Trial Outcomes & Findings for A Study of Subcutaneous Mircera for the Maintenance Treatment of Participants With Chronic Renal Anemia (NCT NCT00642668)
NCT ID: NCT00642668
Last Updated: 2017-07-05
Results Overview
The EEP was week 29 through week 36. The target range for average hemoglobin concentration was 10.0 - 12.0 g/dL.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
35 participants
Primary outcome timeframe
Weeks 29-36
Results posted on
2017-07-05
Participant Flow
Participant milestones
| Measure |
Methoxy Polyethylene Glycol-Epoetin Beta
Participants received methoxy polyethylene glycol-epoetin beta treatment monthly for 36 weeks with an efficacy evaluation period (EEP) during weeks 29-36 and followed by a 4 week follow-up period.
methoxy polyethylene glycol-epoetin beta: 1.2 mcg/kg administered subcutaneously (sc) monthly for 36 weeks (initial recommended dose)
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|---|---|
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Overall Study
STARTED
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35
|
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Overall Study
COMPLETED
|
21
|
|
Overall Study
NOT COMPLETED
|
14
|
Reasons for withdrawal
| Measure |
Methoxy Polyethylene Glycol-Epoetin Beta
Participants received methoxy polyethylene glycol-epoetin beta treatment monthly for 36 weeks with an efficacy evaluation period (EEP) during weeks 29-36 and followed by a 4 week follow-up period.
methoxy polyethylene glycol-epoetin beta: 1.2 mcg/kg administered subcutaneously (sc) monthly for 36 weeks (initial recommended dose)
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|---|---|
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Overall Study
Lost to Follow-up
|
1
|
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Overall Study
Adverse Event
|
2
|
|
Overall Study
Death
|
2
|
|
Overall Study
Insufficient Therapeutic Response
|
1
|
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Overall Study
Failure to Return
|
1
|
|
Overall Study
Dialysis Initiation
|
5
|
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Overall Study
Blood Transfusion
|
2
|
Baseline Characteristics
A Study of Subcutaneous Mircera for the Maintenance Treatment of Participants With Chronic Renal Anemia
Baseline characteristics by cohort
| Measure |
Methoxy Polyethylene Glycol-Epoetin Beta
n=34 Participants
Participants received methoxy polyethylene glycol-epoetin beta treatment monthly for 36 weeks with an efficacy evaluation period (EEP) during weeks 29-36 and followed by a 4 week follow-up period.
methoxy polyethylene glycol-epoetin beta: 1.2 mcg/kg administered subcutaneously (sc) monthly for 36 weeks (initial recommended dose)
|
|---|---|
|
Age, Continuous
|
77 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
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Sex: Female, Male
Male
|
24 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Weeks 29-36Population: Intent-to-Treat (ITT) population included all participants who entered the titration period and received active drug.
The EEP was week 29 through week 36. The target range for average hemoglobin concentration was 10.0 - 12.0 g/dL.
Outcome measures
| Measure |
Methoxy Polyethylene Glycol-Epoetin Beta
n=34 Participants
Participants received methoxy polyethylene glycol-epoetin beta treatment monthly for 36 weeks with an efficacy evaluation period (EEP) during weeks 29-36 and followed by a 4 week follow-up period.
methoxy polyethylene glycol-epoetin beta: 1.2 mcg/kg administered subcutaneously (sc) monthly for 36 weeks (initial recommended dose)
|
|---|---|
|
Percentage of Participants Maintaining Average Hemoglobin Concentration During Efficacy Evaluation Period (EEP) Within Target Range
|
41 percentage of participants
Interval 24.7 to 59.3
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SECONDARY outcome
Timeframe: Weeks 0-36Population: ITT population included all participants who entered the titration period and received active drug.
The mean change Baseline Hemoglobin to the time adjusted average of Hemoglobin during the EEP.
Outcome measures
| Measure |
Methoxy Polyethylene Glycol-Epoetin Beta
n=34 Participants
Participants received methoxy polyethylene glycol-epoetin beta treatment monthly for 36 weeks with an efficacy evaluation period (EEP) during weeks 29-36 and followed by a 4 week follow-up period.
methoxy polyethylene glycol-epoetin beta: 1.2 mcg/kg administered subcutaneously (sc) monthly for 36 weeks (initial recommended dose)
|
|---|---|
|
Change From Baseline in Hemoglobin Concentration to Efficacy Evaluation Period (EEP)
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0.99 grams/deciliter (g/dL)
Standard Deviation 1.38
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SECONDARY outcome
Timeframe: Weeks 29-36Population: ITT population included all participants who entered the titration period and received active drug.
Outcome measures
| Measure |
Methoxy Polyethylene Glycol-Epoetin Beta
n=34 Participants
Participants received methoxy polyethylene glycol-epoetin beta treatment monthly for 36 weeks with an efficacy evaluation period (EEP) during weeks 29-36 and followed by a 4 week follow-up period.
methoxy polyethylene glycol-epoetin beta: 1.2 mcg/kg administered subcutaneously (sc) monthly for 36 weeks (initial recommended dose)
|
|---|---|
|
Percentage of Participants Maintaining Hemoglobin Concentrations Within Range of 10-12 Grams/Deciliter (g/dL) Throughout Efficacy Evaluation Period (EEP)
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23.5 percentage of participants
Interval 10.8 to 41.2
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SECONDARY outcome
Timeframe: Weeks 29-36Population: ITT population included all participants who entered the titration period and received active drug.
Outcome measures
| Measure |
Methoxy Polyethylene Glycol-Epoetin Beta
n=34 Participants
Participants received methoxy polyethylene glycol-epoetin beta treatment monthly for 36 weeks with an efficacy evaluation period (EEP) during weeks 29-36 and followed by a 4 week follow-up period.
methoxy polyethylene glycol-epoetin beta: 1.2 mcg/kg administered subcutaneously (sc) monthly for 36 weeks (initial recommended dose)
|
|---|---|
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Mean Time Spent in Hemoglobin Range of 10-12 g/dL During Efficacy Evaluation Period (EEP)
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28.6 days
Standard Deviation 21.2
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SECONDARY outcome
Timeframe: Weeks 1-40Population: The safety population included all participants who received at least one dose of active drug.
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore 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. Preexisting conditions which worsen during a study are also considered as adverse events.
Outcome measures
| Measure |
Methoxy Polyethylene Glycol-Epoetin Beta
n=34 Participants
Participants received methoxy polyethylene glycol-epoetin beta treatment monthly for 36 weeks with an efficacy evaluation period (EEP) during weeks 29-36 and followed by a 4 week follow-up period.
methoxy polyethylene glycol-epoetin beta: 1.2 mcg/kg administered subcutaneously (sc) monthly for 36 weeks (initial recommended dose)
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|---|---|
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Percentage of Participants With Adverse Events
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97 percentage of participants
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Adverse Events
Methoxy Polyethylene Glycol-Epoetin Beta
Serious events: 15 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Methoxy Polyethylene Glycol-Epoetin Beta
n=34 participants at risk
Participants received methoxy polyethylene glycol-epoetin beta treatment monthly for 36 weeks with an efficacy evaluation period (EEP) during weeks 29-36 and followed by a 4 week follow-up period.
methoxy polyethylene glycol-epoetin beta: 1.2 mcg/kg administered subcutaneously (sc) monthly for 36 weeks (initial recommended dose)
|
|---|---|
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Blood and lymphatic system disorders
Anaemia
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5.9%
2/34 • Weeks 1-40
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Blood and lymphatic system disorders
Pancytopenia
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2.9%
1/34 • Weeks 1-40
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Cardiac disorders
Cardiac arrest
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2.9%
1/34 • Weeks 1-40
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Cardiac disorders
Cardiac failure
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5.9%
2/34 • Weeks 1-40
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|
Cardiac disorders
Cardiac failure congestive
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2.9%
1/34 • Weeks 1-40
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|
Cardiac disorders
Myocardial infarction
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2.9%
1/34 • Weeks 1-40
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|
Gastrointestinal disorders
Diarrhoea
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2.9%
1/34 • Weeks 1-40
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|
Gastrointestinal disorders
Oesophagitis
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2.9%
1/34 • Weeks 1-40
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|
General disorders
Administration related reaction
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2.9%
1/34 • Weeks 1-40
|
|
General disorders
Asthenia
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2.9%
1/34 • Weeks 1-40
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|
General disorders
Medical device complication
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2.9%
1/34 • Weeks 1-40
|
|
General disorders
Pyrexia
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2.9%
1/34 • Weeks 1-40
|
|
General disorders
Sudden cardiac death
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2.9%
1/34 • Weeks 1-40
|
|
Hepatobiliary disorders
Hepatic cirrhosis
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2.9%
1/34 • Weeks 1-40
|
|
Infections and infestations
Diarrhoea infectious
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2.9%
1/34 • Weeks 1-40
|
|
Infections and infestations
Gastroenteritis
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2.9%
1/34 • Weeks 1-40
|
|
Infections and infestations
Pseudomembranous colitis
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2.9%
1/34 • Weeks 1-40
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|
Infections and infestations
Urinary tract infection
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2.9%
1/34 • Weeks 1-40
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|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
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2.9%
1/34 • Weeks 1-40
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|
Nervous system disorders
Carotid artery stenosis
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2.9%
1/34 • Weeks 1-40
|
|
Renal and urinary disorders
Renal failure acute
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2.9%
1/34 • Weeks 1-40
|
|
Renal and urinary disorders
Renal failure chronic
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5.9%
2/34 • Weeks 1-40
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
2.9%
1/34 • Weeks 1-40
|
|
Vascular disorders
Extremity necrosis
|
2.9%
1/34 • Weeks 1-40
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Other adverse events
| Measure |
Methoxy Polyethylene Glycol-Epoetin Beta
n=34 participants at risk
Participants received methoxy polyethylene glycol-epoetin beta treatment monthly for 36 weeks with an efficacy evaluation period (EEP) during weeks 29-36 and followed by a 4 week follow-up period.
methoxy polyethylene glycol-epoetin beta: 1.2 mcg/kg administered subcutaneously (sc) monthly for 36 weeks (initial recommended dose)
|
|---|---|
|
Cardiac disorders
Atrial fibrillation
|
8.8%
3/34 • Weeks 1-40
|
|
Gastrointestinal disorders
Diarrhoea
|
5.9%
2/34 • Weeks 1-40
|
|
Gastrointestinal disorders
Gastric ulcer
|
5.9%
2/34 • Weeks 1-40
|
|
Gastrointestinal disorders
Nausea
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5.9%
2/34 • Weeks 1-40
|
|
Gastrointestinal disorders
Oesophagitis
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5.9%
2/34 • Weeks 1-40
|
|
General disorders
Chest pain
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5.9%
2/34 • Weeks 1-40
|
|
General disorders
Fatigue
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14.7%
5/34 • Weeks 1-40
|
|
General disorders
Oedema
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11.8%
4/34 • Weeks 1-40
|
|
Infections and infestations
Bronchitis
|
17.6%
6/34 • Weeks 1-40
|
|
Infections and infestations
Gastroenteritis
|
5.9%
2/34 • Weeks 1-40
|
|
Infections and infestations
Nasopharyngitis
|
8.8%
3/34 • Weeks 1-40
|
|
Injury, poisoning and procedural complications
Fall
|
8.8%
3/34 • Weeks 1-40
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
5.9%
2/34 • Weeks 1-40
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.9%
2/34 • Weeks 1-40
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.8%
3/34 • Weeks 1-40
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.9%
2/34 • Weeks 1-40
|
|
Nervous system disorders
Headache
|
5.9%
2/34 • Weeks 1-40
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.9%
2/34 • Weeks 1-40
|
|
Vascular disorders
Hypertension
|
44.1%
15/34 • Weeks 1-40
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Additional Information
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