Trial Outcomes & Findings for Dynepo Infrequent Dosing Study (NCT NCT00450333)
NCT ID: NCT00450333
Last Updated: 2021-06-14
Results Overview
This study terminated early due to a decision by Shire Pharmaceuticals to permanently cease marketing Dynepo due to commercial reasons, it was not the result of any safety signal. Not enough subjects completed the study to do any efficacy analyses.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
407 participants
Primary outcome timeframe
Baseline and 24 weeks
Results posted on
2021-06-14
Participant Flow
This study was terminated on July 31, 2008 as a result of a decision by Shire Pharmaceutical to permanently cease marketing Dynepo and withdraw the Marketing Authorisation. The decision was for commercial reasons, it was not the result of any safety signal. Not enough subjects completed the study to do any efficacy analyses.
Erythropoietin (EPO)-naive subjects were randomized to receive Dynepo (Epoetin delta) once weekly (QW) or twice weekly (BIW) and subjects who were already stable on EPO (doses \< or equal to 10,000 IU/week) were randomized to receive Dynepo once every 2 weeks (Q2W) or once weekly.
Participant milestones
| Measure |
Dynepo (Epoetin Delta)-Naive Once-weekly (QW)
Erythropoietin(EPO)-naive subjects receiving Epoetin delta once weekly (QW)
|
Dynepo-naive Twice-weekly (BIW)
EPO-naive subjects receiving Epoetin delta twice weekly (BIW)
|
Dynepo Once Every 2 Weeks (Q2W)
EPO stable subjects receiving Epoetin delta once every 2 weeks (Q2W)
|
Dynepo QW
EPO stable subjects receiving Epoetin delta once weekly (QW)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
98
|
107
|
100
|
102
|
|
Overall Study
COMPLETED
|
44
|
44
|
75
|
74
|
|
Overall Study
NOT COMPLETED
|
54
|
63
|
25
|
28
|
Reasons for withdrawal
| Measure |
Dynepo (Epoetin Delta)-Naive Once-weekly (QW)
Erythropoietin(EPO)-naive subjects receiving Epoetin delta once weekly (QW)
|
Dynepo-naive Twice-weekly (BIW)
EPO-naive subjects receiving Epoetin delta twice weekly (BIW)
|
Dynepo Once Every 2 Weeks (Q2W)
EPO stable subjects receiving Epoetin delta once every 2 weeks (Q2W)
|
Dynepo QW
EPO stable subjects receiving Epoetin delta once weekly (QW)
|
|---|---|---|---|---|
|
Overall Study
Study terminated
|
47
|
54
|
16
|
21
|
|
Overall Study
Adverse Event
|
1
|
7
|
2
|
2
|
|
Overall Study
Protocol Violation
|
1
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
3
|
0
|
|
Overall Study
Kidney transplant
|
1
|
0
|
1
|
3
|
|
Overall Study
Death
|
3
|
2
|
2
|
2
|
Baseline Characteristics
Dynepo Infrequent Dosing Study
Baseline characteristics by cohort
| Measure |
Dynepo (Epoetin Delta)-Naive Once-weekly (QW)
n=98 Participants
Erythropoietin(EPO)-naive subjects receiving Epoetin delta once weekly (QW)
|
Dynepo-naive Twice-weekly (BIW)
n=107 Participants
EPO-naive subjects receiving Epoetin delta twice weekly (BIW)
|
Dynepo Once Every 2 Weeks (Q2W)
n=100 Participants
EPO stable subjects receiving Epoetin delta once every 2 weeks (Q2W)
|
Dynepo QW
n=102 Participants
EPO stable subjects receiving Epoetin delta once weekly (QW)
|
Total
n=407 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
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
37 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
155 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
61 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
67 Participants
n=4 Participants
|
252 Participants
n=21 Participants
|
|
Age, Continuous
|
66.2 years
STANDARD_DEVIATION 14.97 • n=5 Participants
|
67.0 years
STANDARD_DEVIATION 12.45 • n=7 Participants
|
64.2 years
STANDARD_DEVIATION 13.86 • n=5 Participants
|
65.5 years
STANDARD_DEVIATION 16.04 • n=4 Participants
|
65.7 years
STANDARD_DEVIATION 14.33 • n=21 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
160 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
247 Participants
n=21 Participants
|
|
Region of Enrollment
France
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
|
Region of Enrollment
Spain
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
|
Region of Enrollment
Belgium
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
|
Region of Enrollment
Austria
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Region of Enrollment
Germany
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
60 Participants
n=21 Participants
|
|
Region of Enrollment
United Kingdom
|
10 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
48 Participants
n=21 Participants
|
|
Region of Enrollment
Italy
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
73 Participants
n=21 Participants
|
|
Region of Enrollment
Australia
|
19 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
54 Participants
n=21 Participants
|
|
Region of Enrollment
Hungary
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Region of Enrollment
Latvia
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
|
Region of Enrollment
Lithuania
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Region of Enrollment
New Zealand
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline and 24 weeksPopulation: This study terminated early due to a decision by Shire Pharmaceuticals to permanently cease marketing Dynepo due to commercial reasons, it was not the result of any safety signal. Not enough subjects completed the study to do any efficacy analyses.
This study terminated early due to a decision by Shire Pharmaceuticals to permanently cease marketing Dynepo due to commercial reasons, it was not the result of any safety signal. Not enough subjects completed the study to do any efficacy analyses.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: week 16 and 24Population: This study terminated early due to a decision by Shire Pharmaceuticals to permanently cease marketing Dynepo due to commercial reasons, it was not the result of any safety signal. Not enough subjects completed the study to do any efficacy analyses.
This study terminated early due to a decision by Shire Pharmaceuticals to permanently cease marketing Dynepo due to commercial reasons, it was not the result of any safety signal. Not enough subjects completed the study to do any efficacy analyses.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Weeks 16 and 24Population: This study terminated early due to a decision by Shire Pharmaceuticals to permanently cease marketing Dynepo due to commercial reasons, it was not the result of any safety signal. Not enough subjects completed the study to do any efficacy analyses.
This study terminated early due to a decision by Shire Pharmaceuticals to permanently cease marketing Dynepo due to commercial reasons, it was not the result of any safety signal. Not enough subjects completed the study to do any efficacy analyses.
Outcome measures
Outcome data not reported
Adverse Events
Dynepo (Epoetin Delta)-Naive Once-weekly (QW)
Serious events: 15 serious events
Other events: 59 other events
Deaths: 0 deaths
Dynepo-naive Twice-weekly (BIW)
Serious events: 23 serious events
Other events: 50 other events
Deaths: 0 deaths
Dynepo Once Every 2 Weeks (Q2W)
Serious events: 23 serious events
Other events: 44 other events
Deaths: 0 deaths
Dynepo QW
Serious events: 20 serious events
Other events: 44 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dynepo (Epoetin Delta)-Naive Once-weekly (QW)
n=98 participants at risk
Erythropoietin(EPO)-naive subjects receiving Epoetin delta once weekly (QW)
|
Dynepo-naive Twice-weekly (BIW)
n=107 participants at risk
EPO-naive subjects receiving Epoetin delta twice weekly (BIW)
|
Dynepo Once Every 2 Weeks (Q2W)
n=100 participants at risk
EPO stable subjects receiving Epoetin delta once every 2 weeks (Q2W)
|
Dynepo QW
n=102 participants at risk
EPO stable subjects receiving Epoetin delta once weekly (QW)
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/98
|
0.93%
1/107
|
0.00%
0/100
|
0.00%
0/102
|
|
Blood and lymphatic system disorders
DIC
|
0.00%
0/98
|
0.93%
1/107
|
0.00%
0/100
|
0.00%
0/102
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/98
|
0.00%
0/107
|
1.0%
1/100
|
0.98%
1/102
|
|
Cardiac disorders
Acute MI
|
0.00%
0/98
|
0.93%
1/107
|
1.0%
1/100
|
0.00%
0/102
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/98
|
0.93%
1/107
|
1.0%
1/100
|
2.0%
2/102
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/98
|
0.93%
1/107
|
2.0%
2/100
|
0.00%
0/102
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/98
|
0.00%
0/107
|
1.0%
1/100
|
0.00%
0/102
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/98
|
0.00%
0/107
|
0.00%
0/100
|
0.98%
1/102
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
1.0%
1/98
|
0.93%
1/107
|
1.0%
1/100
|
2.0%
2/102
|
|
Gastrointestinal disorders
Peritonitis
|
3.1%
3/98
|
0.00%
0/107
|
1.0%
1/100
|
2.0%
2/102
|
|
Infections and infestations
Pneumonia
|
1.0%
1/98
|
1.9%
2/107
|
0.00%
0/100
|
0.00%
0/102
|
|
Investigations
Hemoglobin decreased
|
1.0%
1/98
|
0.00%
0/107
|
0.00%
0/100
|
0.00%
0/102
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.0%
1/98
|
0.00%
0/107
|
0.00%
0/100
|
0.00%
0/102
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/98
|
0.93%
1/107
|
0.00%
0/100
|
0.00%
0/102
|
|
Nervous system disorders
Brain stem hemorrhage
|
0.00%
0/98
|
0.93%
1/107
|
0.00%
0/100
|
0.00%
0/102
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/98
|
0.93%
1/107
|
0.00%
0/100
|
0.00%
0/102
|
|
Nervous system disorders
Hypoglycemic coma
|
0.00%
0/98
|
0.93%
1/107
|
0.00%
0/100
|
0.00%
0/102
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/98
|
0.00%
0/107
|
1.0%
1/100
|
0.00%
0/102
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/98
|
0.93%
1/107
|
0.00%
0/100
|
0.00%
0/102
|
|
Vascular disorders
Hypertension
|
0.00%
0/98
|
1.9%
2/107
|
2.0%
2/100
|
2.0%
2/102
|
|
Cardiac disorders
Angina
|
0.00%
0/98
|
1.9%
2/107
|
1.0%
1/100
|
2.9%
3/102
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/98
|
0.93%
1/107
|
0.00%
0/100
|
0.98%
1/102
|
|
Cardiac disorders
Cardiac arrest
|
1.0%
1/98
|
0.00%
0/107
|
0.00%
0/100
|
0.98%
1/102
|
|
Cardiac disorders
Coronary artery disease
|
1.0%
1/98
|
0.00%
0/107
|
0.00%
0/100
|
0.00%
0/102
|
|
Cardiac disorders
Tachycardia
|
1.0%
1/98
|
0.00%
0/107
|
0.00%
0/100
|
0.00%
0/102
|
|
Cardiac disorders
Ischemic cardiomyopathy
|
0.00%
0/98
|
0.00%
0/107
|
1.0%
1/100
|
2.0%
2/102
|
|
Nervous system disorders
Intercranial hemorrhage
|
0.00%
0/98
|
0.00%
0/107
|
0.00%
0/100
|
0.98%
1/102
|
|
Vascular disorders
Thrombosis
|
0.00%
0/98
|
0.00%
0/107
|
0.00%
0/100
|
0.98%
1/102
|
|
Vascular disorders
Hypotension
|
1.0%
1/98
|
0.00%
0/107
|
0.00%
0/100
|
0.00%
0/102
|
|
Vascular disorders
Hemorrhage
|
1.0%
1/98
|
0.00%
0/107
|
0.00%
0/100
|
0.00%
0/102
|
|
Vascular disorders
Peripheral ischemia
|
0.00%
0/98
|
0.93%
1/107
|
0.00%
0/100
|
0.00%
0/102
|
|
Vascular disorders
Arterial occlusive disease
|
0.00%
0/98
|
0.93%
1/107
|
0.00%
0/100
|
0.00%
0/102
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/98
|
0.93%
1/107
|
1.0%
1/100
|
0.00%
0/102
|
|
Gastrointestinal disorders
Duodenal ulcer hemorrhage
|
1.0%
1/98
|
0.93%
1/107
|
0.00%
0/100
|
0.00%
0/102
|
|
Gastrointestinal disorders
Intestinal fistula
|
1.0%
1/98
|
0.00%
0/107
|
0.00%
0/100
|
0.00%
0/102
|
|
General disorders
Catheter related complication
|
0.00%
0/98
|
0.00%
0/107
|
1.0%
1/100
|
0.00%
0/102
|
|
General disorders
Catheter thrombosis
|
1.0%
1/98
|
0.00%
0/107
|
0.00%
0/100
|
0.00%
0/102
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/98
|
0.00%
0/107
|
2.0%
2/100
|
0.00%
0/102
|
|
Infections and infestations
Sepsis
|
1.0%
1/98
|
0.93%
1/107
|
1.0%
1/100
|
0.98%
1/102
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/98
|
0.93%
1/107
|
1.0%
1/100
|
0.00%
0/102
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula complication
|
1.0%
1/98
|
0.93%
1/107
|
2.0%
2/100
|
0.00%
0/102
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/98
|
0.00%
0/107
|
1.0%
1/100
|
0.00%
0/102
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnea
|
0.00%
0/98
|
0.00%
0/107
|
1.0%
1/100
|
0.00%
0/102
|
Other adverse events
| Measure |
Dynepo (Epoetin Delta)-Naive Once-weekly (QW)
n=98 participants at risk
Erythropoietin(EPO)-naive subjects receiving Epoetin delta once weekly (QW)
|
Dynepo-naive Twice-weekly (BIW)
n=107 participants at risk
EPO-naive subjects receiving Epoetin delta twice weekly (BIW)
|
Dynepo Once Every 2 Weeks (Q2W)
n=100 participants at risk
EPO stable subjects receiving Epoetin delta once every 2 weeks (Q2W)
|
Dynepo QW
n=102 participants at risk
EPO stable subjects receiving Epoetin delta once weekly (QW)
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
5.1%
5/98
|
2.8%
3/107
|
3.0%
3/100
|
3.9%
4/102
|
|
Gastrointestinal disorders
Nausea
|
6.1%
6/98
|
1.9%
2/107
|
2.0%
2/100
|
2.0%
2/102
|
|
General disorders
Edema peripheral
|
5.1%
5/98
|
4.7%
5/107
|
2.0%
2/100
|
2.9%
3/102
|
|
Infections and infestations
Bronchitis
|
2.0%
2/98
|
3.7%
4/107
|
8.0%
8/100
|
3.9%
4/102
|
|
Infections and infestations
Influenza
|
5.1%
5/98
|
0.93%
1/107
|
0.00%
0/100
|
3.9%
4/102
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
7.1%
7/98
|
0.93%
1/107
|
0.00%
0/100
|
2.0%
2/102
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
5.1%
5/98
|
4.7%
5/107
|
3.0%
3/100
|
0.98%
1/102
|
|
Metabolism and nutrition disorders
Iron deficiency
|
5.1%
5/98
|
1.9%
2/107
|
0.00%
0/100
|
0.00%
0/102
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.1%
7/98
|
1.9%
2/107
|
2.0%
2/100
|
2.0%
2/102
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/98
|
1.9%
2/107
|
2.0%
2/100
|
5.9%
6/102
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.0%
1/98
|
0.00%
0/107
|
5.0%
5/100
|
2.0%
2/102
|
|
Nervous system disorders
Headache
|
3.1%
3/98
|
7.5%
8/107
|
4.0%
4/100
|
2.0%
2/102
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.0%
1/98
|
3.7%
4/107
|
5.0%
5/100
|
2.9%
3/102
|
|
Vascular disorders
Hypertension
|
6.1%
6/98
|
8.4%
9/107
|
3.0%
3/100
|
5.9%
6/102
|
|
Vascular disorders
Hypotension
|
1.0%
1/98
|
1.9%
2/107
|
5.0%
5/100
|
2.9%
3/102
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
- Publication restrictions are in place
Restriction type: OTHER