Trial Outcomes & Findings for PROCRIT Extended Dosing For Maintenance of Hemoglobin in Pre-Dialysis CKD Patients (NCT NCT00440466)
NCT ID: NCT00440466
Last Updated: 2014-04-21
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
430 participants
Primary outcome timeframe
from baseline (Week 1) to the last 12 weeks of treatment
Results posted on
2014-04-21
Participant Flow
Participant milestones
| Measure |
Epoetin Alfa QW
Continue pre-study once weekly dose of epoetin alfa for 36 weeks
|
Epoetin Alfa Q2W
Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
|
Epoetin Alfa Q4W
Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
|
|---|---|---|---|
|
Overall Study
STARTED
|
108
|
107
|
215
|
|
Overall Study
COMPLETED
|
95
|
92
|
174
|
|
Overall Study
NOT COMPLETED
|
13
|
15
|
41
|
Reasons for withdrawal
| Measure |
Epoetin Alfa QW
Continue pre-study once weekly dose of epoetin alfa for 36 weeks
|
Epoetin Alfa Q2W
Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
|
Epoetin Alfa Q4W
Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
|
|---|---|---|---|
|
Overall Study
Death
|
3
|
2
|
9
|
|
Overall Study
Adverse Event
|
3
|
4
|
11
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
2
|
|
Overall Study
Physician Decision
|
2
|
0
|
1
|
|
Overall Study
Protocol Violation
|
2
|
0
|
4
|
|
Overall Study
Withdrawal by Subject
|
2
|
5
|
9
|
|
Overall Study
Began Dialysis
|
0
|
0
|
1
|
|
Overall Study
Met Hemoglobin Withdrawal Criteria
|
0
|
4
|
4
|
Baseline Characteristics
PROCRIT Extended Dosing For Maintenance of Hemoglobin in Pre-Dialysis CKD Patients
Baseline characteristics by cohort
| Measure |
Epoetin Alfa QW
n=108 Participants
Continue pre-study once weekly dose of epoetin alfa for 36 weeks
|
Epoetin Alfa Q2W
n=107 Participants
Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
|
Epoetin Alfa Q4W
n=215 Participants
Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
|
Total
n=430 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
|
26 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
116 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
75 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
158 Participants
n=5 Participants
|
314 Participants
n=4 Participants
|
|
Age, Continuous
|
70.3 years
STANDARD_DEVIATION 13.04 • n=5 Participants
|
71.7 years
STANDARD_DEVIATION 10.63 • n=7 Participants
|
71.1 years
STANDARD_DEVIATION 12.48 • n=5 Participants
|
71 years
STANDARD_DEVIATION 12.18 • n=4 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
126 Participants
n=5 Participants
|
267 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
163 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: from baseline (Week 1) to the last 12 weeks of treatmentPopulation: Modified Intent-To-Treat (mITT) population defined as all participants who were randomly assigned to treatment with epoetin alfa and had at least 1 post-randomization hemoglobin assessment.
Outcome measures
| Measure |
Epoetin Alfa QW
n=107 Participants
Continue pre-study once weekly dose of epoetin alfa for 36 weeks
|
Epoetin Alfa Q2W
n=105 Participants
Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
|
Epoetin Alfa Q4W
n=215 Participants
Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
|
|---|---|---|---|
|
Change in Hemoglobin Concentration in Grams Per Deciliter (g/dL) From Baseline to the Average of the Last 12 Weeks of Treatment
|
-0.02 g/dL
Standard Deviation 0.728
|
-0.10 g/dL
Standard Deviation 0.774
|
-0.19 g/dL
Standard Deviation 0.738
|
SECONDARY outcome
Timeframe: Weeks 13-37Population: Modified Intent-To-Treat (mITT) population defined as all participants who were randomly assigned to treatment with epoetin alfa and had at least 1 post-randomization hemoglobin assessment.
Outcome measures
| Measure |
Epoetin Alfa QW
n=97 Participants
Continue pre-study once weekly dose of epoetin alfa for 36 weeks
|
Epoetin Alfa Q2W
n=100 Participants
Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
|
Epoetin Alfa Q4W
n=200 Participants
Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
|
|---|---|---|---|
|
Proportion of Weeks Per Patient With Hemoglobin Concentration Between 10.0 and 11.9 Grams Per Deciliter (g/dL)
|
0.87 Proportion
Interval 0.3 to 1.0
|
0.88 Proportion
Interval 0.0 to 1.0
|
0.83 Proportion
Interval 0.0 to 1.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 36 weeks of treatmentPopulation: Safety population defined as all participants who received at least 1 injection of study drug
Outcome measures
| Measure |
Epoetin Alfa QW
n=107 Participants
Continue pre-study once weekly dose of epoetin alfa for 36 weeks
|
Epoetin Alfa Q2W
n=105 Participants
Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
|
Epoetin Alfa Q4W
n=215 Participants
Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
|
|---|---|---|---|
|
Participants Who Exceeded a Hemoglobin Concentration of 11.9 Grams Per Deciliter (g/dL)
|
79 Participants
|
89 Participants
|
161 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 36 weeks of treatmentPopulation: Safety population defined as all participants who received at least 1 injection of study drug
Outcome measures
| Measure |
Epoetin Alfa QW
n=107 Participants
Continue pre-study once weekly dose of epoetin alfa for 36 weeks
|
Epoetin Alfa Q2W
n=105 Participants
Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
|
Epoetin Alfa Q4W
n=215 Participants
Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
|
|---|---|---|---|
|
Maximum Hemoglobin Concentration in Grams Per Deciliter (g/dL)
|
12.35 g/dL
Standard Deviation 0.828
|
12.48 g/dL
Standard Deviation 0.760
|
12.46 g/dL
Standard Deviation 0.988
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 36 weeks of treatmentPopulation: Safety population defined as all participants who received at least 1 injection of study drug
Outcome measures
| Measure |
Epoetin Alfa QW
n=107 Participants
Continue pre-study once weekly dose of epoetin alfa for 36 weeks
|
Epoetin Alfa Q2W
n=105 Participants
Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
|
Epoetin Alfa Q4W
n=215 Participants
Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
|
|---|---|---|---|
|
Participants Who Met or Exceeded 1.0 Grams Per Deciliter Per 2 Weeks (g/dL/2 Weeks) Hemoglobin Rates of Rise
|
84 Particpants
|
91 Particpants
|
191 Particpants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 36 weeks of treatmentOutcome measures
| Measure |
Epoetin Alfa QW
n=107 Participants
Continue pre-study once weekly dose of epoetin alfa for 36 weeks
|
Epoetin Alfa Q2W
n=105 Participants
Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
|
Epoetin Alfa Q4W
n=215 Participants
Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
|
|---|---|---|---|
|
Participants Who Met or Exceeded 1.5 Grams Per Deciliter Per 2 Weeks (g/dL/2 Weeks) Hemoglobin Rates of Rise
|
52 Participants
|
57 Participants
|
124 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 36 weeks of treatmentPopulation: Safety population defined as all participants who received at least 1 injection of study drug
Outcome measures
| Measure |
Epoetin Alfa QW
n=107 Participants
Continue pre-study once weekly dose of epoetin alfa for 36 weeks
|
Epoetin Alfa Q2W
n=105 Participants
Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
|
Epoetin Alfa Q4W
n=215 Participants
Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
|
|---|---|---|---|
|
Participants Who Met or Exceeded 2.0 Grams Per Deciliter Per 2 Weeks (g/dL/2 Weeks) Hemoglobin Rates of Rise
|
37 Participants
|
33 Participants
|
68 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 36 weeks of treatmentPopulation: Safety population defined as all participants who received at least 1 injection of study drug
Outcome measures
| Measure |
Epoetin Alfa QW
n=107 Participants
Continue pre-study once weekly dose of epoetin alfa for 36 weeks
|
Epoetin Alfa Q2W
n=105 Participants
Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
|
Epoetin Alfa Q4W
n=215 Participants
Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
|
|---|---|---|---|
|
Maximum Hemoglobin Rate of Rise in Grams Per Deciliter (g/dL/2 Weeks)
|
1.77 g/dL/2 weeks
Standard Deviation 1.068
|
1.69 g/dL/2 weeks
Standard Deviation 0.790
|
1.81 g/dL/2 weeks
Standard Deviation 1.173
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 36 weeks of treatmentOutcome measures
| Measure |
Epoetin Alfa QW
n=108 Participants
Continue pre-study once weekly dose of epoetin alfa for 36 weeks
|
Epoetin Alfa Q2W
n=107 Participants
Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
|
Epoetin Alfa Q4W
n=215 Participants
Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
|
|---|---|---|---|
|
Number of Participants Who Died
|
4 Participants
|
3 Participants
|
9 Participants
|
Adverse Events
Epoetin Alfa QW
Serious events: 24 serious events
Other events: 59 other events
Deaths: 0 deaths
Epoetin Alfa Q2W
Serious events: 28 serious events
Other events: 59 other events
Deaths: 0 deaths
Epoetin Alfa Q4W
Serious events: 56 serious events
Other events: 116 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Epoetin Alfa QW
n=108 participants at risk
Continue pre-study once weekly dose of epoetin alfa for 36 weeks
|
Epoetin Alfa Q2W
n=107 participants at risk
Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
|
Epoetin Alfa Q4W
n=215 participants at risk
Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.9%
2/108
|
3.7%
4/107
|
0.47%
1/215
|
|
Blood and lymphatic system disorders
Hypercoagulation
|
0.93%
1/108
|
0.00%
0/107
|
0.00%
0/215
|
|
Blood and lymphatic system disorders
Splenic cyst
|
0.00%
0/108
|
0.00%
0/107
|
0.47%
1/215
|
|
Cardiac disorders
Cardiac failure congestive
|
4.6%
5/108
|
7.5%
8/107
|
1.9%
4/215
|
|
Cardiac disorders
Myocardial infarction
|
1.9%
2/108
|
0.00%
0/107
|
0.93%
2/215
|
|
Cardiac disorders
Acute myocardial infarction
|
0.93%
1/108
|
1.9%
2/107
|
0.00%
0/215
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/108
|
0.93%
1/107
|
0.93%
2/215
|
|
Cardiac disorders
Cardiac failure
|
0.93%
1/108
|
0.00%
0/107
|
0.47%
1/215
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/108
|
0.93%
1/107
|
0.47%
1/215
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/108
|
0.93%
1/107
|
0.47%
1/215
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/108
|
0.00%
0/107
|
0.93%
2/215
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/108
|
0.00%
0/107
|
0.47%
1/215
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/108
|
0.93%
1/107
|
0.00%
0/215
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/108
|
0.00%
0/107
|
0.47%
1/215
|
|
Cardiac disorders
Cardiomyopathy
|
0.93%
1/108
|
0.00%
0/107
|
0.00%
0/215
|
|
Cardiac disorders
Coronary artery occlusion
|
0.93%
1/108
|
0.00%
0/107
|
0.00%
0/215
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/108
|
0.00%
0/107
|
0.47%
1/215
|
|
Cardiac disorders
Sick sinus syndrome
|
0.00%
0/108
|
0.93%
1/107
|
0.00%
0/215
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.93%
1/108
|
0.00%
0/107
|
0.00%
0/215
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/108
|
0.00%
0/107
|
0.47%
1/215
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/108
|
0.93%
1/107
|
1.4%
3/215
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/108
|
0.93%
1/107
|
0.47%
1/215
|
|
Gastrointestinal disorders
Diarrhoea
|
0.93%
1/108
|
0.00%
0/107
|
0.47%
1/215
|
|
Gastrointestinal disorders
Pancreatitis
|
0.93%
1/108
|
0.00%
0/107
|
0.47%
1/215
|
|
Gastrointestinal disorders
Alcoholic pancreatitis
|
0.00%
0/108
|
0.00%
0/107
|
0.47%
1/215
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/108
|
0.00%
0/107
|
0.47%
1/215
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/108
|
0.00%
0/107
|
0.47%
1/215
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.00%
0/108
|
0.00%
0/107
|
0.47%
1/215
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/108
|
0.00%
0/107
|
0.47%
1/215
|
|
Gastrointestinal disorders
Gastric antral vascular ectasia
|
0.00%
0/108
|
0.93%
1/107
|
0.00%
0/215
|
|
Gastrointestinal disorders
Gastric mucosal lesion
|
0.00%
0/108
|
0.93%
1/107
|
0.00%
0/215
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/108
|
0.00%
0/107
|
0.47%
1/215
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/108
|
0.93%
1/107
|
0.00%
0/215
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/108
|
0.93%
1/107
|
0.00%
0/215
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/108
|
0.00%
0/107
|
0.47%
1/215
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.93%
1/108
|
0.00%
0/107
|
0.00%
0/215
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/108
|
0.00%
0/107
|
0.47%
1/215
|
|
Gastrointestinal disorders
Oesophageal ulcer haemorrhage
|
0.00%
0/108
|
0.93%
1/107
|
0.00%
0/215
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/108
|
0.93%
1/107
|
0.00%
0/215
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/108
|
0.00%
0/107
|
0.47%
1/215
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/108
|
0.00%
0/107
|
0.47%
1/215
|
|
General disorders
Chest pain
|
3.7%
4/108
|
1.9%
2/107
|
1.4%
3/215
|
|
General disorders
Asthenia
|
0.93%
1/108
|
0.00%
0/107
|
0.47%
1/215
|
|
General disorders
Sudden cardiac death
|
1.9%
2/108
|
0.00%
0/107
|
0.00%
0/215
|
|
General disorders
Chest discomfort
|
0.00%
0/108
|
0.00%
0/107
|
0.47%
1/215
|
|
General disorders
Pyrexia
|
0.93%
1/108
|
0.00%
0/107
|
0.00%
0/215
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/108
|
0.93%
1/107
|
0.47%
1/215
|
|
Hepatobiliary disorders
Gallbladder disorder
|
0.00%
0/108
|
0.93%
1/107
|
0.47%
1/215
|
|
Hepatobiliary disorders
Liver disorder
|
0.93%
1/108
|
0.00%
0/107
|
0.00%
0/215
|
|
Infections and infestations
Cellulitis
|
0.00%
0/108
|
0.93%
1/107
|
1.4%
3/215
|
|
Infections and infestations
Pneumonia
|
0.00%
0/108
|
0.93%
1/107
|
0.93%
2/215
|
|
Infections and infestations
Bronchitis
|
0.00%
0/108
|
0.93%
1/107
|
0.47%
1/215
|
|
Infections and infestations
Urinary tract infection
|
1.9%
2/108
|
0.00%
0/107
|
0.00%
0/215
|
|
Infections and infestations
Viral infection
|
1.9%
2/108
|
0.00%
0/107
|
0.00%
0/215
|
|
Infections and infestations
Diverticulitis
|
0.93%
1/108
|
0.00%
0/107
|
0.00%
0/215
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/108
|
0.00%
0/107
|
0.47%
1/215
|
|
Infections and infestations
Intervertebral discitis
|
0.00%
0/108
|
0.00%
0/107
|
0.47%
1/215
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/108
|
0.93%
1/107
|
0.00%
0/215
|
|
Infections and infestations
Paronychia
|
0.00%
0/108
|
0.00%
0/107
|
0.47%
1/215
|
|
Infections and infestations
Pharyngeal abscess
|
0.00%
0/108
|
0.93%
1/107
|
0.00%
0/215
|
|
Infections and infestations
Sepsis syndrome
|
0.00%
0/108
|
0.00%
0/107
|
0.47%
1/215
|
|
Infections and infestations
Urosepsis
|
0.00%
0/108
|
0.93%
1/107
|
0.00%
0/215
|
|
Injury, poisoning and procedural complications
Fall
|
0.93%
1/108
|
0.00%
0/107
|
0.47%
1/215
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/108
|
0.00%
0/107
|
0.47%
1/215
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/108
|
0.00%
0/107
|
0.47%
1/215
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/108
|
0.00%
0/107
|
0.47%
1/215
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/108
|
0.00%
0/107
|
0.47%
1/215
|
|
Injury, poisoning and procedural complications
Post procedural myocardial infarction
|
0.00%
0/108
|
0.00%
0/107
|
0.47%
1/215
|
|
Investigations
International normalised ratio increased
|
0.00%
0/108
|
0.00%
0/107
|
0.93%
2/215
|
|
Investigations
Blood creatinine increased
|
0.00%
0/108
|
0.93%
1/107
|
0.00%
0/215
|
|
Metabolism and nutrition disorders
Dehydration
|
2.8%
3/108
|
1.9%
2/107
|
0.00%
0/215
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.93%
1/108
|
0.93%
1/107
|
1.4%
3/215
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/108
|
0.00%
0/107
|
0.47%
1/215
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/108
|
0.00%
0/107
|
0.47%
1/215
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/108
|
0.93%
1/107
|
0.00%
0/215
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.93%
1/108
|
0.00%
0/107
|
0.00%
0/215
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.93%
1/108
|
0.00%
0/107
|
0.47%
1/215
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/108
|
0.00%
0/107
|
0.47%
1/215
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/108
|
0.00%
0/107
|
0.47%
1/215
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/108
|
0.93%
1/107
|
0.00%
0/215
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/108
|
0.00%
0/107
|
0.47%
1/215
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.93%
1/108
|
0.00%
0/107
|
0.00%
0/215
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/108
|
0.00%
0/107
|
0.47%
1/215
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer in situ
|
0.00%
0/108
|
0.00%
0/107
|
0.47%
1/215
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic carcinoid tumour
|
0.00%
0/108
|
0.93%
1/107
|
0.00%
0/215
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/108
|
0.93%
1/107
|
0.00%
0/215
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.00%
0/108
|
0.00%
0/107
|
0.47%
1/215
|
|
Nervous system disorders
Transient ischaemic attack
|
0.93%
1/108
|
0.93%
1/107
|
1.4%
3/215
|
|
Nervous system disorders
Syncope
|
0.93%
1/108
|
0.00%
0/107
|
0.93%
2/215
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/108
|
0.00%
0/107
|
0.93%
2/215
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/108
|
0.00%
0/107
|
0.47%
1/215
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/108
|
0.93%
1/107
|
0.00%
0/215
|
|
Nervous system disorders
Cervical cord compression
|
0.00%
0/108
|
0.93%
1/107
|
0.00%
0/215
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/108
|
0.00%
0/107
|
0.47%
1/215
|
|
Nervous system disorders
Migraine
|
0.93%
1/108
|
0.00%
0/107
|
0.00%
0/215
|
|
Nervous system disorders
Presyncope
|
0.93%
1/108
|
0.00%
0/107
|
0.00%
0/215
|
|
Nervous system disorders
Vascular dementia
|
0.00%
0/108
|
0.00%
0/107
|
0.47%
1/215
|
|
Psychiatric disorders
Delirium
|
0.00%
0/108
|
0.00%
0/107
|
0.47%
1/215
|
|
Renal and urinary disorders
Renal failure acute
|
4.6%
5/108
|
4.7%
5/107
|
0.47%
1/215
|
|
Renal and urinary disorders
Renal failure chronic
|
0.00%
0/108
|
1.9%
2/107
|
0.47%
1/215
|
|
Renal and urinary disorders
Renal failure
|
0.93%
1/108
|
0.00%
0/107
|
0.47%
1/215
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/108
|
0.00%
0/107
|
0.93%
2/215
|
|
Renal and urinary disorders
Azotaemia
|
0.00%
0/108
|
0.00%
0/107
|
0.47%
1/215
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/108
|
0.00%
0/107
|
0.47%
1/215
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.93%
1/108
|
0.00%
0/107
|
0.00%
0/215
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/108
|
0.00%
0/107
|
0.47%
1/215
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.93%
1/108
|
1.9%
2/107
|
0.47%
1/215
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/108
|
0.93%
1/107
|
0.93%
2/215
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.93%
1/108
|
0.00%
0/107
|
0.00%
0/215
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/108
|
0.00%
0/107
|
0.47%
1/215
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/108
|
0.00%
0/107
|
0.47%
1/215
|
|
Skin and subcutaneous tissue disorders
Increased tendency to bruise
|
0.00%
0/108
|
0.00%
0/107
|
0.47%
1/215
|
|
Vascular disorders
Deep vein thrombosis
|
0.93%
1/108
|
0.00%
0/107
|
1.4%
3/215
|
|
Vascular disorders
Aortic aneurysm
|
0.93%
1/108
|
0.00%
0/107
|
0.47%
1/215
|
|
Vascular disorders
Hypertension
|
0.00%
0/108
|
0.93%
1/107
|
0.47%
1/215
|
|
Vascular disorders
Hypertensive crisis
|
0.93%
1/108
|
0.93%
1/107
|
0.00%
0/215
|
|
Vascular disorders
Hypotension
|
0.00%
0/108
|
0.00%
0/107
|
0.93%
2/215
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/108
|
0.93%
1/107
|
0.47%
1/215
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/108
|
0.00%
0/107
|
0.47%
1/215
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/108
|
0.00%
0/107
|
0.47%
1/215
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/108
|
0.00%
0/107
|
0.47%
1/215
|
Other adverse events
| Measure |
Epoetin Alfa QW
n=108 participants at risk
Continue pre-study once weekly dose of epoetin alfa for 36 weeks
|
Epoetin Alfa Q2W
n=107 participants at risk
Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
|
Epoetin Alfa Q4W
n=215 participants at risk
Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.6%
6/108
|
4.7%
5/107
|
4.7%
10/215
|
|
Gastrointestinal disorders
Diarrhoea
|
7.4%
8/108
|
4.7%
5/107
|
6.5%
14/215
|
|
Gastrointestinal disorders
Constipation
|
4.6%
5/108
|
4.7%
5/107
|
7.0%
15/215
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
6/108
|
5.6%
6/107
|
4.7%
10/215
|
|
Gastrointestinal disorders
Nausea
|
2.8%
3/108
|
5.6%
6/107
|
5.6%
12/215
|
|
General disorders
Oedema
|
4.6%
5/108
|
12.1%
13/107
|
7.4%
16/215
|
|
General disorders
Oedema peripheral
|
5.6%
6/108
|
9.3%
10/107
|
6.5%
14/215
|
|
General disorders
Fatigue
|
5.6%
6/108
|
4.7%
5/107
|
7.0%
15/215
|
|
Infections and infestations
Urinary tract infection
|
11.1%
12/108
|
7.5%
8/107
|
6.0%
13/215
|
|
Infections and infestations
Nasopharyngitis
|
3.7%
4/108
|
5.6%
6/107
|
7.0%
15/215
|
|
Infections and infestations
Upper respiratory tract infection
|
6.5%
7/108
|
5.6%
6/107
|
4.2%
9/215
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
6.5%
7/108
|
6.5%
7/107
|
8.4%
18/215
|
|
Metabolism and nutrition disorders
Gout
|
5.6%
6/108
|
3.7%
4/107
|
3.3%
7/215
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.6%
6/108
|
4.7%
5/107
|
4.7%
10/215
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.6%
5/108
|
3.7%
4/107
|
5.1%
11/215
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.5%
7/108
|
4.7%
5/107
|
3.3%
7/215
|
|
Nervous system disorders
Dizziness
|
2.8%
3/108
|
6.5%
7/107
|
8.4%
18/215
|
|
Nervous system disorders
Headache
|
4.6%
5/108
|
5.6%
6/107
|
6.5%
14/215
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.9%
2/108
|
6.5%
7/107
|
7.0%
15/215
|
|
Vascular disorders
Hypertension
|
10.2%
11/108
|
13.1%
14/107
|
11.2%
24/215
|
Additional Information
Peter Bowers
J&J PRD
Phone: 908-927-2116
Results disclosure agreements
- Principal investigator is a sponsor employee Generally, the only disclosure restriction on the PI is that the sponsor has 60 days to review results communications prior to public release and can embargo communications regarding trial results for a period that does not exceed 180 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER