Trial Outcomes & Findings for An Efficacy and Safety Study of Epoetin Alfa for Initiation and Maintenance Treatment of Patients With Anemia Associated With Chronic Kidney Disease (NCT NCT00440557)
NCT ID: NCT00440557
Last Updated: 2014-05-07
Results Overview
The change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included in calculating the average Hb during the last 8 weeks of treatment through Week 22.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
375 participants
Primary outcome timeframe
From baseline through Week 22
Results posted on
2014-05-07
Participant Flow
The study was initiated 29 August 2006 and completed on 21 February 2008. Subjects were screened for eligibility at 64 investigative sites within the U.S. Three hundred seventy-five subjects (intent to treat) were randomly assigned to a treatment group by 52 investigators from 56 sites. Safety population consisted of 373 subjects.
Participant milestones
| Measure |
Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)
Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
|
Epoetin Alfa:Once Weekly (QW)
Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)
|
Epoetin Alfa:Once Every Two Weeks (Q2W)
Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)
|
|---|---|---|---|
|
Overall Study
STARTED
|
123
|
125
|
125
|
|
Overall Study
COMPLETED
|
98
|
96
|
90
|
|
Overall Study
NOT COMPLETED
|
25
|
29
|
35
|
Reasons for withdrawal
| Measure |
Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)
Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
|
Epoetin Alfa:Once Weekly (QW)
Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)
|
Epoetin Alfa:Once Every Two Weeks (Q2W)
Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
10
|
5
|
11
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
6
|
|
Overall Study
Adverse Event
|
3
|
3
|
5
|
|
Overall Study
Death
|
2
|
6
|
3
|
|
Overall Study
Began Dialysis
|
4
|
1
|
4
|
|
Overall Study
Principal Investigator decision
|
0
|
3
|
1
|
|
Overall Study
Patient moved
|
1
|
2
|
1
|
|
Overall Study
Principal Investigator's office closed
|
3
|
6
|
4
|
|
Overall Study
Patient transferred to nursing home
|
0
|
1
|
0
|
|
Overall Study
Patient had surgery
|
1
|
0
|
0
|
Baseline Characteristics
An Efficacy and Safety Study of Epoetin Alfa for Initiation and Maintenance Treatment of Patients With Anemia Associated With Chronic Kidney Disease
Baseline characteristics by cohort
| Measure |
Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)
n=123 Participants
Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
|
Epoetin Alfa:Once Weekly (QW)
n=125 Participants
Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)
|
Epoetin Alfa:Once Every Two Weeks (Q2W)
n=125 Participants
Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)
|
Total
n=373 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
33 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
120 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
90 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
253 Participants
n=4 Participants
|
|
Age, Continuous
|
71.1 years
STANDARD_DEVIATION 13.02 • n=5 Participants
|
68.9 years
STANDARD_DEVIATION 11.86 • n=7 Participants
|
68.9 years
STANDARD_DEVIATION 13.02 • n=5 Participants
|
69.6 years
STANDARD_DEVIATION 12.65 • n=4 Participants
|
|
Sex: Female, Male
Female
|
77 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
242 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
131 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From baseline through Week 22Population: Modified Intent-To-Treat (mITT) population. The mITT population was defined as all participants who were randomized and had at least 1 postrandomization hemoglobin concentration measurement.
The change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included in calculating the average Hb during the last 8 weeks of treatment through Week 22.
Outcome measures
| Measure |
Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)
n=121 Participants
Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
|
Epoetin Alfa:Once Weekly (QW)
n=124 Participants
Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)
|
Epoetin Alfa:Once Every Two Weeks (Q2W)
n=123 Participants
Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)
|
|---|---|---|---|
|
Change in Hb Concentration (g/dL) From Baseline to the Average of the Last 8 Weeks of Treatment Through Week 22
|
1.81 g/dL
Standard Deviation 0.910
|
1.59 g/dL
Standard Deviation 0.997
|
1.27 g/dL
Standard Deviation 0.906
|
SECONDARY outcome
Timeframe: From baseline to Week 9Population: Modified Intent-To-Treat (mITT) population. The mITT population was defined as all participants who were randomized and had at least 1 postrandomization Hb concentration measurement.
The change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. Hb increase is defined as the post-baseline Hb level minus the baseline Hb level.
Outcome measures
| Measure |
Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)
n=121 Participants
Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
|
Epoetin Alfa:Once Weekly (QW)
n=124 Participants
Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)
|
Epoetin Alfa:Once Every Two Weeks (Q2W)
n=124 Participants
Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)
|
|---|---|---|---|
|
Participants With an Increase of ≥1 g/dL in Hb Concentration From Baseline by Week 9
|
116 participants
|
108 participants
|
106 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From baseline to Week 22Population: Safety population. The safety population was defined as all participants who received at least 1 injection of study drug.
The change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. participants who exceed a Hb value of 11.9 g/dL at least once were included in the numerator of the percentage calculation.
Outcome measures
| Measure |
Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)
n=123 Participants
Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
|
Epoetin Alfa:Once Weekly (QW)
n=125 Participants
Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)
|
Epoetin Alfa:Once Every Two Weeks (Q2W)
n=125 Participants
Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)
|
|---|---|---|---|
|
Participants Who Exceeded a Hb Concentration of 11.9 g/dL During First 22 Weeks of Treatment
|
106 participants
|
98 participants
|
89 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From baseline to Week 22Population: Safety population. The safety population was defined as all participants who received at least 1 injection of study drug.
The change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. A maximum Hb observation was identified for each participant during the first 22 weeks of treatment.
Outcome measures
| Measure |
Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)
n=123 Participants
Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
|
Epoetin Alfa:Once Weekly (QW)
n=125 Participants
Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)
|
Epoetin Alfa:Once Every Two Weeks (Q2W)
n=125 Participants
Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)
|
|---|---|---|---|
|
Maximum Hb Concentration (g/dL) During First 22 Weeks of Treatment
|
12.87 g/dL
Standard Deviation 1.176
|
12.61 g/dL
Standard Deviation 1.158 • Interval -0.564 to 0.043
|
12.42 g/dL
Standard Deviation 1.310 • Interval -0.755 to -0.147
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From baseline to Week 22Population: Safety population. The safety population was defined as all subjects who received at least 1 injection of study drug.
Change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. Participants who met or exceeded a Hb Rate of Rise (RR) of 1.0 g/dL/2 weeks at least once were included in the numerator of the percentage calculation.
Outcome measures
| Measure |
Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)
n=123 Participants
Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
|
Epoetin Alfa:Once Weekly (QW)
n=125 Participants
Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)
|
Epoetin Alfa:Once Every Two Weeks (Q2W)
n=125 Participants
Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)
|
|---|---|---|---|
|
Participants Who Met or Exceeded Hb Rate of Rise >=1.0 g/dL/2 Weeks During First 22 Weeks of Treatment
|
119 participants
|
116 participants
|
114 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From baseline to Week 22Population: Safety population. The safety population was defined as all participants who received at least 1 injection of study drug.
Change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. Participants who met or exceeded a Hb Rate of Rise (RR) of 1.5 g/dL/2 weeks at least once were included in the numerator of the percentage calculation.
Outcome measures
| Measure |
Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)
n=123 Participants
Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
|
Epoetin Alfa:Once Weekly (QW)
n=125 Participants
Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)
|
Epoetin Alfa:Once Every Two Weeks (Q2W)
n=125 Participants
Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)
|
|---|---|---|---|
|
Participants Who Met or Exceeded Hb Rate of Rise >=1.5 g/dL/2 Weeks During First 22 Weeks of Treatment
|
87 participants
|
85 participants
|
76 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From baseline to Week 22Population: Safety population. The safety population was defined as all participants who received at least 1 injection of study drug.
Change is calculated as average hemoglobin (Hb) over the last 8 weeks subtracts the baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. Participants who met or exceeded a Hb Rate of Rise (RR) of 2.0 g/dL/2 weeks at least once were included in the numerator of the percentage calculation.
Outcome measures
| Measure |
Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)
n=123 Participants
Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
|
Epoetin Alfa:Once Weekly (QW)
n=125 Participants
Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)
|
Epoetin Alfa:Once Every Two Weeks (Q2W)
n=125 Participants
Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)
|
|---|---|---|---|
|
Particpants Who Met or Exceeded Hb Rate of Rise >=2.0 g/dL/2 Weeks During First 22 Weeks of Treatment
|
47 participants
|
51 participants
|
44 participants
|
POST_HOC outcome
Timeframe: From baseline to Week 22Population: Safety population. The safety population was defined as all participants who received at least 1 injection of study drug.
Change is calculated as mean hemoglobin (Hb) over last 8 wks subtracts baseline Hb. Only Hb measurements up until a participant receives a transfusion or begins dialysis were included. Max Hb RR observation was identified for each participant during the 1st 22 wks of treatment. This was the max RR in hemoglobin over any 2-wk period per participant.
Outcome measures
| Measure |
Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)
n=123 Participants
Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
|
Epoetin Alfa:Once Weekly (QW)
n=125 Participants
Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)
|
Epoetin Alfa:Once Every Two Weeks (Q2W)
n=125 Participants
Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)
|
|---|---|---|---|
|
Maximum (Max) Hb Rate (g/dL/2 Weeks) of Rise During First 22 Weeks of Treatment
|
1.99 g/dL/2 weeks
Standard Deviation 0.839
|
2.02 g/dL/2 weeks
Standard Deviation 1.008 • Interval -0.21 to 0.27
|
1.92 g/dL/2 weeks
Standard Deviation 1.027 • Interval -0.315 to 0.166
|
Adverse Events
Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)
Serious events: 36 serious events
Other events: 93 other events
Deaths: 0 deaths
Epoetin Alfa:Once Weekly (QW)
Serious events: 41 serious events
Other events: 85 other events
Deaths: 0 deaths
Epoetin Alfa:Once Every Two Weeks (Q2W)
Serious events: 42 serious events
Other events: 102 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)
n=123 participants at risk
Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
|
Epoetin Alfa:Once Weekly (QW)
n=125 participants at risk
Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)
|
Epoetin Alfa:Once Every Two Weeks (Q2W)
n=125 participants at risk
Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)
|
|---|---|---|---|
|
Cardiac disorders
Cardiac failure congestive
|
3.3%
4/123 • 44 weeks
|
3.2%
4/125 • 44 weeks
|
4.8%
6/125 • 44 weeks
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/123 • 44 weeks
|
1.6%
2/125 • 44 weeks
|
4.0%
5/125 • 44 weeks
|
|
Cardiac disorders
Acute myocardial infarction
|
0.81%
1/123 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
|
Cardiac disorders
Bradycardia
|
0.81%
1/123 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
|
Cardiac disorders
Coronary artery disease
|
0.81%
1/123 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/123 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/123 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/123 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
|
Cardiac disorders
Subendocardial ischaemia
|
0.00%
0/123 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
|
Infections and infestations
Pneumonia
|
1.6%
2/123 • 44 weeks
|
1.6%
2/125 • 44 weeks
|
1.6%
2/125 • 44 weeks
|
|
Infections and infestations
Urinary tract infection
|
0.81%
1/123 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
1.6%
2/125 • 44 weeks
|
|
Infections and infestations
Cellulitis
|
0.81%
1/123 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
|
Infections and infestations
Abdominal wall abscess
|
0.00%
0/123 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
|
Infections and infestations
Bronchitis
|
0.81%
1/123 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/123 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
|
Infections and infestations
Peritonitis bacterial
|
0.00%
0/123 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
|
Infections and infestations
Sepsis
|
0.00%
0/123 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
|
Infections and infestations
Septic shock
|
0.00%
0/123 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/123 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/123 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
|
Infections and infestations
Subcutaneous abscess
|
0.81%
1/123 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/123 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
|
Infections and infestations
Urosepsis
|
0.81%
1/123 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
4.1%
5/123 • 44 weeks
|
3.2%
4/125 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
0.81%
1/123 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
1.6%
2/125 • 44 weeks
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.81%
1/123 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/123 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/123 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
|
Metabolism and nutrition disorders
Diabetic foot
|
0.00%
0/123 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
|
Metabolism and nutrition disorders
Hyperammonaemia
|
0.81%
1/123 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/123 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/123 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
|
Metabolism and nutrition disorders
Oral intake reduced
|
0.00%
0/123 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
|
Renal and urinary disorders
Renal failure chronic
|
3.3%
4/123 • 44 weeks
|
2.4%
3/125 • 44 weeks
|
4.0%
5/125 • 44 weeks
|
|
Renal and urinary disorders
Renal failure acute
|
1.6%
2/123 • 44 weeks
|
1.6%
2/125 • 44 weeks
|
2.4%
3/125 • 44 weeks
|
|
Renal and urinary disorders
Obstructive uropathy
|
0.81%
1/123 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
|
Renal and urinary disorders
Azotaemia
|
0.00%
0/123 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
|
Renal and urinary disorders
Bladder obstruction
|
0.81%
1/123 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
|
Renal and urinary disorders
Renal impairment
|
0.81%
1/123 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
|
Nervous system disorders
Syncope
|
0.81%
1/123 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
1.6%
2/125 • 44 weeks
|
|
Nervous system disorders
Cerebrovascular accident
|
0.81%
1/123 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
|
Nervous system disorders
Convulsion
|
0.81%
1/123 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
|
Nervous system disorders
Brain stem infarction
|
0.00%
0/123 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/123 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/123 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
|
Nervous system disorders
Dizziness
|
0.00%
0/123 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
|
Nervous system disorders
Encephalomalacia
|
0.00%
0/123 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
|
Nervous system disorders
Encephalopathy
|
0.81%
1/123 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
|
Nervous system disorders
Grand mal convulsion
|
0.81%
1/123 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
|
Nervous system disorders
VIth nerve paralysis
|
0.81%
1/123 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.81%
1/123 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
2.4%
3/125 • 44 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/123 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
1.6%
2/125 • 44 weeks
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/123 • 44 weeks
|
1.6%
2/125 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/123 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
|
Gastrointestinal disorders
Appendicitis perforated
|
0.00%
0/123 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/123 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/123 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/123 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
|
Vascular disorders
Deep vein thrombosis
|
0.81%
1/123 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
1.6%
2/125 • 44 weeks
|
|
Vascular disorders
Hypotension
|
0.81%
1/123 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/123 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
|
Vascular disorders
Arterial stenosis limb
|
0.00%
0/123 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
|
Vascular disorders
Hypertension
|
0.81%
1/123 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/123 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
|
Vascular disorders
Hypovolaemic shock
|
0.81%
1/123 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
|
Vascular disorders
Peripheral embolism
|
0.00%
0/123 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/123 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
|
Vascular disorders
Vascular pseudoaneurysm ruptured
|
0.00%
0/123 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.81%
1/123 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
2.4%
3/125 • 44 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/123 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
2.4%
3/125 • 44 weeks
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.81%
1/123 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
|
Injury, poisoning and procedural complications
Device electrical finding
|
0.00%
0/123 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
|
Injury, poisoning and procedural complications
Failure to capture
|
0.00%
0/123 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
|
Injury, poisoning and procedural complications
Open wound
|
0.00%
0/123 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
|
Injury, poisoning and procedural complications
Therapeutic agent toxicity
|
0.00%
0/123 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/123 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
2.4%
3/125 • 44 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/123 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.81%
1/123 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/123 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.81%
1/123 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory depression
|
0.00%
0/123 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/123 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/123 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/123 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.81%
1/123 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
0.00%
0/123 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastitic
|
0.81%
1/123 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/123 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
|
General disorders
Chest pain
|
0.00%
0/123 • 44 weeks
|
1.6%
2/125 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
|
General disorders
Necrosis
|
0.00%
0/123 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
|
General disorders
Oedema
|
0.00%
0/123 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
|
General disorders
Oedema peripheral
|
0.00%
0/123 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
|
General disorders
Pyrexia
|
0.81%
1/123 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.81%
1/123 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.6%
2/123 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.81%
1/123 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/123 • 44 weeks
|
1.6%
2/125 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/123 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
|
Psychiatric disorders
Mental status changes
|
0.81%
1/123 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
|
Psychiatric disorders
Aggression
|
0.00%
0/123 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/123 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
|
Investigations
Blood creatinine increased
|
0.00%
0/123 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.00%
0/123 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
|
Social circumstances
Walking disability
|
0.81%
1/123 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
|
Cardiac disorders
Aortic valve disease
|
0.00%
0/123 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
|
Cardiac disorders
Atrial fibrillation
|
0.81%
1/123 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/123 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/123 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/123 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.81%
1/123 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
Other adverse events
| Measure |
Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)
n=123 participants at risk
Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
|
Epoetin Alfa:Once Weekly (QW)
n=125 participants at risk
Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)
|
Epoetin Alfa:Once Every Two Weeks (Q2W)
n=125 participants at risk
Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)
|
|---|---|---|---|
|
Infections and infestations
Urinary tract infection
|
7.3%
9/123 • 44 weeks
|
12.0%
15/125 • 44 weeks
|
11.2%
14/125 • 44 weeks
|
|
Infections and infestations
Nasopharyngitis
|
3.3%
4/123 • 44 weeks
|
5.6%
7/125 • 44 weeks
|
5.6%
7/125 • 44 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
10.6%
13/123 • 44 weeks
|
10.4%
13/125 • 44 weeks
|
8.0%
10/125 • 44 weeks
|
|
Gastrointestinal disorders
Nausea
|
10.6%
13/123 • 44 weeks
|
7.2%
9/125 • 44 weeks
|
7.2%
9/125 • 44 weeks
|
|
Gastrointestinal disorders
Vomiting
|
6.5%
8/123 • 44 weeks
|
6.4%
8/125 • 44 weeks
|
8.0%
10/125 • 44 weeks
|
|
Gastrointestinal disorders
Constipation
|
6.5%
8/123 • 44 weeks
|
2.4%
3/125 • 44 weeks
|
11.2%
14/125 • 44 weeks
|
|
General disorders
Fatigue
|
10.6%
13/123 • 44 weeks
|
7.2%
9/125 • 44 weeks
|
9.6%
12/125 • 44 weeks
|
|
General disorders
Oedema
|
10.6%
13/123 • 44 weeks
|
8.8%
11/125 • 44 weeks
|
8.0%
10/125 • 44 weeks
|
|
General disorders
Oedema peripheral
|
12.2%
15/123 • 44 weeks
|
5.6%
7/125 • 44 weeks
|
9.6%
12/125 • 44 weeks
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
12.2%
15/123 • 44 weeks
|
8.0%
10/125 • 44 weeks
|
11.2%
14/125 • 44 weeks
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
4.9%
6/123 • 44 weeks
|
3.2%
4/125 • 44 weeks
|
3.2%
4/125 • 44 weeks
|
|
Nervous system disorders
Dizziness
|
9.8%
12/123 • 44 weeks
|
5.6%
7/125 • 44 weeks
|
12.8%
16/125 • 44 weeks
|
|
Nervous system disorders
Headache
|
12.2%
15/123 • 44 weeks
|
7.2%
9/125 • 44 weeks
|
2.4%
3/125 • 44 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.6%
13/123 • 44 weeks
|
0.80%
1/125 • 44 weeks
|
4.8%
6/125 • 44 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.3%
9/123 • 44 weeks
|
6.4%
8/125 • 44 weeks
|
1.6%
2/125 • 44 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.9%
6/123 • 44 weeks
|
4.8%
6/125 • 44 weeks
|
4.8%
6/125 • 44 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.6%
2/123 • 44 weeks
|
1.6%
2/125 • 44 weeks
|
5.6%
7/125 • 44 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.1%
5/123 • 44 weeks
|
4.0%
5/125 • 44 weeks
|
8.8%
11/125 • 44 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.7%
7/123 • 44 weeks
|
5.6%
7/125 • 44 weeks
|
4.0%
5/125 • 44 weeks
|
|
Vascular disorders
Hypertension
|
12.2%
15/123 • 44 weeks
|
14.4%
18/125 • 44 weeks
|
8.0%
10/125 • 44 weeks
|
|
Vascular disorders
Hypotension
|
4.9%
6/123 • 44 weeks
|
4.0%
5/125 • 44 weeks
|
8.0%
10/125 • 44 weeks
|
|
Psychiatric disorders
Insomnia
|
2.4%
3/123 • 44 weeks
|
6.4%
8/125 • 44 weeks
|
3.2%
4/125 • 44 weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
2.4%
3/123 • 44 weeks
|
0.00%
0/125 • 44 weeks
|
5.6%
7/125 • 44 weeks
|
Additional Information
Sr Director of Clinical Research
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Phone: 908-927-2116
Results disclosure agreements
- Principal investigator is a sponsor employee Disclosure restrictions on the PI are pre- review of publications prior to public release. Sponsor can embargo trial result publication for up to 120 days. The PI may not publish the sponsor's confidential information without consent. In multi-center trials, individual PI's may publish results only if the study group has not published results 12 months after study completion, abandonment, or termination. The sponsor cannot require changes to the scientific content and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER