months.
Gastrointestinal disorders Diarrhoea	13.6% 3/22 • Up to 6 months
Gastrointestinal disorders Nausea	22.7% 5/22 • Up to 6 months
Gastrointestinal disorders Gastroenteritis	9.1% 2/22 • Up to 6 months
Respiratory, thoracic and mediastinal disorders Bronchitis	9.1% 2/22 • Up to 6 months
Respiratory, thoracic and mediastinal disorders Cough	9.1% 2/22 • Up to 6 months
Musculoskeletal and connective tissue disorders Back pain	9.1% 2/22 • Up to 6 months
Nervous system disorders Headache	13.6% 3/22 • Up to 6 months
Vascular disorders Hypertension	9.1% 2/22 • Up to 6 months
Vascular disorders Hypotension	13.6% 3/22 • Up to 6 months

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