Trial Outcomes & Findings for A Study of Monthly Subcutaneous Continuous Erythropoietin Receptor Activator (CERA) in Predialysis Participants With Chronic Renal Anemia (NCT NCT00773968)
NCT ID: NCT00773968
Last Updated: 2016-04-04
Results Overview
The reference Hb was defined as the average Hb concentration calculated on the basis of all Hb assessments taken at Weeks -4, -2, and 0 (before the first dose administration).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
140 participants
Primary outcome timeframe
EEP: Weeks 17 to 28
Results posted on
2016-04-04
Participant Flow
Participant milestones
| Measure |
Methoxy Polyethylene Glycol-Epoetin Beta
Participants received methoxy polyethylene glycol-epoetin beta (also known as continuous erythropoietin receptor activator \[CERA\]) once monthly by subcutaneous (SC) injection, for 28 weeks. The initial dose of methoxy polyethylene glycol-epoetin beta was 120 or 200 or 360 micrograms (µg) if the last weekly dose of previous erythropoietin stimulating agent (ESA) (darbepoetin alfa) was less than (\<) 40 µg or 40-80 µg or greater than (\>) 80 µg, respectively. The doses were adjusted according to individual participant's hemoglobin (Hb) value.
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|---|---|
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Overall Study
STARTED
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140
|
|
Overall Study
Treated
|
111
|
|
Overall Study
COMPLETED
|
95
|
|
Overall Study
NOT COMPLETED
|
45
|
Reasons for withdrawal
| Measure |
Methoxy Polyethylene Glycol-Epoetin Beta
Participants received methoxy polyethylene glycol-epoetin beta (also known as continuous erythropoietin receptor activator \[CERA\]) once monthly by subcutaneous (SC) injection, for 28 weeks. The initial dose of methoxy polyethylene glycol-epoetin beta was 120 or 200 or 360 micrograms (µg) if the last weekly dose of previous erythropoietin stimulating agent (ESA) (darbepoetin alfa) was less than (\<) 40 µg or 40-80 µg or greater than (\>) 80 µg, respectively. The doses were adjusted according to individual participant's hemoglobin (Hb) value.
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|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Death
|
1
|
|
Overall Study
Failure to Return
|
2
|
|
Overall Study
Lack of Efficacy
|
3
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Withdrawal by Subject
|
11
|
|
Overall Study
Screen Failure
|
17
|
|
Overall Study
Other
|
8
|
Baseline Characteristics
A Study of Monthly Subcutaneous Continuous Erythropoietin Receptor Activator (CERA) in Predialysis Participants With Chronic Renal Anemia
Baseline characteristics by cohort
| Measure |
Methoxy Polyethylene Glycol-Epoetin Beta
n=111 Participants
Participants received methoxy polyethylene glycol-epoetin beta once monthly by SC injection, for 28 weeks. The initial dose of methoxy polyethylene glycol-epoetin beta was 120 or 200 or 360 µg if the last weekly dose of previous ESA (darbepoetin alfa) was \<40 µg or 40-80 µg or \>80 µg, respectively. The doses were adjusted according to individual participant's Hb value.
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|---|---|
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Age, Continuous
|
68.1 years
STANDARD_DEVIATION 13.49 • n=5 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: EEP: Weeks 17 to 28Population: Per protocol population included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta and for whom the data for at least one follow-up variable were available and were without any major protocol violation.
The reference Hb was defined as the average Hb concentration calculated on the basis of all Hb assessments taken at Weeks -4, -2, and 0 (before the first dose administration).
Outcome measures
| Measure |
Methoxy Polyethylene Glycol-Epoetin Beta
n=41 Participants
Participants received methoxy polyethylene glycol-epoetin beta once monthly by SC injection, for 28 weeks. The initial dose of methoxy polyethylene glycol-epoetin beta was 120 or 200 or 360 µg if the last weekly dose of previous ESA (darbepoetin alfa) was \<40 µg or 40-80 µg or \>80 µg, respectively. The doses were adjusted according to individual participant's Hb value.
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|---|---|
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Percentage of Participants Maintaining Their Mean Hb Concentration Within Plus/Minus (±) 1 Grams Per Deciliter (g/dL) of the Reference Range and Between 10.0 and 12.0 g/dL During Efficacy Evaluation Period (EEP)
|
65.85 percentage of participants
Interval 49.41 to 79.92
|
SECONDARY outcome
Timeframe: SVP: Week -4 to Week 0; EEP: Weeks 17 to 28Population: Per protocol population.
Hb concentrations during SVP were the reference Hb concentrations. For each assessment period (SVP and EEP) the average Hb concentration was calculated on the basis of all Hb assessments taken during the assessment period. Change in average Hb concentration from reference range (SVP) was calculated.
Outcome measures
| Measure |
Methoxy Polyethylene Glycol-Epoetin Beta
n=41 Participants
Participants received methoxy polyethylene glycol-epoetin beta once monthly by SC injection, for 28 weeks. The initial dose of methoxy polyethylene glycol-epoetin beta was 120 or 200 or 360 µg if the last weekly dose of previous ESA (darbepoetin alfa) was \<40 µg or 40-80 µg or \>80 µg, respectively. The doses were adjusted according to individual participant's Hb value.
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|---|---|
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Change in Hb Concentrations Between EEP and Stability Verification Period (SVP)
|
0.27 g/dL
Standard Deviation 0.73
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SECONDARY outcome
Timeframe: EEP: Weeks 17 to 28Population: Per protocol population.
Outcome measures
| Measure |
Methoxy Polyethylene Glycol-Epoetin Beta
n=41 Participants
Participants received methoxy polyethylene glycol-epoetin beta once monthly by SC injection, for 28 weeks. The initial dose of methoxy polyethylene glycol-epoetin beta was 120 or 200 or 360 µg if the last weekly dose of previous ESA (darbepoetin alfa) was \<40 µg or 40-80 µg or \>80 µg, respectively. The doses were adjusted according to individual participant's Hb value.
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|---|---|
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Percentage of Participants Maintaining Hb Concentrations Within the Range of 10.0 to 12.0 g/dL Throughout EEP
|
73.17 percentage of participants
Interval 57.06 to 85.78
|
SECONDARY outcome
Timeframe: EEP: Weeks 17 to 28Population: Per protocol population.
Outcome measures
| Measure |
Methoxy Polyethylene Glycol-Epoetin Beta
n=41 Participants
Participants received methoxy polyethylene glycol-epoetin beta once monthly by SC injection, for 28 weeks. The initial dose of methoxy polyethylene glycol-epoetin beta was 120 or 200 or 360 µg if the last weekly dose of previous ESA (darbepoetin alfa) was \<40 µg or 40-80 µg or \>80 µg, respectively. The doses were adjusted according to individual participant's Hb value.
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|---|---|
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Median Time Spent in the Hb Range of 10.0 to 12.0 g/dL During the EEP
|
57.0 days
Interval 0.0 to 86.0
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SECONDARY outcome
Timeframe: DTP: Weeks 1 to 16; EEP: Weeks 17 to 28Population: Per protocol population.
The methoxy polyethylene glycol-epoetin beta dose adjustment (dose increase or decrease) was required: if a single Hb concentration was either greater than or equal to (≥) 13 g/dL or less than or equal to (≤) 9 g/dL; if the difference of 2 consecutive Hb concentrations was ≥2 g/dL; when the values of scheduled Hb assessments on the days of drug administration and on the previous study visit were both out of range of 10.5 to 11.5 g/dL and the difference between the reference value (average Hb concentration calculated on the basis of all Hb assessments taken at Weeks -4, -2, and 0) and the most recent value was \>1 g/dL; and when the values of scheduled Hb assessments on the days of drug administration and on the previous study visit were both out of range of 10 to 12 g/dL. Dose adjustment could be made at any time at the discretion of the clinician if clinically warranted.
Outcome measures
| Measure |
Methoxy Polyethylene Glycol-Epoetin Beta
n=41 Participants
Participants received methoxy polyethylene glycol-epoetin beta once monthly by SC injection, for 28 weeks. The initial dose of methoxy polyethylene glycol-epoetin beta was 120 or 200 or 360 µg if the last weekly dose of previous ESA (darbepoetin alfa) was \<40 µg or 40-80 µg or \>80 µg, respectively. The doses were adjusted according to individual participant's Hb value.
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|---|---|
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Percentage of Participants Requiring Any Dose Adjustment During Dose Titration Period (DTP) and EEP
DTP: Dose Increase Only
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17.1 percentage of participants
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Percentage of Participants Requiring Any Dose Adjustment During Dose Titration Period (DTP) and EEP
DTP: Dose Decrease Only
|
39.0 percentage of participants
|
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Percentage of Participants Requiring Any Dose Adjustment During Dose Titration Period (DTP) and EEP
DTP: Both Dose Increase and Decrease
|
22.0 percentage of participants
|
|
Percentage of Participants Requiring Any Dose Adjustment During Dose Titration Period (DTP) and EEP
EEP: Dose Increase Only
|
31.7 percentage of participants
|
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Percentage of Participants Requiring Any Dose Adjustment During Dose Titration Period (DTP) and EEP
EEP: Dose Decrease Only
|
9.8 percentage of participants
|
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Percentage of Participants Requiring Any Dose Adjustment During Dose Titration Period (DTP) and EEP
EEP: Both Dose Increase and Decrease
|
9.8 percentage of participants
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SECONDARY outcome
Timeframe: Weeks 1 to 28Population: Safety population.
Outcome measures
| Measure |
Methoxy Polyethylene Glycol-Epoetin Beta
n=111 Participants
Participants received methoxy polyethylene glycol-epoetin beta once monthly by SC injection, for 28 weeks. The initial dose of methoxy polyethylene glycol-epoetin beta was 120 or 200 or 360 µg if the last weekly dose of previous ESA (darbepoetin alfa) was \<40 µg or 40-80 µg or \>80 µg, respectively. The doses were adjusted according to individual participant's Hb value.
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|---|---|
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Percentage of Participants Who Required Red Blood Cell Transfusions
|
0.9 percentage of participants
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Adverse Events
Methoxy Polyethylene Glycol-Epoetin Beta
Serious events: 10 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Methoxy Polyethylene Glycol-Epoetin Beta
n=111 participants at risk
Participants received methoxy polyethylene glycol-epoetin beta once monthly by SC injection, for 28 weeks. The initial dose of methoxy polyethylene glycol-epoetin beta was 120 or 200 or 360 µg if the last weekly dose of previous ESA (darbepoetin alfa) was \<40 µg or 40-80 µg or \>80 µg, respectively. The doses were adjusted according to individual participant's Hb value.
|
|---|---|
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Cardiac disorders
Angina pectoris
|
0.90%
1/111 • 36 weeks
Safety population.
|
|
Cardiac disorders
Atrial fibrillation
|
0.90%
1/111 • 36 weeks
Safety population.
|
|
Cardiac disorders
Cardiac failure
|
0.90%
1/111 • 36 weeks
Safety population.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.90%
1/111 • 36 weeks
Safety population.
|
|
Cardiac disorders
Pericardial effusion
|
0.90%
1/111 • 36 weeks
Safety population.
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.90%
1/111 • 36 weeks
Safety population.
|
|
General disorders
Chest pain
|
0.90%
1/111 • 36 weeks
Safety population.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.90%
1/111 • 36 weeks
Safety population.
|
|
Infections and infestations
Pneumonia
|
0.90%
1/111 • 36 weeks
Safety population.
|
|
Investigations
Transaminases increased
|
0.90%
1/111 • 36 weeks
Safety population.
|
|
Renal and urinary disorders
Renal impairment
|
0.90%
1/111 • 36 weeks
Safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.90%
1/111 • 36 weeks
Safety population.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.90%
1/111 • 36 weeks
Safety population.
|
|
Surgical and medical procedures
Hospitalisation
|
0.90%
1/111 • 36 weeks
Safety population.
|
|
Vascular disorders
Extremity necrosis
|
0.90%
1/111 • 36 weeks
Safety population.
|
Other adverse events
| Measure |
Methoxy Polyethylene Glycol-Epoetin Beta
n=111 participants at risk
Participants received methoxy polyethylene glycol-epoetin beta once monthly by SC injection, for 28 weeks. The initial dose of methoxy polyethylene glycol-epoetin beta was 120 or 200 or 360 µg if the last weekly dose of previous ESA (darbepoetin alfa) was \<40 µg or 40-80 µg or \>80 µg, respectively. The doses were adjusted according to individual participant's Hb value.
|
|---|---|
|
Renal and urinary disorders
Renal impairment
|
5.4%
6/111 • 36 weeks
Safety population.
|
|
Vascular disorders
Hypertension
|
9.9%
11/111 • 36 weeks
Safety population.
|
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