Trial Outcomes & Findings for Efficacy and Safety of Venofer (Iron Sucrose Injection USP) in Patients Receiving Peritoneal Dialysis (NCT NCT00236938)
NCT ID: NCT00236938
Last Updated: 2021-05-19
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
121 participants
Primary outcome timeframe
Change from Baseline up to Day 71
Results posted on
2021-05-19
Participant Flow
Recruitment Period: July 29, 2002 - September 6, 2004 Locations: Hospitals and Medical Clinics
Participant milestones
| Measure |
Group A: Venofer and Erythropoietin EPO Fixed Dose
Fixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29.
|
Group B: Erythropoietin EPO Fixed Dose Only
Stable erythropoietin (EPO) dose and no supplemental iron.
|
|---|---|---|
|
Overall Study
STARTED
|
75
|
46
|
|
Overall Study
COMPLETED
|
62
|
26
|
|
Overall Study
NOT COMPLETED
|
13
|
20
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of Venofer (Iron Sucrose Injection USP) in Patients Receiving Peritoneal Dialysis
Baseline characteristics by cohort
| Measure |
Group A: Venofer and Erythropoietin EPO Fixed Dose
n=75 Participants
Fixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29.
|
Group B: Erythropoietin EPO Fixed Dose Only
n=46 Participants
Stable erythropoietin (EPO) dose and no supplemental iron.
|
Total
n=121 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
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
61 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change from Baseline up to Day 71Population: Intent-to-Treat Population (ITT): All safety population subjects who received at least 1 dose of study medication or EPO and had at least 1 post-baseline efficacy measurement.
Outcome measures
| Measure |
Group A: Venofer and Erythropoietin EPO Fixed Dose
n=66 Participants
Fixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29.
|
Group B: Erythropoietin EPO Fixed Dose Only
n=30 Participants
Stable erythropoietin (EPO) dose and no supplemental iron.
|
|---|---|---|
|
Mean Change From Baseline to the Highest Hemoglobin up to Day 71
|
1.3 g/dL
Standard Deviation 1.10
|
.7 g/dL
Standard Deviation 1.10
|
SECONDARY outcome
Timeframe: Change from Baseline up to Day 71Population: Intent-to-Treat Population (ITT)
Outcome measures
| Measure |
Group A: Venofer and Erythropoietin EPO Fixed Dose
n=66 Participants
Fixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29.
|
Group B: Erythropoietin EPO Fixed Dose Only
n=30 Participants
Stable erythropoietin (EPO) dose and no supplemental iron.
|
|---|---|---|
|
The Mean Change From Baseline to the Highest Serum Transferrin Saturation (TSAT) up to Day 71
|
18.176 percentage of change
Standard Deviation 15.53
|
10.383 percentage of change
Standard Deviation 12.27
|
SECONDARY outcome
Timeframe: Change from Baseline up to Day 71Population: Intent-to-Treat Population (ITT)
Outcome measures
| Measure |
Group A: Venofer and Erythropoietin EPO Fixed Dose
n=66 Participants
Fixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29.
|
Group B: Erythropoietin EPO Fixed Dose Only
n=30 Participants
Stable erythropoietin (EPO) dose and no supplemental iron.
|
|---|---|---|
|
The Mean Change From Baseline to the Highest Ferritin up to Day 71
|
545.05 ng/mL
Standard Deviation 585.8
|
70.523 ng/mL
Standard Deviation 159.7
|
SECONDARY outcome
Timeframe: Change from Baseline up to Day 71Population: Intent-to-Treat Population (ITT)
Outcome measures
| Measure |
Group A: Venofer and Erythropoietin EPO Fixed Dose
n=66 Participants
Fixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29.
|
Group B: Erythropoietin EPO Fixed Dose Only
n=30 Participants
Stable erythropoietin (EPO) dose and no supplemental iron.
|
|---|---|---|
|
The Mean Change From Baseline to the Highest Reticulocyte Count up to Day 71
|
0.7226 percentage of change
Standard Deviation 1.36
|
0.4630 percentage of change
Standard Deviation 1.01
|
Adverse Events
Group A: Venofer and Erythropoietin EPO Fixed Dose
Serious events: 9 serious events
Other events: 33 other events
Deaths: 0 deaths
Group B: Erythropoietin EPO Fixed Dose Only
Serious events: 5 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group A: Venofer and Erythropoietin EPO Fixed Dose
n=75 participants at risk
Fixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29.
|
Group B: Erythropoietin EPO Fixed Dose Only
n=46 participants at risk
Stable erythropoietin (EPO) dose and no supplemental iron.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia NOS
|
1.3%
1/75 • Number of events 1 • 2 years and 2 months
|
0.00%
0/46 • 2 years and 2 months
|
|
Cardiac disorders
Cardio-respiratory arrest
|
1.3%
1/75 • Number of events 1 • 2 years and 2 months
|
0.00%
0/46 • 2 years and 2 months
|
|
Injury, poisoning and procedural complications
Fall
|
1.3%
1/75 • Number of events 1 • 2 years and 2 months
|
0.00%
0/46 • 2 years and 2 months
|
|
Injury, poisoning and procedural complications
Fibula Fracture
|
1.3%
1/75 • Number of events 1 • 2 years and 2 months
|
0.00%
0/46 • 2 years and 2 months
|
|
Vascular disorders
Gangrene NOS
|
1.3%
1/75 • Number of events 1 • 2 years and 2 months
|
0.00%
0/46 • 2 years and 2 months
|
|
Metabolism and nutrition disorders
Hyperglycemia NOS
|
0.00%
0/75 • 2 years and 2 months
|
2.2%
1/46 • Number of events 1 • 2 years and 2 months
|
|
Vascular disorders
Hypertension NOS
|
0.00%
0/75 • 2 years and 2 months
|
2.2%
1/46 • Number of events 1 • 2 years and 2 months
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
1.3%
1/75 • Number of events 1 • 2 years and 2 months
|
0.00%
0/46 • 2 years and 2 months
|
|
Infections and infestations
Localized infection
|
0.00%
0/75 • 2 years and 2 months
|
2.2%
1/46 • Number of events 1 • 2 years and 2 months
|
|
Musculoskeletal and connective tissue disorders
Lower limb fracture NOS
|
0.00%
0/75 • 2 years and 2 months
|
2.2%
1/46 • Number of events 1 • 2 years and 2 months
|
|
Infections and infestations
Lymph node tuberculosis NOS
|
1.3%
1/75 • Number of events 1 • 2 years and 2 months
|
0.00%
0/46 • 2 years and 2 months
|
|
Cardiac disorders
Myocardial infarction
|
1.3%
1/75 • Number of events 1 • 2 years and 2 months
|
0.00%
0/46 • 2 years and 2 months
|
|
Infections and infestations
Peritoneal infection
|
2.7%
2/75 • Number of events 2 • 2 years and 2 months
|
4.3%
2/46 • Number of events 2 • 2 years and 2 months
|
|
Infections and infestations
Upper respiratory tract infection NOS
|
1.3%
1/75 • Number of events 1 • 2 years and 2 months
|
0.00%
0/46 • 2 years and 2 months
|
Other adverse events
| Measure |
Group A: Venofer and Erythropoietin EPO Fixed Dose
n=75 participants at risk
Fixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29.
|
Group B: Erythropoietin EPO Fixed Dose Only
n=46 participants at risk
Stable erythropoietin (EPO) dose and no supplemental iron.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain NOS
|
4.0%
3/75 • Number of events 5 • 2 years and 2 months
|
6.5%
3/46 • Number of events 3 • 2 years and 2 months
|
|
Infections and infestations
Catheter site infection
|
4.0%
3/75 • Number of events 3 • 2 years and 2 months
|
8.7%
4/46 • Number of events 4 • 2 years and 2 months
|
|
Gastrointestinal disorders
Constipation
|
4.0%
3/75 • Number of events 3 • 2 years and 2 months
|
6.5%
3/46 • Number of events 3 • 2 years and 2 months
|
|
Gastrointestinal disorders
Diarrhea NOS
|
8.0%
6/75 • Number of events 9 • 2 years and 2 months
|
4.3%
2/46 • Number of events 2 • 2 years and 2 months
|
|
Vascular disorders
Hypertension NOS
|
8.0%
6/75 • Number of events 6 • 2 years and 2 months
|
4.3%
2/46 • Number of events 2 • 2 years and 2 months
|
|
Gastrointestinal disorders
Nausea
|
5.3%
4/75 • Number of events 6 • 2 years and 2 months
|
4.3%
2/46 • Number of events 2 • 2 years and 2 months
|
|
General disorders
Oedema peripheral
|
5.3%
4/75 • Number of events 6 • 2 years and 2 months
|
10.9%
5/46 • Number of events 6 • 2 years and 2 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.7%
2/75 • Number of events 2 • 2 years and 2 months
|
6.5%
3/46 • Number of events 3 • 2 years and 2 months
|
|
Infections and infestations
Peritoneal infection
|
5.3%
4/75 • Number of events 4 • 2 years and 2 months
|
6.5%
3/46 • Number of events 3 • 2 years and 2 months
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
6.7%
5/75 • Number of events 6 • 2 years and 2 months
|
0.00%
0/46 • 2 years and 2 months
|
|
Gastrointestinal disorders
Vomiting NOS
|
8.0%
6/75 • Number of events 8 • 2 years and 2 months
|
2.2%
1/46 • Number of events 1 • 2 years and 2 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60