Trial Outcomes & Findings for A Study of Once Monthly Subcutaneous Mircera in Patients With Chronic Renal Anemia Not on Dialysis (NCT NCT00922116)
NCT ID: NCT00922116
Last Updated: 2017-07-13
Results Overview
The target hemoglobin was defined as the mean of the three assessments recorded at Weeks -4, -2, and 0 (Stability Verification Period \[SVP\]). EEP was an 8 week period from Weeks 17 to 24. The 95 percent (%) confidence interval (CI) was estimated using Clopper-Pearson.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
191 participants
Primary outcome timeframe
EEP (Weeks 17 to 24)
Results posted on
2017-07-13
Participant Flow
Participant milestones
| Measure |
Mircera
Participants received Mircera (methoxy polyethylene glycol epoetin beta) at a starting dose of 120, 200 or 360 micrograms \[mcg\] (based on previous erythropoiesis stimulating agent therapy) administered via subcutaneous (SC) injection once monthly for 24 weeks. Doses were titrated based on hemoglobin levels.
|
|---|---|
|
Overall Study
STARTED
|
191
|
|
Overall Study
COMPLETED
|
176
|
|
Overall Study
NOT COMPLETED
|
15
|
Reasons for withdrawal
| Measure |
Mircera
Participants received Mircera (methoxy polyethylene glycol epoetin beta) at a starting dose of 120, 200 or 360 micrograms \[mcg\] (based on previous erythropoiesis stimulating agent therapy) administered via subcutaneous (SC) injection once monthly for 24 weeks. Doses were titrated based on hemoglobin levels.
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|---|---|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Death
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Other
|
5
|
Baseline Characteristics
A Study of Once Monthly Subcutaneous Mircera in Patients With Chronic Renal Anemia Not on Dialysis
Baseline characteristics by cohort
| Measure |
Mircera
n=191 Participants
Participants received Mircera (methoxy polyethylene glycol epoetin beta) at a starting dose of 120, 200 or 360 mcg (based on previous erythropoiesis stimulating agent therapy) administered via SC injection once monthly for 24 weeks. Doses were titrated based on hemoglobin levels.
|
|---|---|
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Age, Continuous
|
60.4 years
STANDARD_DEVIATION 12.9 • n=99 Participants
|
|
Sex: Female, Male
Female
|
114 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
77 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: EEP (Weeks 17 to 24)Population: Intention-to-Treat (ITT) population included all participants who received one more dose of Mircera.
The target hemoglobin was defined as the mean of the three assessments recorded at Weeks -4, -2, and 0 (Stability Verification Period \[SVP\]). EEP was an 8 week period from Weeks 17 to 24. The 95 percent (%) confidence interval (CI) was estimated using Clopper-Pearson.
Outcome measures
| Measure |
Mircera
n=187 Participants
Participants received Mircera (methoxy polyethylene glycol epoetin beta) at a starting dose of 120, 200 or 360 mcg (based on previous erythropoiesis stimulating agent therapy) administered via SC injection once monthly for 24 weeks. Doses were titrated based on hemoglobin levels.
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|---|---|
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Percentage of Participants Maintaining Average Hemoglobin Concentration Within the Target Range During the Efficacy Evaluable Period (EEP)
|
53.9 percentage of participants
Interval 46.3 to 61.4
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SECONDARY outcome
Timeframe: SVP (Baseline), and EEP (Weeks 17 to 24)Population: ITT population.
Baseline hemoglobin was defined as the mean of the three assessments recorded at Weeks -4, -2, and 0 (SVP). EEP hemoglobin was defined as the mean of the hemoglobin assessments during EEP. EEP was an 8 week period from Weeks 17 to 24.
Outcome measures
| Measure |
Mircera
n=187 Participants
Participants received Mircera (methoxy polyethylene glycol epoetin beta) at a starting dose of 120, 200 or 360 mcg (based on previous erythropoiesis stimulating agent therapy) administered via SC injection once monthly for 24 weeks. Doses were titrated based on hemoglobin levels.
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|---|---|
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Change in Hemoglobin Concentration Between SVP and the EEP
|
0.55 grams per deciliter (g/dL)
Standard Deviation 0.93
|
SECONDARY outcome
Timeframe: EEP (Weeks 17 to 24)Population: ITT population.
EEP was an 8 week period from Weeks 17 to 24. The 95% CI was estimated using Clopper-Pearson.
Outcome measures
| Measure |
Mircera
n=187 Participants
Participants received Mircera (methoxy polyethylene glycol epoetin beta) at a starting dose of 120, 200 or 360 mcg (based on previous erythropoiesis stimulating agent therapy) administered via SC injection once monthly for 24 weeks. Doses were titrated based on hemoglobin levels.
|
|---|---|
|
Percentage of Participants Maintaining Hemoglobin Concentration Within Hemoglobin Range 10.0 to 12.0 g/dL Throughout the EEP
|
73.0 percentage of participants
Interval 65.9 to 79.4
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SECONDARY outcome
Timeframe: Weeks 1 to 24Population: ITT population.
DTP was a 16- week period from Week 1 to Week 16, EEP was an 8-week period from Weeks 17 to 24. Dose adjustment was assessed during entire Week 1 to 24.
Outcome measures
| Measure |
Mircera
n=187 Participants
Participants received Mircera (methoxy polyethylene glycol epoetin beta) at a starting dose of 120, 200 or 360 mcg (based on previous erythropoiesis stimulating agent therapy) administered via SC injection once monthly for 24 weeks. Doses were titrated based on hemoglobin levels.
|
|---|---|
|
Percentage of Participants Who Required Dose Adjustments During Dose Titration Period (DTP) and EEP
|
87.2 percentage of participants
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SECONDARY outcome
Timeframe: Weeks 1 to 24Population: ITT population. Here number of participants analyzed = participants who were analyzed for the outcome measure.
DTP was a 16- week period from Week 1 to Week 16, EEP was an 8-week period from Weeks 17 to 24. Dose adjustment was assessed during entire Week 1 to 24.
Outcome measures
| Measure |
Mircera
n=158 Participants
Participants received Mircera (methoxy polyethylene glycol epoetin beta) at a starting dose of 120, 200 or 360 mcg (based on previous erythropoiesis stimulating agent therapy) administered via SC injection once monthly for 24 weeks. Doses were titrated based on hemoglobin levels.
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|---|---|
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Time Spent in Hemoglobin Range of 10.0 to 12.0 g/dL During DTP and EEP
|
103.6 days
Standard Deviation 41.9
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SECONDARY outcome
Timeframe: Weeks 0-4, 4-8, 8-12, 12-16, 16-20, and 20-24Population: ITT population. Here number of participants analyzed = participants who were analyzed for the outcome measure.
Outcome measures
| Measure |
Mircera
n=145 Participants
Participants received Mircera (methoxy polyethylene glycol epoetin beta) at a starting dose of 120, 200 or 360 mcg (based on previous erythropoiesis stimulating agent therapy) administered via SC injection once monthly for 24 weeks. Doses were titrated based on hemoglobin levels.
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|---|---|
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Average Dose of Mircera Per Month
Week 0-4
|
121.2 microgram (mcg)
Standard Deviation 9.8
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|
Average Dose of Mircera Per Month
Week 4-8
|
100.8 microgram (mcg)
Standard Deviation 33.3
|
|
Average Dose of Mircera Per Month
Week 8-12
|
78.8 microgram (mcg)
Standard Deviation 45.8
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Average Dose of Mircera Per Month
Week 12-16
|
72.7 microgram (mcg)
Standard Deviation 46.6
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Average Dose of Mircera Per Month
Week 16-20
|
66.9 microgram (mcg)
Standard Deviation 48.0
|
|
Average Dose of Mircera Per Month
Week 20-24
|
66.2 microgram (mcg)
Standard Deviation 47.1
|
Adverse Events
Mircera
Serious events: 31 serious events
Other events: 90 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Mircera
n=191 participants at risk
Participants received Mircera (methoxy polyethylene glycol epoetin beta) at a starting dose of 120, 200 or 360 mcg (based on previous erythropoiesis stimulating agent therapy) administered via SC injection once monthly for 24 weeks. Doses were titrated based on hemoglobin levels.
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|---|---|
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Cardiac disorders
Ischaemic cardiomyopathy
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0.52%
1/191 • up to Week 28
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.52%
1/191 • up to Week 28
|
|
Eye disorders
Glaucoma
|
0.52%
1/191 • up to Week 28
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.52%
1/191 • up to Week 28
|
|
General disorders
Asthenia
|
0.52%
1/191 • up to Week 28
|
|
General disorders
Fatigue
|
0.52%
1/191 • up to Week 28
|
|
General disorders
Generalised oedema
|
0.52%
1/191 • up to Week 28
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.52%
1/191 • up to Week 28
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.52%
1/191 • up to Week 28
|
|
Infections and infestations
Appendicitis
|
0.52%
1/191 • up to Week 28
|
|
Infections and infestations
Cellulitis
|
0.52%
1/191 • up to Week 28
|
|
Infections and infestations
Herpes zoster
|
0.52%
1/191 • up to Week 28
|
|
Infections and infestations
Pneumonia
|
0.52%
1/191 • up to Week 28
|
|
Infections and infestations
Sepsis
|
0.52%
1/191 • up to Week 28
|
|
Infections and infestations
Upper respiratory tract infection
|
0.52%
1/191 • up to Week 28
|
|
Infections and infestations
Wound infection
|
0.52%
1/191 • up to Week 28
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.52%
1/191 • up to Week 28
|
|
Metabolism and nutrition disorders
Gout
|
0.52%
1/191 • up to Week 28
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.52%
1/191 • up to Week 28
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.52%
1/191 • up to Week 28
|
|
Nervous system disorders
Dizziness
|
1.0%
2/191 • up to Week 28
|
|
Renal and urinary disorders
Azotaemia
|
0.52%
1/191 • up to Week 28
|
|
Renal and urinary disorders
Calculus ureteric
|
0.52%
1/191 • up to Week 28
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.52%
1/191 • up to Week 28
|
|
Renal and urinary disorders
Renal failure chronic
|
6.3%
12/191 • up to Week 28
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.52%
1/191 • up to Week 28
|
Other adverse events
| Measure |
Mircera
n=191 participants at risk
Participants received Mircera (methoxy polyethylene glycol epoetin beta) at a starting dose of 120, 200 or 360 mcg (based on previous erythropoiesis stimulating agent therapy) administered via SC injection once monthly for 24 weeks. Doses were titrated based on hemoglobin levels.
|
|---|---|
|
General disorders
Oedema
|
8.4%
16/191 • up to Week 28
|
|
Infections and infestations
Nasopharyngitis
|
8.9%
17/191 • up to Week 28
|
|
Infections and infestations
Upper respiratory tract infection
|
10.5%
20/191 • up to Week 28
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
6.3%
12/191 • up to Week 28
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.2%
10/191 • up to Week 28
|
|
Vascular disorders
Hypertension
|
7.9%
15/191 • up to Week 28
|
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