Trial Outcomes & Findings for A Study of Subcutaneous C.E.R.A. for the Maintenance of Hemoglobin Levels in Participants With Chronic Renal Anemia Not on Dialysis. (NCT NCT00642304)
NCT ID: NCT00642304
Last Updated: 2018-06-26
Results Overview
The reference Hb value was taken as the time adjusted average of all Hb assessments during the Stability Verification Period (SVP) (Week -4 to Week 0). EEP was from Week 16 to Week 24.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
20 participants
Primary outcome timeframe
EEP (Weeks 16 to 24)
Results posted on
2018-06-26
Participant Flow
Participant milestones
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta
Methoxy polyethylene glycol-epoetin beta was administered subcutaneously (SC) every four weeks up to Week 20. The starting dose was 120, 200 or 300 micrograms (mcg) based on the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding the study start. Further dose was adjusted during the study depending on the hemoglobin (Hb) levels.
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|---|---|
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Overall Study
STARTED
|
20
|
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Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta
Methoxy polyethylene glycol-epoetin beta was administered subcutaneously (SC) every four weeks up to Week 20. The starting dose was 120, 200 or 300 micrograms (mcg) based on the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding the study start. Further dose was adjusted during the study depending on the hemoglobin (Hb) levels.
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|---|---|
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Overall Study
Adverse Event
|
1
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Overall Study
Death
|
1
|
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Overall Study
Blood transfusion
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2
|
|
Overall Study
Erythropoiesis Stimulating Agent Use.
|
1
|
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Overall Study
Transplantation
|
1
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Baseline Characteristics
A Study of Subcutaneous C.E.R.A. for the Maintenance of Hemoglobin Levels in Participants With Chronic Renal Anemia Not on Dialysis.
Baseline characteristics by cohort
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta
n=20 Participants
Methoxy polyethylene glycol-epoetin beta was administered SC every four weeks up to Week 20. The starting dose was 120, 200 or 300 mcg based on the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding the study start. Further dose was adjusted during the study depending on the Hb levels.
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|---|---|
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Age, Continuous
|
64.5 years
STANDARD_DEVIATION 16.83 • n=5 Participants
|
|
Sex: Female, Male
Female
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5 Participants
n=5 Participants
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Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: EEP (Weeks 16 to 24)Population: The Intent- to -treat (ITT) population included all participants who received at least one dose of trial medication at Week 0 and for whom data for at least one follow-up variable (adverse event) was available.
The reference Hb value was taken as the time adjusted average of all Hb assessments during the Stability Verification Period (SVP) (Week -4 to Week 0). EEP was from Week 16 to Week 24.
Outcome measures
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta
n=20 Participants
Methoxy polyethylene glycol-epoetin beta was administered SC every four weeks up to Week 20. The starting dose was 120, 200 or 300 mcg based on the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding the study start. Further dose was adjusted during the study depending on the Hb levels.
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|---|---|
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Percentage of Participants Maintaining Hb Concentration Within +/-1 Gram Per Deciliter (g/dL) of Their Reference Hb and Between 10.5 to 12.5 g/dL Throughout the Efficacy Evaluation Period (EEP)
|
40 Percentage of participants
Interval 19.1 to 64.0
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SECONDARY outcome
Timeframe: SVP (Week -4 to Week 0) and EEP (Week 16 to Week 24)Population: ITT population
The mean change in the time-adjusted average Hb concentration between the two study periods SVP (Baseline) and EEP is presented. The SVP was defined as Week -4 to Week 0. The EEP was defined as Week 16 to Week 24.
Outcome measures
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta
n=20 Participants
Methoxy polyethylene glycol-epoetin beta was administered SC every four weeks up to Week 20. The starting dose was 120, 200 or 300 mcg based on the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding the study start. Further dose was adjusted during the study depending on the Hb levels.
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|---|---|
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Mean Change in Hb Concentration Between SVP and the EEP
|
0.2 g/dL
Standard Deviation 1.15
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SECONDARY outcome
Timeframe: EEP (Weeks 16 to 24)Population: ITT population
The EEP was defined as Week 16 to Week 24.
Outcome measures
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta
n=20 Participants
Methoxy polyethylene glycol-epoetin beta was administered SC every four weeks up to Week 20. The starting dose was 120, 200 or 300 mcg based on the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding the study start. Further dose was adjusted during the study depending on the Hb levels.
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|---|---|
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Percentage of Participants Maintaining Hb Concentration Within Hb Range 10.5 to 12.5 g/dL During the EEP
|
50.0 Percentage of participants
Interval 27.2 to 72.8
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SECONDARY outcome
Timeframe: EEP (Weeks 16 to 24)Population: ITT population
The EEP was defined as Week 16 to Week 24.
Outcome measures
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta
n=20 Participants
Methoxy polyethylene glycol-epoetin beta was administered SC every four weeks up to Week 20. The starting dose was 120, 200 or 300 mcg based on the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding the study start. Further dose was adjusted during the study depending on the Hb levels.
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|---|---|
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Mean Time Spent in Hb Range of 10.5 to 12.5 g/dL During the EEP
|
36.5 Days
Standard Deviation 24.4
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SECONDARY outcome
Timeframe: Baseline up to Week 28Population: ITT population
Outcome measures
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta
n=20 Participants
Methoxy polyethylene glycol-epoetin beta was administered SC every four weeks up to Week 20. The starting dose was 120, 200 or 300 mcg based on the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding the study start. Further dose was adjusted during the study depending on the Hb levels.
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|---|---|
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Percentage of Participants With Blood Transfusion
|
10 Percentage of participants
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SECONDARY outcome
Timeframe: Baseline up to Week 20Population: ITT population
A dose adjustment was defined as a change versus the preceding dose. It included dose increase and dose reduction from the dose given at Baseline.
Outcome measures
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta
n=20 Participants
Methoxy polyethylene glycol-epoetin beta was administered SC every four weeks up to Week 20. The starting dose was 120, 200 or 300 mcg based on the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding the study start. Further dose was adjusted during the study depending on the Hb levels.
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|---|---|
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Percentage of Participants With Dose Adjustment
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60 Percentage of participants
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Adverse Events
Methoxy Polyethylene Glycol-epoetin Beta
Serious events: 6 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta
n=20 participants at risk
Methoxy polyethylene glycol-epoetin beta was administered SC every four weeks up to Week 20. The starting dose was 120, 200 or 300 mcg based on the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding the study start. Further dose was adjusted during the study depending on the Hb levels.
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|---|---|
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Cardiac disorders
Myocardial infarction
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5.0%
1/20 • Baseline up to Week 28
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Gastrointestinal disorders
Diverticular perforation
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5.0%
1/20 • Baseline up to Week 28
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|
Infections and infestations
Pneumonia
|
10.0%
2/20 • Baseline up to Week 28
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Investigations
Blood Potassium increased
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5.0%
1/20 • Baseline up to Week 28
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Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
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5.0%
1/20 • Baseline up to Week 28
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|
Renal and urinary disorders
Renal failure chronic
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5.0%
1/20 • Baseline up to Week 28
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Respiratory, thoracic and mediastinal disorders
Dyspnoea
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5.0%
1/20 • Baseline up to Week 28
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Surgical and medical procedures
Haemodialysis
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5.0%
1/20 • Baseline up to Week 28
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Surgical and medical procedures
Renal transplant
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5.0%
1/20 • Baseline up to Week 28
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Other adverse events
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta
n=20 participants at risk
Methoxy polyethylene glycol-epoetin beta was administered SC every four weeks up to Week 20. The starting dose was 120, 200 or 300 mcg based on the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding the study start. Further dose was adjusted during the study depending on the Hb levels.
|
|---|---|
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Blood and lymphatic system disorders
Anaemia
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5.0%
1/20 • Baseline up to Week 28
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Cardiac disorders
Atrial Fibrillation
|
5.0%
1/20 • Baseline up to Week 28
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Gastrointestinal disorders
Constipation
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5.0%
1/20 • Baseline up to Week 28
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Gastrointestinal disorders
Dyspepsia
|
5.0%
1/20 • Baseline up to Week 28
|
|
Gastrointestinal disorders
Regurgitation
|
5.0%
1/20 • Baseline up to Week 28
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General disorders
Hypothermia
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5.0%
1/20 • Baseline up to Week 28
|
|
Infections and infestations
Bronchitis
|
5.0%
1/20 • Baseline up to Week 28
|
|
Infections and infestations
Cystitis
|
10.0%
2/20 • Baseline up to Week 28
|
|
Infections and infestations
Erysipelas
|
5.0%
1/20 • Baseline up to Week 28
|
|
Infections and infestations
Fungal infection
|
5.0%
1/20 • Baseline up to Week 28
|
|
Infections and infestations
Fungal skin infection
|
5.0%
1/20 • Baseline up to Week 28
|
|
Infections and infestations
Herpes zoster
|
5.0%
1/20 • Baseline up to Week 28
|
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Infections and infestations
Urinary tract infection
|
5.0%
1/20 • Baseline up to Week 28
|
|
Investigations
Blood calcium increased
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5.0%
1/20 • Baseline up to Week 28
|
|
Investigations
Blood phosphorus increased
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10.0%
2/20 • Baseline up to Week 28
|
|
Investigations
Blood potassium increased
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10.0%
2/20 • Baseline up to Week 28
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|
Investigations
Blood pressure increased
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5.0%
1/20 • Baseline up to Week 28
|
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Metabolism and nutrition disorders
Dehydration
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5.0%
1/20 • Baseline up to Week 28
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Metabolism and nutrition disorders
Gout
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5.0%
1/20 • Baseline up to Week 28
|
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Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Keratoacanthoma
|
5.0%
1/20 • Baseline up to Week 28
|
|
Nervous system disorders
Headache
|
5.0%
1/20 • Baseline up to Week 28
|
|
Nervous system disorders
Speech disorder
|
5.0%
1/20 • Baseline up to Week 28
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Nervous system disorders
Transient ischaemic attack
|
5.0%
1/20 • Baseline up to Week 28
|
|
Renal and urinary disorders
Renal failure chronic
|
10.0%
2/20 • Baseline up to Week 28
|
|
Renal and urinary disorders
Urinary bladder haemorrhage
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5.0%
1/20 • Baseline up to Week 28
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
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5.0%
1/20 • Baseline up to Week 28
|
|
Skin and subcutaneous tissue disorders
Dermatosis
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5.0%
1/20 • Baseline up to Week 28
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
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5.0%
1/20 • Baseline up to Week 28
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|
Vascular disorders
Haematoma
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5.0%
1/20 • Baseline up to Week 28
|
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Vascular disorders
Hypertension
|
35.0%
7/20 • Baseline up to Week 28
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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