Trial Outcomes & Findings for A Study of Subcutaneous Mircera for the Treatment of Anemia in Pre-Dialysis Participants With Chronic Kidney Disease. (NCT NCT00462384)
NCT ID: NCT00462384
Last Updated: 2016-04-01
Results Overview
The baseline hemoglobin was defined as the mean of the assessments recorded during the screening period (Weeks -2 and 0). EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period. EEP hemoglobin was defined as the mean of the assessments recorded during the EEP.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
39 participants
Primary outcome timeframe
Baseline (Week -2 to 0) and EEP (Weeks 29 to 36)
Results posted on
2016-04-01
Participant Flow
Participant milestones
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta
Methoxy polyethylene glycol-epoetin beta was administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose was 1.2 micrograms per kilogram (mcg/kg) body weight. Thereafter, throughout the duration of study the dose adjustments were performed depending on the hemoglobin value.
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|---|---|
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Overall Study
STARTED
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39
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Overall Study
COMPLETED
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30
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Overall Study
NOT COMPLETED
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9
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Reasons for withdrawal
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta
Methoxy polyethylene glycol-epoetin beta was administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose was 1.2 micrograms per kilogram (mcg/kg) body weight. Thereafter, throughout the duration of study the dose adjustments were performed depending on the hemoglobin value.
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|---|---|
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Overall Study
Adverse Event
|
2
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Overall Study
Death
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2
|
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Overall Study
Withdrawal by Subject
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1
|
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Overall Study
Other
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4
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Baseline Characteristics
A Study of Subcutaneous Mircera for the Treatment of Anemia in Pre-Dialysis Participants With Chronic Kidney Disease.
Baseline characteristics by cohort
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta
n=39 Participants
Methoxy polyethylene glycol-epoetin beta was administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose was 1.2 mcg/kg body weight. Thereafter, throughout the duration of study the dose adjustments were performed depending on the hemoglobin value.
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|---|---|
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Age, Continuous
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61.6 years
STANDARD_DEVIATION 18.25 • n=5 Participants
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Sex: Female, Male
Female
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28 Participants
n=5 Participants
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Sex: Female, Male
Male
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11 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Baseline (Week -2 to 0) and EEP (Weeks 29 to 36)Population: Intent to treat (ITT) population: included all participants who received at least one dose of methoxy polyethylene glycol-epoetin beta and for whom data for at least one study variable was available.
The baseline hemoglobin was defined as the mean of the assessments recorded during the screening period (Weeks -2 and 0). EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period. EEP hemoglobin was defined as the mean of the assessments recorded during the EEP.
Outcome measures
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta
n=39 Participants
Methoxy polyethylene glycol-epoetin beta was administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose was 1.2 mcg/kg body weight. Thereafter, throughout the duration of study the dose adjustments were performed depending on the hemoglobin value.
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|---|---|
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Mean Change in Hemoglobin Concentration Between Baseline and the Efficacy Evaluation Period (EEP)
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1.32 grams per deciliter (g/dL)
Standard Deviation 0.88
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SECONDARY outcome
Timeframe: Baseline to Week 40Population: ITT population
Time to achievement of response was the time (number of days) required to achieve hemoglobin levels within the range of 11.0 to 13.0 g/dL.
Outcome measures
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta
n=39 Participants
Methoxy polyethylene glycol-epoetin beta was administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose was 1.2 mcg/kg body weight. Thereafter, throughout the duration of study the dose adjustments were performed depending on the hemoglobin value.
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|---|---|
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Time to Achievement of Response
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24.6 days
Standard Deviation 20.53
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SECONDARY outcome
Timeframe: EEP (Weeks 29 to 36)Population: ITT population
EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period. The percentage of participants whose hemoglobin concentrations remained within the range of 11.0-13.0 g/dL at all assessments throughout the EEP is presented.
Outcome measures
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta
n=39 Participants
Methoxy polyethylene glycol-epoetin beta was administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose was 1.2 mcg/kg body weight. Thereafter, throughout the duration of study the dose adjustments were performed depending on the hemoglobin value.
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|---|---|
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Percentage of Participants Maintaining Hemoglobin Concentration Within Hemoglobin Range 11.0 to 13.0 g/dL Throughout the EEP
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53.9 percentage of participants
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SECONDARY outcome
Timeframe: EEP (Weeks 29 to 36)Population: ITT population
EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period. The percentage of participants whose average hemoglobin concentration was within the range of 11.0-13.0 g/dL during the EEP is presented.
Outcome measures
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta
n=39 Participants
Methoxy polyethylene glycol-epoetin beta was administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose was 1.2 mcg/kg body weight. Thereafter, throughout the duration of study the dose adjustments were performed depending on the hemoglobin value.
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|---|---|
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Percentage of Participants Maintaining Average Hemoglobin Concentration Within Hemoglobin Range 11.0 to 13.0 g/dL During the EEP
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66.7 percentage of participants
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SECONDARY outcome
Timeframe: EEP (Weeks 29 to 36)Population: ITT population
EEP was the first 8 weeks (Weeks 29 to 36) following the 28 weeks dose titration period.
Outcome measures
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta
n=39 Participants
Methoxy polyethylene glycol-epoetin beta was administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose was 1.2 mcg/kg body weight. Thereafter, throughout the duration of study the dose adjustments were performed depending on the hemoglobin value.
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|---|---|
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Time Spent in Hemoglobin Range of 11.0 to 13.0 g/dL During the EEP
|
42.5 days
Standard Deviation 13.96
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Adverse Events
Methoxy Polyethylene Glycol-epoetin Beta
Serious events: 11 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta
n=39 participants at risk
Methoxy polyethylene glycol-epoetin beta was administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose was 1.2 mcg/kg body weight. Thereafter, throughout the duration of study the dose adjustments were performed depending on the hemoglobin value.
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|---|---|
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Cardiac disorders
Angina pectoris
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2.6%
1/39 • Baseline up to Week 40
Safety population
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Cardiac disorders
Arteriosclerosis coronary artery
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2.6%
1/39 • Baseline up to Week 40
Safety population
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Cardiac disorders
Atrial fibrillation
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2.6%
1/39 • Baseline up to Week 40
Safety population
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Infections and infestations
Bronchitis
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2.6%
1/39 • Baseline up to Week 40
Safety population
|
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Infections and infestations
Otitis media chronic
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2.6%
1/39 • Baseline up to Week 40
Safety population
|
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Infections and infestations
Pneumonia
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2.6%
1/39 • Baseline up to Week 40
Safety population
|
|
Infections and infestations
Postoperative wound infection
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2.6%
1/39 • Baseline up to Week 40
Safety population
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Metabolism and nutrition disorders
Iron deficiency
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2.6%
1/39 • Baseline up to Week 40
Safety population
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Musculoskeletal and connective tissue disorders
Back pain
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2.6%
1/39 • Baseline up to Week 40
Safety population
|
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Pregnancy, puerperium and perinatal conditions
Intra-uterine death
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2.6%
1/39 • Baseline up to Week 40
Safety population
|
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Renal and urinary disorders
Azotaemia
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2.6%
1/39 • Baseline up to Week 40
Safety population
|
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Reproductive system and breast disorders
Postmenopausal haemorrhage
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2.6%
1/39 • Baseline up to Week 40
Safety population
|
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Skin and subcutaneous tissue disorders
Skin ulcer
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2.6%
1/39 • Baseline up to Week 40
Safety population
|
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Surgical and medical procedures
Foot amputation
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2.6%
1/39 • Baseline up to Week 40
Safety population
|
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Vascular disorders
Peripheral ischaemia
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2.6%
1/39 • Baseline up to Week 40
Safety population
|
Other adverse events
| Measure |
Methoxy Polyethylene Glycol-epoetin Beta
n=39 participants at risk
Methoxy polyethylene glycol-epoetin beta was administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose was 1.2 mcg/kg body weight. Thereafter, throughout the duration of study the dose adjustments were performed depending on the hemoglobin value.
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|---|---|
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Infections and infestations
Urinary tract infection
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10.3%
4/39 • Baseline up to Week 40
Safety population
|
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Psychiatric disorders
Insomnia
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5.1%
2/39 • Baseline up to Week 40
Safety population
|
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Renal and urinary disorders
Urine odour abnormal
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5.1%
2/39 • Baseline up to Week 40
Safety population
|
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Vascular disorders
Hypertension
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12.8%
5/39 • Baseline up to Week 40
Safety population
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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