Trial Outcomes & Findings for Prevalence and Treatment of Anemia in Rehabilitation Patients (NCT NCT00511901)
NCT ID: NCT00511901
Last Updated: 2014-01-31
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
22 participants
Primary outcome timeframe
8 weeks following randomization
Results posted on
2014-01-31
Participant Flow
Subjects recruited at two subacute rehabilitation facilities in Central New Jersey between October 2005 and March 2008
Participant milestones
| Measure |
Placebo & Niferex
Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
|
Epoetin Alpha & Niferex
40,000 IU (initial dose) epoetin alpha subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
|
Overall Study
COMPLETED
|
10
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
Placebo & Niferex
Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
|
Epoetin Alpha & Niferex
40,000 IU (initial dose) epoetin alpha subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
Baseline Characteristics
Prevalence and Treatment of Anemia in Rehabilitation Patients
Baseline characteristics by cohort
| Measure |
Placebo & Niferex
n=11 Participants
Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
|
Epoetin Alpha & Niferex
n=11 Participants
40,000 IU (initial dose) epoetin alpha subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
74.4 years
STANDARD_DEVIATION 8.3 • n=93 Participants
|
75.5 years
STANDARD_DEVIATION 8.4 • n=4 Participants
|
75.0 years
STANDARD_DEVIATION 8.2 • n=27 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White
|
9 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Hemoglobin Level
|
9.8 g/dL
STANDARD_DEVIATION 1.0 • n=93 Participants
|
9.8 g/dL
STANDARD_DEVIATION 0.6 • n=4 Participants
|
9.8 g/dL
STANDARD_DEVIATION 0.8 • n=27 Participants
|
|
Days From Admit to Randomization
|
5.5 Days
STANDARD_DEVIATION 1.5 • n=93 Participants
|
5.3 Days
STANDARD_DEVIATION 1.8 • n=4 Participants
|
5.4 Days
STANDARD_DEVIATION 1.6 • n=27 Participants
|
|
FIM Motor Scale
|
74.2 Scores on a Scale
STANDARD_DEVIATION 8.8 • n=93 Participants
|
68.8 Scores on a Scale
STANDARD_DEVIATION 6.9 • n=4 Participants
|
71.5 Scores on a Scale
STANDARD_DEVIATION 8.2 • n=27 Participants
|
|
FACIT Fatigue Scale
|
31.6 Scores on a Scale
STANDARD_DEVIATION 9.5 • n=93 Participants
|
29.2 Scores on a Scale
STANDARD_DEVIATION 11.6 • n=4 Participants
|
30.4 Scores on a Scale
STANDARD_DEVIATION 10.4 • n=27 Participants
|
|
POMS Depression-Dejection Scale
|
3 Scores on a Scale
n=93 Participants
|
3 Scores on a Scale
n=4 Participants
|
3 Scores on a Scale
n=27 Participants
|
PRIMARY outcome
Timeframe: 8 weeks following randomizationPopulation: Intention to treat; of the subjects not lost to follow-up, 3 subjects in the placebo arm \& 2 subjects in the epoetin alpha arm were not available for 8 week hemoglobin draw
Outcome measures
| Measure |
Placebo & Niferex
n=7 Participants
Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
|
Epoetin Alpha & Niferex
n=6 Participants
40,000 IU (initial dose) epoetin alpha subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
|
|---|---|---|
|
Mean Hemoglobin Concentration at 8 Weeks After Entry Into the Study
|
11.9 g/dL
Standard Deviation 1.2
|
13.6 g/dL
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: 3, 8, and 12 weeks following randomizationPopulation: exact numbers of subjects analyzed at each time point vary based on time of study withdrawal for those who withdrew and availability of subject for those who were under active follow-up
FIM Motor score ranges from 13 to 91 (most independent)
Outcome measures
| Measure |
Placebo & Niferex
n=10 Participants
Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
|
Epoetin Alpha & Niferex
n=9 Participants
40,000 IU (initial dose) epoetin alpha subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
|
|---|---|---|
|
Motor-FIM Score
FIM at 3 weeks (n=9; n=9)
|
76.9 Scores on a Scale
Standard Deviation 4.4
|
77.7 Scores on a Scale
Standard Deviation 5.7
|
|
Motor-FIM Score
FIM at 8 weeks (n=9; n=7)
|
81.7 Scores on a Scale
Standard Deviation 4.2
|
85.0 Scores on a Scale
Standard Deviation 4.4
|
|
Motor-FIM Score
FIM at 12 weeks (n=10; n=8)
|
85.2 Scores on a Scale
Standard Deviation 3.8
|
85.1 Scores on a Scale
Standard Deviation 5.8
|
SECONDARY outcome
Timeframe: 12 weeks following randomizationPopulation: exact numbers of subjects analyzed at each time point vary based on time of study withdrawal for those who withdrew and availability of subject for those who were under active follow-up
Days from randomization to discharge
Outcome measures
| Measure |
Placebo & Niferex
n=10 Participants
Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
|
Epoetin Alpha & Niferex
n=11 Participants
40,000 IU (initial dose) epoetin alpha subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
|
|---|---|---|
|
Length of Stay in Subacute Rehabilitation Facility
|
13.1 Days
Standard Deviation 5.2
|
17.4 Days
Standard Deviation 9.0
|
SECONDARY outcome
Timeframe: 3, 8, and 12 weeks following randomizationPopulation: exact numbers of subjects analyzed at each time point vary based on time of study withdrawal for those who withdrew and availability of subject for those who were under active follow-up
kilograms measured by hand held dynamometer
Outcome measures
| Measure |
Placebo & Niferex
n=10 Participants
Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
|
Epoetin Alpha & Niferex
n=10 Participants
40,000 IU (initial dose) epoetin alpha subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
|
|---|---|---|
|
Grip Strength
Grip Strength at 3 weeks (n=9; n=10)
|
19.0 kg
Standard Deviation 4.0
|
18.4 kg
Standard Deviation 3.1
|
|
Grip Strength
Grip Strength at 8 weeks (n=9; n=7)
|
19.4 kg
Standard Deviation 3.7
|
19.6 kg
Standard Deviation 4.2
|
|
Grip Strength
Grip Strength at 12 weeks (n=10; n=8)
|
17.4 kg
Standard Deviation 3.5
|
19.0 kg
Standard Deviation 3.6
|
SECONDARY outcome
Timeframe: 3, 8, and 12 weeks following randomizationPopulation: exact numbers of subjects analyzed at each time point vary based on time of study withdrawal for those who withdrew and availability of subject for those who were under active follow-up
Measure physical function scored 0 - 12 (better)
Outcome measures
| Measure |
Placebo & Niferex
n=10 Participants
Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
|
Epoetin Alpha & Niferex
n=9 Participants
40,000 IU (initial dose) epoetin alpha subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
|
|---|---|---|
|
Short Physical Performance Battery (SPPB) Score
SPPB at 3 weeks (n=9; n=9)
|
3.4 Scores on a scale
Standard Deviation 1.9
|
3.7 Scores on a scale
Standard Deviation 2.5
|
|
Short Physical Performance Battery (SPPB) Score
SPPB at 8 weeks (n=9; n=7)
|
7.0 Scores on a scale
Standard Deviation 1.9
|
7.4 Scores on a scale
Standard Deviation 2.9
|
|
Short Physical Performance Battery (SPPB) Score
SPPB at 12 weeks (n=10; n=8)
|
8.0 Scores on a scale
Standard Deviation 2.3
|
7.1 Scores on a scale
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: 3, 8, and 12 weeks following randomizationPopulation: exact numbers of subjects analyzed at each time point vary based on time of study withdrawal for those who withdrew and availability of subject for those who were under active follow-up
Fatigue score ranges from 0 to 72. Lower score represents less fatigue
Outcome measures
| Measure |
Placebo & Niferex
n=10 Participants
Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
|
Epoetin Alpha & Niferex
n=9 Participants
40,000 IU (initial dose) epoetin alpha subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
|
|---|---|---|
|
FACIT Measurement System Fatigue Scale
FACIT at 3 weeks (n=8; n=9)
|
38.3 Scores on a Scale
Standard Deviation 6.7
|
35.7 Scores on a Scale
Standard Deviation 10.7
|
|
FACIT Measurement System Fatigue Scale
FACIT at 8 weeks (n=9; n=7)
|
39.8 Scores on a Scale
Standard Deviation 11.2
|
42.3 Scores on a Scale
Standard Deviation 8.3
|
|
FACIT Measurement System Fatigue Scale
FACIT at 12 weeks (n=10; n=8)
|
42.7 Scores on a Scale
Standard Deviation 6.7
|
38.6 Scores on a Scale
Standard Deviation 10.4
|
SECONDARY outcome
Timeframe: 3, 8, and 12 weeks following randomizationPopulation: exact numbers of subjects analyzed at each time point vary based on time of study withdrawal for those who withdrew and availability of subject for those who were under active follow-up
Activity counts as measured by the Actigraph monitor. Higher counts indicate more activity.
Outcome measures
| Measure |
Placebo & Niferex
n=10 Participants
Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
|
Epoetin Alpha & Niferex
n=9 Participants
40,000 IU (initial dose) epoetin alpha subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
|
|---|---|---|
|
Activity Counts
Activity Counts at 8 weeks (n=9; n=6)
|
58.78 Counts
Standard Deviation 32.8
|
70.17 Counts
Standard Deviation 27.3
|
|
Activity Counts
Activity Counts at 3 weeks (n=8; n=9)
|
51.13 Counts
Standard Deviation 27.0
|
41.56 Counts
Standard Deviation 28.1
|
|
Activity Counts
Activity Counts at 12 weeks (n=10; n=8)
|
61.60 Counts
Standard Deviation 27.2
|
77.75 Counts
Standard Deviation 44.6
|
SECONDARY outcome
Timeframe: 3,8,12 weeksPopulation: exact numbers of subjects analyzed at each time point vary based on time of study withdrawal for those who withdrew and availability of subject for those who were under active follow-up
Profile of Mood States (POMS) Depression-Dejection Scale 15 item questionnaire to measure the degree of depressive thoughts. The scale ranges from 0 to 60 (most depressed).
Outcome measures
| Measure |
Placebo & Niferex
n=10 Participants
Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
|
Epoetin Alpha & Niferex
n=10 Participants
40,000 IU (initial dose) epoetin alpha subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
|
|---|---|---|
|
POMS Depression-Dejection Scale
POMS at 3 weeks (n=9; n=10)
|
1 Scores on a Scale
Interval 0.0 to 7.0
|
3.5 Scores on a Scale
Interval 0.0 to 8.0
|
|
POMS Depression-Dejection Scale
POMS at 8 weeks (n=9; n=7)
|
1 Scores on a Scale
Interval 0.0 to 5.0
|
0 Scores on a Scale
Interval 0.0 to 8.0
|
|
POMS Depression-Dejection Scale
POMS at 12 weeks (n=10; n=7)
|
1 Scores on a Scale
Interval 0.0 to 2.0
|
0 Scores on a Scale
Interval 0.0 to 2.0
|
Adverse Events
Placebo & Niferex
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Epoetin Alpha & Niferex
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo & Niferex
n=11 participants at risk
Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
|
Epoetin Alpha & Niferex
n=11 participants at risk
40,000 IU (initial dose) epoetin alpha subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Hip Fracture
|
0.00%
0/11 • 12 weeks
active followup at 3, 8, \& 12 weeks
|
9.1%
1/11 • Number of events 1 • 12 weeks
active followup at 3, 8, \& 12 weeks
|
Other adverse events
Adverse event data not reported
Additional Information
Jeffrey L Carson, MD
University of Medicine and Dentistry of New Jersey
Phone: 732-235-7122
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place